Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia



Status:Recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 39
Updated:2/23/2019
Start Date:June 1, 2017
End Date:August 2024
Contact:Daniel J. DeAngelo, MD, PhD
Email:daniel_deangelo@dfci.harvard.edu
Phone:617-632-2645

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A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti-CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18-39 Years) With Newly Diagnosed Precursor B-Cell ALL

This partially randomized phase III trial studies the side effects of inotuzumab ozogamicin
and how well it works when given with frontline chemotherapy in treating patients with newly
diagnosed B acute lymphoblastic leukemia. Monoclonal antibodies, such as inotuzumab
ozogamicin, may block cancer growth in different ways by targeting certain cells. Drugs used
in chemotherapy work in different ways to stop the growth of tumor cells, either by killing
the cells, by stopping them from dividing, or by stopping them from spreading. Giving
inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute
lymphoblastic leukemia.

PRIMARY OBJECTIVES:

I. To confirm tolerability of the combination regimen with the addition of inotuzumab
ozogamicin to the pediatric-inspired regimen of cancer and leukemia group B (CALGB) 10403.

II. To determine whether the addition of inotuzumab ozogamicin significantly improves the
event-free survival (EFS) in patients who achieve an induction response achieved with the
pediatric-inspired regimen of CALGB 10403, without censoring for transplant. (Phase III)

SECONDARY OBJECTIVES:

I. To determine the impact of inotuzumab ozogamicin on disease-free (DFS) and overall
survival (OS) in patients who achieve an induction response.

II. To determine whether the addition of inotuzumab ozogamicin significantly improves the
event-free survival (EFS) in patients who achieve an induction response achieved with the
pediatric-inspired regimen of CALGB 10403, with censoring for transplant.

III. To determine the impact of inotuzumab ozogamicin on minimal residual disease (MRD) and
correlate this with the EFS, DFS and OS.

IV. To determine the prognosis based on patients' low-density array (LDA) gene signature in
terms of EFS, DFS, and OS after treatment with or without inotuzumab ozogamicin when added to
the C10403 backbone regimen.

V. To evaluate the toxicity and tolerability of the addition of inotuzumab ozogamicin to the
pediatric-inspired regimen of CALGB 10403.

TERTIARY OBJECTIVES:

I. To assess both the correlation of MRD post-induction and at sequential timepoints with LDA
signature.

II. To evaluate the influence of MRD status (detectable vs. not and as a continuous measure)
in relation to EFS both in the univariate setting as well as adjusting for other clinical
features including initial white blood cell (WBC), ethnicity, gender and age at diagnosis.

III. To evaluate the impact of inotuzumab ozogamicin (inotuzumab) on the kinetics of MRD
during treatment with inotuzumab in patients randomized to the experimental treatment arm.

IV. To perform genomic analyses to identify and evaluate the incidence and clinical
significance of recurring novel fusion genes including those associated with the
BCR-ABL1-like signature and to correlate with MRD status, CR rate, EFS and OS.

V. To assess whether rs4958351 is correlated with L-asp allergic reaction in the adolescent
and young adult (AYA) population.

VI. To assess the incidence of inherited genetic variants in the GR1A1, CEP72, CPA2, TPMT,
NUDT15, GRIN3A, GRIK1, and other genes (which can be found using a whole genome association
study [GWAS]), are correlated with increased rates of target toxicities including peripheral
neuropathy, hepatotoxicity, pancreatitis, myelosuppression, neurotoxicity, thrombosis, and
osteonecrosis, and correlate with treatment discontinuation and other clinical response
parameters including complete response (CR) rate, EFS, and OS.

VII. To evaluate asparaginase pharmacokinetics in adolescents and young adults, and
investigate its correlation with toxicities and treatment outcomes.

VIII. To investigate the effect of anti-polyethylene glycol (PEG) and anti-agouti signaling
protein (ASP) antibodies (PEG-ASP) on ASP enzyme activity.

IX. To measure adherence to oral 6 mercaptopurine (MP) and methotrexate in AYAs with acute
lymphoblastic leukemia (ALL) and to examine sociodemographic and behavioral determinants of
adherence.

X. To determine the impact of adherence on risk of relapse among AYAs with ALL.

OUTLINE:

COURSE I (REMISSION INDUCTION THERAPY): All patients receive allopurinol orally (PO) once
daily until peripheral blasts and extramedullary disease are reduced and cytarabine
intrathecally (IT) over 1 minute on day 1. Patients also receive daunorubicin hydrochloride
intravenously (IV) and vincristine sulfate IV on days 1, 8, 15 and 22, dexamethasone PO or IV
twice daily (BID) on days 1-7 and 15-21, pegylated recombinant L-asparaginase erwinia
chrysanthemi IV on day 4, 5, or 6, and methotrexate IT over 1 minute on days 8 and 29.
Patients with central nervous system (CNS) 3 disease receive methotrexate IT over 1 minute
also on days 15 and 22. All patients then undergo bone marrow aspirate and biopsy on day 29.

Patients with response to remission induction therapy are randomized to 1 of 2 arms. Patients
with no response are omitted from the study.

ARM I:

COURSE II (REMISSION CONSOLIDATION CHEMOTHERAPY): Patients receive cyclophosphamide IV on
days 1 and 29, cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on
days 1-14 and 29-42, and vincristine sulfate IV on days 15, 22, 43, and 50. Patients also
receive pegylated recombinant L- asparaginase erwinia chrysanthemi IV on days 15 and 43, and
methotrexate IT on days 1, 8, 15, and 22. Patients with CNS3 receive methotrexate IT only on
days 1 and 8. CD20 positive (+) patients receive rituximab IV on days 1, 8, 29, and 36.
Patients then undergo bone marrow aspirate and biopsy on day 56.

COURSE III (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV on
days 1, 11, 21, 31, and 41, methotrexate IV and IT on days 1, 11, 21, 31, and 41, and
pegylated recombinant L- asparaginase erwinia chrysanthemi IV on days 2 and 22. CD20+
patients receive rituximab IV on days 1 and 11.

COURSE IV (DELAYED INTENSIFICATION): Patients receive vincristine sulfate IV on days 1, 8,
15, 43, and 50, dexamethasone PO or IV BID on days 1-7 and 15-21, doxorubicin IV on days 1,
8, and 15, and pegylated recombinant L- asparaginase erwinia chrysanthemi IV on day 4, 5, or
6 and day 43. Patients also receive cyclophosphamide IV on day 29, cytarabine IV or SC on
days 29-32 and 36-39, thioguanine PO on days 29-42 and methotrexate IT on days 1, 29, and 36.
CD20+ patients receive rituximab IV on days 1 and 8. Patients then undergo bone marrow
aspirate and biopsy on day 50.

COURSE V (MAINTENANCE THERAPY): Patients receive vincristine sulfate IV on days 1, 29, and
57, dexamethasone PO or IV BID on days 1-5, 29-33, and 57-61, and mercaptopurine PO on days
1-84. Patients also receive methotrexate IT or PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64,
71, and 78. Treatment repeats every 12 weeks for up to 3 years in the absence of disease
progression or unacceptable toxicity.

ARM II: Patients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone
marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 courses in
the absence of disease progression or unacceptable toxicity. Patients also receive remission
consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and
maintenance therapy as in Arm I.

After completion of study treatment, patients are followed up every month for the first year,
every 2 months for the second year, every 3 months for the third year, and every 6 months for
the fourth through tenth year.

Inclusion Criteria:

REGISTRATION ELIGIBILITY CRITERIA (STEP 1)

- Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO
criteria) are eligible. Patients with Burkitt type ALL are NOT eligible

- Patients who have BCR-ABL fusion transcript determined by fluorescence in situ
hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or
t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for
enrollment on studies that incorporate imatinib during induction; please note: flow
cytometry is to be performed at the local reference lab and must include assessment of
CD20 and CD22 positivity, as well as CD29 and CD22 anti-positivity

- No prior therapy except for limited treatment (< 7 days) with corticosteroids or
hydroxyurea and a single dose of intrathecal cytarabine

- No prior therapy for acute leukemia except emergency therapy (corticosteroids or
hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due
to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange
transfusion is recommended to reduce the WBC

- Single-dose intrathecal cytarabine is allowed prior to registration or prior to
initiation of systematic therapy for patient convenience; systemic chemotherapy must
begin within 72 hours of this intrathecal therapy

- Patients receiving prior steroid therapy are eligible for study; the dose and duration
of previous steroid therapy should be carefully documented on case report forms

- Not pregnant and not nursing; for women of childbearing potential only, a negative
urine or serum pregnancy test done =< 7 days prior to registration is required

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Patients with down syndrome are excluded from this study

- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x upper limit of
normal (ULN), unless suspected leukemic involvement of the liver

- Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic
involvement of the liver

- Calculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-Gault

RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2)

- Completion of remission induction therapy

- Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater
than 25% lymphoblasts) will not be eligible to be randomized

- Rating: M0, M1; Blast Cells (%): 0-5.0

- Rating: M2; Blast Cells (%): 5.1-25.0

- Rating: M3; Blast Cells (%): > 25-50

- Rating: M4; Blast Cells (%): > 50.0

- The term "blast cell" includes any cell that cannot be classified as a more
mature normal element, and includes "leukemic cells," pathologic lymphocytes, and
stem cells

- No ascites, effusions or significant edema

- Absolute neutrophil count (ANC) >= 1,000/mm^3

- Platelet count >= 100,000/mm^3

- Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known
Gilbert's syndrome

- Aspartate aminotransferase (AST) =< 8 x upper limit of normal (ULN)

- Completion of first 12 weeks (12+ weeks) of maintenance therapy (Course V)

- Patient has at least 24 weeks (24+ weeks) remaining before end of maintenance therapy
(Course V)

- Patient is in complete continuous first remission at entry into A041501-HO1

- Patient is receiving oral anti-metabolite chemotherapy during the maintenance phase of
therapy; treatment plan must call for the following doses of antimetabolites: 6MP 75
mg/m2/day orally; methotrexate (MTX) 20 mg/m2/week orally (modification of 6 MP or MTX
dosing based on laboratory or clinical parameters is acceptable)

- Patient is able and willing to use the Medication Event Monitoring System (MEMS)
TrackCap (e.g. not using a pillbox)
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Edina, MN
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Evanston, Illinois 60201
Principal Investigator: Lynne S. Kaminer
Phone: 847-570-2109
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Evanston, IL
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1717 13th St
Everett, Washington 98201
(425) 297-5500
Principal Investigator: Alison K. Conlin
Phone: 425-261-3529
Providence Regional Cancer Partnership Founded in 2007, the Providence Regional Cancer Partnership is the result...
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from
Everett, WA
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Fargo, North Dakota 58103
Principal Investigator: Andrea M. Watson
Phone: 218-786-3308
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Fargo, ND
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Fergus Falls, Minnesota 56537
Principal Investigator: Andrea M. Watson
Phone: 218-786-3308
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Fergus Falls, MN
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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Flint, MI
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900 Hilligoss Boulevard Southeast
Fosston, Minnesota 56542
Principal Investigator: Andrea M. Watson
Phone: 701-364-6272
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Fosston, MN
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Fresno, California 93720
Principal Investigator: Jennifer M. Suga
Phone: 877-642-4691
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Fresno, CA
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550 Osborne Rd NE
Fridley, Minnesota 55432
(763) 236-5000
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Unity Hospital Unity Hospital is one of the Twin Cities
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Fridley, MN
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Fruitland, Idaho 83619
Principal Investigator: Alison K. Conlin
Phone: 773-702-9171
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Fruitland, ID
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Glenview, Illinois 60026
Principal Investigator: Lynne S. Kaminer
Phone: 847-570-2109
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Glenview, IL
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1117 29th St S
Great Falls, Montana 59405
(406) 771-7300
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Benefis Healthcare- Sletten Cancer Institute Benefis Hospitals has 516 beds at its two campuses (that...
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Great Falls, MT
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
Principal Investigator: Jeffrey K. Giguere
Phone: 773-702-9171
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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from
Greenville, SC
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Greenville, South Carolina 29605
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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Greenville, SC
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Greenville, South Carolina 29615
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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Greenville, SC
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Greenville, South Carolina 29607
Principal Investigator: Howland E. Crosswell
Phone: 864-603-6213
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Greenville, SC
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1 St. Francis Drive
Greenville, South Carolina 29601
864-255-1000
Principal Investigator: Howland E. Crosswell
Phone: 864-603-6213
Saint Francis Hospital This 245-bed, all-private-room facility is located near downtown Greenville, South Carolina. Formerly...
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Greenville, SC
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Greer, South Carolina 29650
Principal Investigator: Jeffrey K. Giguere
Phone: 864-241-6251
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from
Greer, SC
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Hartford, Connecticut 06105
Principal Investigator: Nikolai A. Podoltsev
Phone: 203-785-5702
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from
Hartford, CT
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730 East 34th Street
Hibbing, Minnesota 55746
Principal Investigator: Andrea M. Watson
Phone: 218-786-3308
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from
Hibbing, MN
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Highland Park, Illinois 60035
Principal Investigator: Lynne S. Kaminer
Phone: 847-570-2109
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Highland Park, IL
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Iowa City, Iowa 52242
Principal Investigator: Thomas H. Carter
Phone: 800-237-1225
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Iowa City, IA
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Issaquah, Washington 98029
Principal Investigator: Alison K. Conlin
Phone: 206-215-3086
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Issaquah, WA
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2430 20th Street Southwest
Jamestown, North Dakota 58401
Principal Investigator: Andrea M. Watson
Phone: 701-364-6272
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Jamestown, ND
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1102 W 32nd St
Joplin, Missouri 64804
(417) 347-1111
Principal Investigator: Jay W. Carlson
Phone: 417-347-4030
Freeman Health System Freeman in Joplin, Missouri, is a 485-bed, three-hospital system providing comprehensive healthcare...
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Joplin, MO
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310 Sunnyview Ln
Kalispell, Montana 59901
(406) 752-5111
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Kalispell Regional Medical Center Nestled in the beautiful Flathead Valley of Northwestern Montana, Kalispell Regional...
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Kalispell, MT
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Kansas City, Kansas 66160
Principal Investigator: Ajoy L. Dias
Phone: 913-945-7552
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Kansas City, KS
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Kennewick, Washington 99336
Principal Investigator: Alison K. Conlin
Phone: 509-783-4637
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Kennewick, WA
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Lacey, Washington 98503
Principal Investigator: Alison K. Conlin
Phone: 360-412-8958
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Lacey, WA
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Lake Forest, Illinois 60045
Principal Investigator: Shira N. Dinner
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Lake Forest, IL
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450 Lakeville Road
Lake Success, New York 11042
Principal Investigator: Cristina M. Ghiuzeli
Phone: 516-734-8896
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Lake Success, NY
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1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-1000
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
Sparrow Hospital Sparrow has grown to become the region's largest health system, and its diverse...
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Lansing, MI
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325 Maine Street
Lawrence, Kansas 66044
(785) 505-5000
Principal Investigator: Shaker R. Dakhil
Phone: 316-268-5374
Lawrence Memorial Hospital Lawrence Memorial Hospital (LMH), in collaboration with its medical staff, is dedicated...
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Lawrence, KS
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Livonia, Michigan 48154
Principal Investigator: Tareq Al Baghdadi
Phone: 734-712-3671
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Livonia, MI
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