Imatinib Mesylate and Combination Chemotherapy in Treating Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia
Status: | Recruiting |
---|---|
Conditions: | Other Indications, Blood Cancer |
Therapuetic Areas: | Oncology, Other |
Healthy: | No |
Age Range: | 2 - 21 |
Updated: | 2/17/2019 |
Start Date: | July 28, 2017 |
End Date: | June 30, 2028 |
International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones
This randomized phase III trial studies how well imatinib mesylate and combination
chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive
acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by
blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in
different ways to stop the growth of cancer cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Giving imatinib mesylate and
combination chemotherapy may work better in treating patients with Philadelphia chromosome
positive acute lymphoblastic leukemia.
chemotherapy work in treating patients with newly diagnosed Philadelphia chromosome positive
acute lymphoblastic leukemia. Imatinib mesylate may stop the growth of cancer cells by
blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, work in
different ways to stop the growth of cancer cells, either by killing the cells, by stopping
them from dividing, or by stopping them from spreading. Giving imatinib mesylate and
combination chemotherapy may work better in treating patients with Philadelphia chromosome
positive acute lymphoblastic leukemia.
PRIMARY OBJECTIVES:
I. To compare disease-free survival (DFS) of standard risk pediatric Philadelphia chromosome
(Ph)+ acute lymphoblastic leukemia (ALL) treated with continuous imatinib mesylate (imatinib)
combined with either a high-risk Children's Oncology Group (COG) ALL chemotherapy backbone or
the more intensive European (Es)PhALL chemotherapy backbone.
SECONDARY OBJECTIVES:
I. To determine the feasibility of administration of imatinib after allogeneic hematopoietic
stem cell transplantation (HSCT) in high risk Ph+ ALL patients.
II. To determine event-free survival (EFS) of high risk pediatric Ph+ ALL patients treated
with EsPhALL chemotherapy, HSCT in first complete remission and post-HSCT imatinib.
III. To compare rates of grade 3 or higher infections in standard risk (SR) Ph+ ALL patients
between the two randomized arms.
IV. To evaluate event free survival (EFS) and overall survival (OS) of all enrolled
participants.
V. To evaluate OS in SR patients. VI. To evaluate OS in high risk (HR) patients.
TERTIARY OBJECTIVES:
I. To describe the toxicities associated with post-HSCT administration of imatinib.
II. To evaluate the long-term toxicities in SR patients treated with chemotherapy plus
imatinib (no transplant), overall and between both randomized arms.
III. To determine prognostic significance of minimal residual disease (MRD) in Ph+ ALL at
various time points during therapy.
IV. To evaluate MRD in HR patients just prior to HSCT and then at regular intervals post-HSCT
and explore the association of these measurements with long-term outcome.
V. To evaluate concordance of MRD assessments made by IGH-T cell receptor (TCR) polymerase
chain reaction (PCR) assay and next generation sequencing (NGS) assays.
VI. To determine prognostic significance of IKZF1 gene aberrations and deletions.
VII. To determine frequency and prognostic significance of p190 and p210 BCR-ABL1 fusion
variants in pediatric Ph+ ALL.
VIII. To measure adherence to oral chemotherapeutic agents (imatinib, 6-mercaptopurine, and
methotrexate) during the maintenance phase in SR Ph+ ALL patients.
IX. To identify factors associated with poor adherence. X. To determine association between
relapse risk and adherence to each oral chemotherapeutic agent (separately and combined).
XI. To measure adherence to imatinib after allogeneic HSCT in HR Ph+ ALL patients and
identify factors associated with poor adherence.
OUTLINE:
INDUCTION IA PART 1: Patients receive induction IA according to standard of care on days
1-14.
INDUCTION IA PART 2: Patients receive imatinib mesylate orally (PO) once daily (QD) or twice
daily (BID) on days 15-33, prednisolone PO twice daily (BID) or methylprednisolone
intravenously (IV) on days 15-28, vincristine sulfate IV over 1 minute on days 15 and 22,
daunorubicin hydrochloride IV over 1-15 minutes on days 15 and 22, and methotrexate
intrathecally (IT) on day 29.
INDUCTION IB: Patients receive imatinib mesylate PO QD or BID on days 1-35, cyclophosphamide
IV over 30-60 minutes on days 1 and 28, mercaptopurine PO on days 1-28, cytarabine IV or
subcutaneously (SC) on days 1-4, 8-11, 15-18, and 22-25, and methotrexate IT on days 8 and
22.
POST-INDUCTION THERAPY: Patients with standard risk are randomized to 1 of 2 arms. Patients
with high risk are assigned to Arm C.
ARM A:
CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate PO QD or BID on days 1-21,
methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose
methotrexate IV over 24 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 6,
dexamethasone PO BID or IV on days 1-5, cyclophosphamide IV over 30-60 minutes on days 2-4,
leucovorin calcium PO or IV on days 3 and 4, high dose cytarabine IV over 3 hours and
pegaspargase IV over 1-2 hours on day 5, and filgrastim SC on days 7-11 in the absence of
disease progression or unexpected toxicity.
CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate PO QD or BID on days 1-21,
methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose
methotrexate IV over 24 hours on day 1, dexamethasone PO BID or IV on days 1-5, vincristine
sulfate IV over 1 minute on days 1 and 6, ifosfamide IV over 1 hour on days 2-4, leucovorin
calcium PO or IV on days 3 and 4, dexrazoxane hydrochloride IV over 5-15 minutes and
daunorubicin hydrochloride IV over 1-15 minutes on day 5, pegaspargase IV over 1-2 hours on
day 6, and filgrastim SC on days 7-11 in the absence of disease progression or unexpected
toxicity.
CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate PO QD or BID on days 1-21, high
dose cytarabine IV over 3 hours on days 1-2, dexamethasone PO BID or IV on days 1-5,
etoposide IV over 1-2 hours on days 3-5, methotrexate IT, cytarabine IT, and therapeutic
hydrocortisone IT on day 5, pegaspargase IV over 1-2 hours on day 6, and filgrastim SC on
days 7-11 in the absence of disease progression or unexpected toxicity.
DELAYED INTENSIFICATION 1 PART 1: Patients receive imatinib mesylate PO QD or BID on days
1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine
sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV
over 1-15 minutes on days 8, 15, 22, and 29, and pegaspargase IV over 1-2 hours on day 8 in
the absence of disease progression or unexpected toxicity.
DELAYED INTENSIFICATION 1 PART 2: Patients receive imatinib mesylate PO QD on days 36-63,
cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV
over 1-30 minutes or SC on days 36-39 and 43-46, and methotrexate IT on days 36 and 43 in the
absence of disease progression or unexpected toxicity.
INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-28,
methotrexate PO on days 1, 8, 15, and 22, and mercaptopurine PO on days 1-28 in the absence
of disease progression or unexpected toxicity.
DELAYED INTENSIFICATION 2 PART 1: Patients receive imatinib mesylate PO QD or BID on days
1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine
sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV
over 1-15 minutes on days 8, 15, 22, and 29, and pegaspargase IV over 1-2 hours on day 8 in
the absence of disease progression or unexpected toxicity.
DELAYED INTENSIFICATION 2 PART 2: Patients receive imatinib mesylate PO QD on days 36-49,
cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV
over 1-30 minutes or SC on days 36-39 and 43-46, and methotrexate IT on days 36 and 43 in the
absence of disease progression or unexpected toxicity.
MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, methotrexate PO
once weekly (QW) and IT on days 1 and 43 of courses 1, 2, and 3, and mercaptopurine PO on
days 1-84. Courses with imatinib mesylate and mercaptopurine repeat every 84 days for up to
104 weeks from the start of Induction IA in the absence of disease progression or unexpected
toxicity.
ARM B:
INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-63,
vincristine sulfate IV over 1 minute and high dose methotrexate IV over 24 hours on days 1,
15, 29, and 43, leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46,
mercaptopurine PO on days 1-56, and methotrexate IT on days 1 and 29 in the absence of
disease progression or unexpected toxicity.
DELAYED INTENSIFICATION PART 1: Patients receive imatinib mesylate PO QD or BID on days 1-28,
methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine
sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV
over 1-15 minutes on days 1, 8, and 15, and pegaspargase IV over 1-2 hours on day 4 in the
absence of disease progression or unexpected toxicity.
DELAYED INTENSIFICATION PART 2: Patients receive imatinib mesylate PO QD on days 29-56,
cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV
over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36,
vincristine sulfate IV over 1 minute on days 43 and 50, and pegaspargase IV over 1-2 hours on
day 43 in the absence of disease progression or unexpected toxicity.
INTERIM MAINTENANCE WITH CAPIZZI METHOTREXATE: Patients receive imatinib mesylate PO QD or
BID on days 1-56, vincristine sulfate IV over 1 minute and methotrexate IV over 2-15 minutes
on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase IV over 1-2
hours on days 2 and 22 in the absence of disease progression or unexpected toxicity.
MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, vincristine
sulfate IV over 1 minute on days 1, 29, and 57, prednisolone PO BID (or methylprednisolone IV
for course 1 and 2) on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84,
methotrexate PO QW, and methotrexate IT on day 1 (and day 29 for course 1 and 2). Courses
repeat every 84 days for up to 104 weeks from the start of Induction IA in the absence of
disease progression or unexpected toxicity.
ARM C:
CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate, methotrexate, cytarabine,
therapeutic hydrocortisone, high dose methotrexate, vincristine sulfate, dexamethasone,
leucovorin calcium, high dose cytarabine, and pegaspargase as in Arm A Consolidation Block 1,
and filgrastim SC on day 7 in the absence of disease progression or unexpected toxicity.
CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate, methotrexate, cytarabine,
therapeutic hydrocortisone, high dose methotrexate, dexamethasone, vincristine sulfate,
ifosfamide, leucovorin calcium, dexrazoxane hydrochloride, daunorubicin hydrochloride,
pegaspargase, and filgrastim as Arm A Consolidation Block 2 in the absence of disease
progression or unexpected toxicity.
CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate, dexamethasone, etoposide,
methotrexate, cytarabine, therapeutic hydrocortisone, pegaspargase, and filgrastim as in Arm
A Consolidation Block 3, and high dose cytarabine IV over 3 hours on days 1-2 in the absence
of disease progression or unexpected toxicity.
HSCT: Patients undergo HSCT on day 0. Patients who do not proceed to HSCT receive Delayed
Intensification 1, Interim Maintenance, Delayed Intensification 2, and Maintenance as in Arm
A.
POST-HSCT: Patients receive imatinib mesylate PO QD or BID starting on days 56-365 in the in
the absence of disease progression or unexpected toxicity.
After completion of study treatment, patients are followed up every year for 3 years.
I. To compare disease-free survival (DFS) of standard risk pediatric Philadelphia chromosome
(Ph)+ acute lymphoblastic leukemia (ALL) treated with continuous imatinib mesylate (imatinib)
combined with either a high-risk Children's Oncology Group (COG) ALL chemotherapy backbone or
the more intensive European (Es)PhALL chemotherapy backbone.
SECONDARY OBJECTIVES:
I. To determine the feasibility of administration of imatinib after allogeneic hematopoietic
stem cell transplantation (HSCT) in high risk Ph+ ALL patients.
II. To determine event-free survival (EFS) of high risk pediatric Ph+ ALL patients treated
with EsPhALL chemotherapy, HSCT in first complete remission and post-HSCT imatinib.
III. To compare rates of grade 3 or higher infections in standard risk (SR) Ph+ ALL patients
between the two randomized arms.
IV. To evaluate event free survival (EFS) and overall survival (OS) of all enrolled
participants.
V. To evaluate OS in SR patients. VI. To evaluate OS in high risk (HR) patients.
TERTIARY OBJECTIVES:
I. To describe the toxicities associated with post-HSCT administration of imatinib.
II. To evaluate the long-term toxicities in SR patients treated with chemotherapy plus
imatinib (no transplant), overall and between both randomized arms.
III. To determine prognostic significance of minimal residual disease (MRD) in Ph+ ALL at
various time points during therapy.
IV. To evaluate MRD in HR patients just prior to HSCT and then at regular intervals post-HSCT
and explore the association of these measurements with long-term outcome.
V. To evaluate concordance of MRD assessments made by IGH-T cell receptor (TCR) polymerase
chain reaction (PCR) assay and next generation sequencing (NGS) assays.
VI. To determine prognostic significance of IKZF1 gene aberrations and deletions.
VII. To determine frequency and prognostic significance of p190 and p210 BCR-ABL1 fusion
variants in pediatric Ph+ ALL.
VIII. To measure adherence to oral chemotherapeutic agents (imatinib, 6-mercaptopurine, and
methotrexate) during the maintenance phase in SR Ph+ ALL patients.
IX. To identify factors associated with poor adherence. X. To determine association between
relapse risk and adherence to each oral chemotherapeutic agent (separately and combined).
XI. To measure adherence to imatinib after allogeneic HSCT in HR Ph+ ALL patients and
identify factors associated with poor adherence.
OUTLINE:
INDUCTION IA PART 1: Patients receive induction IA according to standard of care on days
1-14.
INDUCTION IA PART 2: Patients receive imatinib mesylate orally (PO) once daily (QD) or twice
daily (BID) on days 15-33, prednisolone PO twice daily (BID) or methylprednisolone
intravenously (IV) on days 15-28, vincristine sulfate IV over 1 minute on days 15 and 22,
daunorubicin hydrochloride IV over 1-15 minutes on days 15 and 22, and methotrexate
intrathecally (IT) on day 29.
INDUCTION IB: Patients receive imatinib mesylate PO QD or BID on days 1-35, cyclophosphamide
IV over 30-60 minutes on days 1 and 28, mercaptopurine PO on days 1-28, cytarabine IV or
subcutaneously (SC) on days 1-4, 8-11, 15-18, and 22-25, and methotrexate IT on days 8 and
22.
POST-INDUCTION THERAPY: Patients with standard risk are randomized to 1 of 2 arms. Patients
with high risk are assigned to Arm C.
ARM A:
CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate PO QD or BID on days 1-21,
methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose
methotrexate IV over 24 hours on day 1, vincristine sulfate IV over 1 minute on days 1 and 6,
dexamethasone PO BID or IV on days 1-5, cyclophosphamide IV over 30-60 minutes on days 2-4,
leucovorin calcium PO or IV on days 3 and 4, high dose cytarabine IV over 3 hours and
pegaspargase IV over 1-2 hours on day 5, and filgrastim SC on days 7-11 in the absence of
disease progression or unexpected toxicity.
CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate PO QD or BID on days 1-21,
methotrexate IT, cytarabine IT, and therapeutic hydrocortisone IT on day 1, high dose
methotrexate IV over 24 hours on day 1, dexamethasone PO BID or IV on days 1-5, vincristine
sulfate IV over 1 minute on days 1 and 6, ifosfamide IV over 1 hour on days 2-4, leucovorin
calcium PO or IV on days 3 and 4, dexrazoxane hydrochloride IV over 5-15 minutes and
daunorubicin hydrochloride IV over 1-15 minutes on day 5, pegaspargase IV over 1-2 hours on
day 6, and filgrastim SC on days 7-11 in the absence of disease progression or unexpected
toxicity.
CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate PO QD or BID on days 1-21, high
dose cytarabine IV over 3 hours on days 1-2, dexamethasone PO BID or IV on days 1-5,
etoposide IV over 1-2 hours on days 3-5, methotrexate IT, cytarabine IT, and therapeutic
hydrocortisone IT on day 5, pegaspargase IV over 1-2 hours on day 6, and filgrastim SC on
days 7-11 in the absence of disease progression or unexpected toxicity.
DELAYED INTENSIFICATION 1 PART 1: Patients receive imatinib mesylate PO QD or BID on days
1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine
sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV
over 1-15 minutes on days 8, 15, 22, and 29, and pegaspargase IV over 1-2 hours on day 8 in
the absence of disease progression or unexpected toxicity.
DELAYED INTENSIFICATION 1 PART 2: Patients receive imatinib mesylate PO QD on days 36-63,
cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV
over 1-30 minutes or SC on days 36-39 and 43-46, and methotrexate IT on days 36 and 43 in the
absence of disease progression or unexpected toxicity.
INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-28,
methotrexate PO on days 1, 8, 15, and 22, and mercaptopurine PO on days 1-28 in the absence
of disease progression or unexpected toxicity.
DELAYED INTENSIFICATION 2 PART 1: Patients receive imatinib mesylate PO QD or BID on days
1-35, methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine
sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV
over 1-15 minutes on days 8, 15, 22, and 29, and pegaspargase IV over 1-2 hours on day 8 in
the absence of disease progression or unexpected toxicity.
DELAYED INTENSIFICATION 2 PART 2: Patients receive imatinib mesylate PO QD on days 36-49,
cyclophosphamide IV over 30-60 minutes on day 36, thioguanine PO on days 36-49, cytarabine IV
over 1-30 minutes or SC on days 36-39 and 43-46, and methotrexate IT on days 36 and 43 in the
absence of disease progression or unexpected toxicity.
MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, methotrexate PO
once weekly (QW) and IT on days 1 and 43 of courses 1, 2, and 3, and mercaptopurine PO on
days 1-84. Courses with imatinib mesylate and mercaptopurine repeat every 84 days for up to
104 weeks from the start of Induction IA in the absence of disease progression or unexpected
toxicity.
ARM B:
INTERIM MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-63,
vincristine sulfate IV over 1 minute and high dose methotrexate IV over 24 hours on days 1,
15, 29, and 43, leucovorin calcium PO or IV on days 3-4, 17-18, 31-32, and 45-46,
mercaptopurine PO on days 1-56, and methotrexate IT on days 1 and 29 in the absence of
disease progression or unexpected toxicity.
DELAYED INTENSIFICATION PART 1: Patients receive imatinib mesylate PO QD or BID on days 1-28,
methotrexate IT on day 1, dexamethasone PO BID or IV on days 1-7 and 15-21, vincristine
sulfate IV over 1 minute, dexrazoxane hydrochloride IV over 5-15 minutes, and doxorubicin IV
over 1-15 minutes on days 1, 8, and 15, and pegaspargase IV over 1-2 hours on day 4 in the
absence of disease progression or unexpected toxicity.
DELAYED INTENSIFICATION PART 2: Patients receive imatinib mesylate PO QD on days 29-56,
cyclophosphamide IV over 30-60 minutes on day 29, thioguanine PO on days 29-42, cytarabine IV
over 1-30 minutes or SC on days 29-32 and 36-39, methotrexate IT on days 29 and 36,
vincristine sulfate IV over 1 minute on days 43 and 50, and pegaspargase IV over 1-2 hours on
day 43 in the absence of disease progression or unexpected toxicity.
INTERIM MAINTENANCE WITH CAPIZZI METHOTREXATE: Patients receive imatinib mesylate PO QD or
BID on days 1-56, vincristine sulfate IV over 1 minute and methotrexate IV over 2-15 minutes
on days 1, 11, 21, 31, and 41, methotrexate IT on days 1 and 31, and pegaspargase IV over 1-2
hours on days 2 and 22 in the absence of disease progression or unexpected toxicity.
MAINTENANCE: Patients receive imatinib mesylate PO QD or BID on days 1-84, vincristine
sulfate IV over 1 minute on days 1, 29, and 57, prednisolone PO BID (or methylprednisolone IV
for course 1 and 2) on days 1-5, 29-33, and 57-61, mercaptopurine PO on days 1-84,
methotrexate PO QW, and methotrexate IT on day 1 (and day 29 for course 1 and 2). Courses
repeat every 84 days for up to 104 weeks from the start of Induction IA in the absence of
disease progression or unexpected toxicity.
ARM C:
CONSOLIDATION BLOCK 1: Patients receive imatinib mesylate, methotrexate, cytarabine,
therapeutic hydrocortisone, high dose methotrexate, vincristine sulfate, dexamethasone,
leucovorin calcium, high dose cytarabine, and pegaspargase as in Arm A Consolidation Block 1,
and filgrastim SC on day 7 in the absence of disease progression or unexpected toxicity.
CONSOLIDATION BLOCK 2: Patients receive imatinib mesylate, methotrexate, cytarabine,
therapeutic hydrocortisone, high dose methotrexate, dexamethasone, vincristine sulfate,
ifosfamide, leucovorin calcium, dexrazoxane hydrochloride, daunorubicin hydrochloride,
pegaspargase, and filgrastim as Arm A Consolidation Block 2 in the absence of disease
progression or unexpected toxicity.
CONSOLIDATION BLOCK 3: Patients receive imatinib mesylate, dexamethasone, etoposide,
methotrexate, cytarabine, therapeutic hydrocortisone, pegaspargase, and filgrastim as in Arm
A Consolidation Block 3, and high dose cytarabine IV over 3 hours on days 1-2 in the absence
of disease progression or unexpected toxicity.
HSCT: Patients undergo HSCT on day 0. Patients who do not proceed to HSCT receive Delayed
Intensification 1, Interim Maintenance, Delayed Intensification 2, and Maintenance as in Arm
A.
POST-HSCT: Patients receive imatinib mesylate PO QD or BID starting on days 56-365 in the in
the absence of disease progression or unexpected toxicity.
After completion of study treatment, patients are followed up every year for 3 years.
Inclusion Criteria:
- For patients enrolled on AALL08B1 or APEC14B1 (if open for ALL patients) prior to
enrollment on AALL1631, the required diagnostic bone marrow sample has been fulfilled
- For patients who have not previously enrolled on AALL08B1 or APEC14B1 (if open
for ALL patients) prior to enrollment on AALL1631, a baseline diagnostic sample
must be available to develop an MRD probe
- In addition, laboratory reports detailing evidence of BCR-ABL1 fusion must be
submitted for rapid central review within 72 hours of study enrollment
- Newly diagnosed de novo ALL (B-ALL or T-ALL) with definitive evidence of BCR-ABL1
fusion by karyotype, fluorescence in situ hybridization (FISH) and/or reverse
transcriptase (RT)-PCR
- Patient must have previously started induction therapy, which includes vincristine, a
corticosteroid, pegaspargase, with or without anthracycline, and/or other standard
cytotoxic chemotherapy
- Patient has not received more than 14 days of multiagent induction therapy beginning
with the first dose of vinCRIStine
- Patient may have started imatinib prior to study entry but has not received more than
14 days of imatinib
- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, or 2
- Direct bilirubin =< 2.0 mg/dL
- Shortening fraction of >= 27% by echocardiogram
- Ejection fraction of >= 50% by radionuclide angiogram or echocardiogram
- Corrected QT interval, QTc < 480 msec
- Note: Repeat echocardiogram is not required if echocardiogram was obtained within
21 days of study enrollment
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2
- Serum creatinine within normal limits based on age/gender, as follows:
- 1 to < 2 years: maximum serum creatinine 0.6 mg/dL (both male and female)
- 2 to < 6 years: maximum serum creatinine 0.8 mg/dL (both male and female)
- 6 to < 10 years: maximum serum creatinine 1 mg/dL (both male and female)
- 10 to < 13 years: maximum serum creatinine 1.2 mg/dL (both male and female)
- 13 to < 16 years: maximum serum creatinine 1.5 mg/dL (male), 1.4 mg/dL (female)
- >= 16 years: maximum serum creatinine 1.7 mg/dL (male), 1.4 mg/dL (female)
Exclusion Criteria:
- Known history of chronic myelogenous leukemia (CML)
- ALL developing after a previous cancer treated with cytotoxic chemotherapy
- Active, uncontrolled infection, or active systemic illness that requires ongoing
vasopressor support or mechanical ventilation
- Down syndrome
- Pregnancy and breast feeding
- Female patients who are pregnant; a pregnancy test is required for female
patients of childbearing potential
- Lactating females who plan to breastfeed their infants
- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation
- Patients with congenital long QT syndrome, history of ventricular arrhythmias or heart
block
- Prior treatment with dasatinib, or any BCR-ABL1 inhibitor other than imatinib
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
We found this trial at
119
sites
9040 Jackson Ave
Tacoma, Washington 98431
Tacoma, Washington 98431
(253) 968-1110
Principal Investigator: Melissa A. Forouhar
Phone: 253-968-0129
Madigan Army Medical Center Located on Joint Base Lewis-McChord, Madigan Army Medical Center comprises a...
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: John F. Kuttesch
Phone: 505-925-0366
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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4900 Mueller Boulevard
Austin, Texas 78723
Austin, Texas 78723
(512) 324-0000
Principal Investigator: Amy C. Fowler
Dell Children's Medical Center of Central Texas Welcome to Dell Children
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1600 7th Avenue
Birmingham, Alabama 35233
Birmingham, Alabama 35233
(205) 638-9100
Principal Investigator: Matthew A. Kutny
Children's Hospital of Alabama Children
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666 Elm Street
Buffalo, New York 14263
Buffalo, New York 14263
(716) 845-2300
Principal Investigator: Clare J. Twist
Phone: 800-767-9355
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1 South Prospect Street
Burlington, Vermont 05401
Burlington, Vermont 05401
802-656-8990
Principal Investigator: Jessica L. Heath
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Principal Investigator: Maureen M. O'Brien
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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11100 Euclid Avenue
Cleveland, Ohio 44106
Cleveland, Ohio 44106
(216) 844-1000
Principal Investigator: John J. Letterio
Phone: 216-844-5437
Rainbow Babies and Children's Hospital UH Rainbow Babies & Children’s Hospital is a 244-bed, full-service...
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700 Childrens Drive
Columbus, Ohio 43205
Columbus, Ohio 43205
(616) 722-2000
Principal Investigator: Mark A. Ranalli
Nationwide Children's Hospital At Nationwide Children’s, we are creating the future of pediatric health care....
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3533 South Alameda Street
Corpus Christi, Texas 78411
Corpus Christi, Texas 78411
(361) 694-5000
Principal Investigator: Nkechi I. Mba
Driscoll Children's Hospital Driscoll Children's Hospital was built because Clara Driscoll's will requested that a...
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7777 Forest Ln # C840
Dallas, Texas 75230
Dallas, Texas 75230
(972) 566-7000
Principal Investigator: Stanton C. Goldman
Phone: 972-566-5588
Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1500 E Duarte Rd
Duarte, California 91010
Duarte, California 91010
(626) 256-4673
Principal Investigator: Weili Sun
Phone: 800-826-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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100 Michigan Street Northeast
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
616.391.9000
Principal Investigator: Kathleen J. Yost
Helen DeVos Children's Hospital at Spectrum Health Helen DeVos Children's Hospital, located in Grand Rapids,...
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282 Washington St
Hartford, Connecticut 06106
Hartford, Connecticut 06106
(860) 545-9000
Principal Investigator: Michael S. Isakoff
Connecticut Children's Medical Center Connecticut Children’s Medical Center is a nationally recognized, 187-bed not-for-profit children’s...
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2500 N State St
Jackson, Mississippi 39216
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Anderson (Andy) B. Collier
Phone: 601-815-6700
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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524 South Park Street
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
(269) 341-7654
Principal Investigator: Kathleen J. Yost
Phone: 616-391-1230
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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2401 Gillham Rd
Kansas City, Missouri 64108
Kansas City, Missouri 64108
(816) 234-3000
Principal Investigator: Keith J. August
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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1800 West Charleston Boulevard
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
(702) 383-2000
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
University Medical Center of Southern Nevada University Medical Center is dedicated to providing the highest...
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4650 Sunset Blvd
Los Angeles, California 90027
Los Angeles, California 90027
(323) 660-2450
Principal Investigator: Leo Mascarenhas
Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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4015 22nd Place
Lubbock, Texas 79410
Lubbock, Texas 79410
806-725-0000
Principal Investigator: Kishor M. Bhende
Covenant Children's Hospital Every child is different. And when they're sick or injured, they deserve...
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9300 Valley Children's Pl
Madera, California 93720
Madera, California 93720
(559) 353-3000
Principal Investigator: Vonda L. Crouse
Children's Hospital Central California The Children's Hospital Central California is a not-for-profit, state-of-the-art children’s hospital...
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601 Children's Lane
Norfolk, Virginia 23507
Norfolk, Virginia 23507
(757) 668-7000
Principal Investigator: Eric J. Lowe
Children's Hospital of The King's Daughters Children
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747 52nd St
Oakland, California 94609
Oakland, California 94609
(510) 428-3000
Principal Investigator: Carla B. Golden
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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1201 W La Veta Ave
Orange, California 92868
Orange, California 92868
(714) 997-3000
Principal Investigator: Elyssa M. Rubin
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Principal Investigator: Susan R. Rheingold
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
412-692-5325
Principal Investigator: Jean M. Tersak
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Principal Investigator: Bill H. Chang
Phone: 503-494-1080
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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60 Crittenden Blvd # 70
Rochester, New York 14642
Rochester, New York 14642
(585) 275-2121
Principal Investigator: Jeffrey R. Andolina
Phone: 585-275-5830
University of Rochester The University of Rochester is one of the country's top-tier research universities....
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7700 Floyd Curl Dr
San Antonio, Texas 78229
San Antonio, Texas 78229
(210) 575-7000
Principal Investigator: Vinod K. Gidvani-Diaz
Methodist Children's Hospital of South Texas Methodist Children
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3020 Childrens way
San Diego, California 92123
San Diego, California 92123
(858) 576-1700
Principal Investigator: William D. Roberts
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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1600 Rockland Road
Wilmington, Delaware 19803
Wilmington, Delaware 19803
(302) 651-4200
Principal Investigator: Emi H. Caywood
Phone: 302-651-6884
Alfred I. duPont Hospital for Children Nemours began more than 70 years ago with the...
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Akron, Ohio 44308
Principal Investigator: Steven J. Kuerbitz
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Allentown, Pennsylvania 18103
Principal Investigator: Lydia A. Boateng
Phone: 734-712-3671
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1540 East Hospital Drive
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(877) 475-6688
Principal Investigator: Rajen Mody
C S Mott Children's Hospital Behind the doors of C.S. Mott Children's Hospital there exist...
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Asheville, North Carolina 28801
Principal Investigator: Douglas J. Scothorn
Phone: 828-213-4150
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Atlanta, Georgia 30322
Principal Investigator: Daniel J. Bergsagel
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13123 E 16th Ave
Aurora, Colorado 80045
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Kelly W. Maloney
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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2401 W Belvedere Ave
Baltimore, Maryland 21215
Baltimore, Maryland 21215
(410) 601-9000
Principal Investigator: Jason M. Fixler
Phone: 410-601-6120
Sinai Hospital of Baltimore Sinai Hospital of Baltimore provides a broad array of high-quality, cost-effective...
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401 North Broadway
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Patrick A. Brown
Phone: 410-955-8804
Johns Hopkins University-Sidney Kimmel Cancer Center The name Johns Hopkins has become synonymous with excellence...
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450 Brookline Ave
Boston, Massachusetts 2215
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Lewis B. Silverman
Phone: 877-442-3324
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, Massachusetts 02111
Principal Investigator: Michael J. Kelly
Phone: 617-636-5535
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55 Fruit St
Boston, Massachusetts 02114
Boston, Massachusetts 02114
(617) 724-4000
Principal Investigator: Lewis B. Silverman
Phone: 877-726-5130
Massachusetts General Hospital Cancer Center An integral part of one of the world
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Bronx, New York 10467
Principal Investigator: Lisa Gennarini
Phone: 718-379-6866
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Chapel Hill, North Carolina 27599
Principal Investigator: Stuart H. Gold
Phone: 877-668-0683
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Charlotte, North Carolina 28204
Principal Investigator: Jessica A. Bell
Phone: 704-384-5369
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2049 E 100th St
Cleveland, Ohio 44106
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Aron Flagg
Phone: 866-223-8100
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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5 Richland Medical Park Dr
Columbia, South Carolina 29203
Columbia, South Carolina 29203
(803) 434-7000
Principal Investigator: Stuart L. Cramer
Phone: 803-434-3680
Palmetto Health Richland Palmetto Health Richland, originally founded in 1892 as Columbia Hospital, has a...
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Dallas, Texas 75390
Principal Investigator: Tamra L. Slone
Phone: 214-648-7097
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Denver, Colorado 80218
Principal Investigator: Jennifer J. Clark
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9333 Imperial Highway
Downey, California 90242
Downey, California 90242
Principal Investigator: Robert M. Cooper
Phone: 626-564-3455
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Fort Myers, Florida 33908
Principal Investigator: Emad K. Salman
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801 7th Avenue
Fort Worth, Texas 76104
Fort Worth, Texas 76104
(682) 885-4000
Principal Investigator: Kenneth M. Heym
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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1600 Southwest Archer Road
Gainesville, Florida 32610
Gainesville, Florida 32610
Principal Investigator: William B. Slayton
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835 S Van Buren St
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Principal Investigator: Catherine A. Long
Phone: 920-433-8889
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1001 E 5th St
Greenville, North Carolina 27858
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: Andrea R. Whitfield
Phone: 252-744-2391
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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900 West Faris Rd.
Greenville, South Carolina 29605
Greenville, South Carolina 29605
(864)455-8898
Principal Investigator: Nichole L. Bryant
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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30 Prospect Ave
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-2000
Principal Investigator: Burton E. Appel
Phone: 201-996-2879
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hollywood, Florida 33021
Principal Investigator: Iftikhar Hanif
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1319 Punahou St
Honolulu, Hawaii 96826
Honolulu, Hawaii 96826
(808) 983-6000
Principal Investigator: Wade T. Kyono
Phone: 808-983-6090
Kapiolani Medical Center for Women and Children Hawai‘i Pacific Health is an integrated health care...
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Houston, Texas 77030
Principal Investigator: Rachel E. Rau
Phone: 713-798-1354
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Houston, Texas 77030
Principal Investigator: Najat C. Daw
Phone: 877-312-3961
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Kamnesh R. Pradhan
Phone: 800-248-1199
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Indianapolis, Indiana 46260
Principal Investigator: Bassem I. Razzouk
Phone: 317-338-2194
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Iowa City, Iowa 52242
Principal Investigator: Mariko Sato
Phone: 800-237-1225
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Jacksonville, Florida 32207
Principal Investigator: Emi H. Caywood
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2018 W Clinch Ave
Knoxville, Tennessee 37916
Knoxville, Tennessee 37916
(865) 541-8000
Principal Investigator: Ray C. Pais
Phone: 865-541-8266
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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Las Vegas, Nevada 89109
Principal Investigator: Alan K. Ikeda
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Las Vegas, Nevada 89109
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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Las Vegas, Nevada 89144
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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1 Medical Center Dr
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 650-5000
Principal Investigator: Sara Chaffee
Phone: 800-639-6918
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lexington, Kentucky
Principal Investigator: Vlad C. Radulescu
Phone: 859-257-3379
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1 Children's Way
Little Rock, Arkansas 72202
Little Rock, Arkansas 72202
(501) 364-1100
Principal Investigator: David L. Becton
Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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11234 Anderson St
Loma Linda, California 92354
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Albert Kheradpour
Phone: 909-558-3375
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Principal Investigator: Kenneth B. De Santes
Phone: 800-622-8922
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Marshfield, Wisconsin 54449
Principal Investigator: Michael J. McManus
Phone: 800-782-8581
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Miami, Florida 33136
Principal Investigator: Julio C. Barredo
Phone: 305-243-2647
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9000 W Wisconsin Ave #270
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
(414) 266-2000
Principal Investigator: Michael J. Burke
Phone: 414-955-4727
Children's Hospital of Wisconsin Nothing matters more than our children. At Children's Hospital of Wisconsin,...
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2525 Chicago Ave
Minneapolis, Minnesota 55404
Minneapolis, Minnesota 55404
(612) 813-6000
Principal Investigator: Michael K. Richards
Children's Hospitals and Clinics of Minnesota - Minneapolis Children's Hospitals and Clinics of Minnesota is...
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Minneapolis, Minnesota 55455
Principal Investigator: Peter M. Gordon
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Morgantown, West Virginia 26505
Principal Investigator: Stephan R. Paul
Phone: 304-293-7374
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Morristown, New Jersey 07962
Principal Investigator: Steven L. Halpern
Phone: 973-971-5900
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Nashville, Tennessee 37203
Principal Investigator: Haydar A. Frangoul
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New Orleans, Louisiana 70121
Principal Investigator: Craig Lotterman
Phone: 504-703-8712
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Oak Lawn, Illinois 60453
Principal Investigator: Rebecca E. McFall
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Oakland, California 94611
Principal Investigator: Steven K. Bergstrom
Phone: 877-642-4691
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940 NE 13th St
Oklahoma City, Oklahoma 73190
Oklahoma City, Oklahoma 73190
(405) 271-6458
Principal Investigator: Rene Y. McNall-Knapp
Phone: 405-271-8777
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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8200 Dodge St
Omaha, Nebraska 68114
Omaha, Nebraska 68114
(402) 955-5400
Principal Investigator: Minnie Abromowitch
Children's Hospital and Medical Center of Omaha Children's Hospital & Medical Center has a rich...
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Emile St
Omaha, Nebraska 68198
Omaha, Nebraska 68198
(402) 559-4000
Principal Investigator: Minnie Abromowitch
Phone: 402-559-6941
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Orlando, Florida 32803
Principal Investigator: Fouad M. Hajjar
Phone: 407-303-2090
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Orlando, Florida 32806
Principal Investigator: Vincent F. Giusti
Phone: 321-843-2584
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13535 Nemours Parkway
Orlando, Florida 32827
Orlando, Florida 32827
(407) 567-4000
Principal Investigator: Emi H. Caywood
Nemours Children's Hospital Nemours Children's Hospital in Orlando brings pediatric specialty care never before offered...
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725 Welch Rd
Palo Alto, California 94304
Palo Alto, California 94304
(650) 497-8000
Principal Investigator: Sheri L. Spunt
Lucile Packard Children's Hospital Stanford University Stanford Children's Health is the only network in the...
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Park Ridge, Illinois 60068
Principal Investigator: Caroline Y. Hu
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Philadelphia, Pennsylvania 19104
Principal Investigator: Lewis B. Silverman
Phone: 877-442-3324
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3601 A St
Philadelphia, Pennsylvania 19134
Philadelphia, Pennsylvania 19134
(215) 427-5000
Principal Investigator: Gregory E. Halligan
Saint Christopher's Hospital for Children St. Christopher's Hospital for Children offers a wide range of...
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1919 E Thomas Rd
Phoenix, Arizona 85006
Phoenix, Arizona 85006
(602) 933-1000
Principal Investigator: Jessica Boklan
Phone: 602-546-0920
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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