Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia



Status:Recruiting
Conditions:Other Indications, Blood Cancer
Therapuetic Areas:Oncology, Other
Healthy:No
Age Range:1 - 30
Updated:2/17/2019
Start Date:December 8, 2014

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Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL)

This randomized phase III trial studies how well blinatumomab works compared with standard
combination chemotherapy in treating patients with B-cell acute lymphoblastic leukemia that
has returned after a period of improvement (relapsed). Monoclonal antibodies, such as
blinatumomab, may interfere with the ability of tumor cells to grow and spread. It is not yet
known whether standard combination chemotherapy is more effective than blinatumomab in
treating relapsed B-cell acute lymphoblastic leukemia.

PRIMARY OBJECTIVES:

I. To compare disease free survival (DFS) of high-risk (HR) and intermediate-risk (IR)
relapse B-cell acute lymphoblastic leukemia (B-ALL) patients who are randomized following
induction block 1 chemotherapy to receive either two intensive chemotherapy blocks or two
5-week blocks of blinatumomab (HR/IR randomization).

II. To compare the DFS of low risk (LR) relapse B-ALL patients who are randomized following
block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab
(LR randomization).

SECONDARY OBJECTIVES:

I. To compare overall survival (OS) of HR and IR relapse B-ALL patients who are randomized
following induction block 1 chemotherapy to receive either two intensive chemotherapy blocks
or two 5-week blocks of blinatumomab (HR/IR randomization).

II. To compare OS of LR relapse B-ALL patients who are randomized following block 1
chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR
randomization).

TERTIARY OBJECTIVES:

I. To compare the rates of minimal residual disease (MRD) >= 0.01% at the end of block 2 and
block 3 for HR and IR relapse B-ALL patients in HR/IR randomization.

II. To estimate, for treatment failure (TF) patients not previously receiving blinatumomab,
the hematologic complete remission rate (CR), rate of MRD < 0.01%, and proportion able to
proceed to hematopoietic stem cell transplant (HSCT) in CR after treatment with blinatumomab.

III. To assess the feasibility and safety of rapid taper of immune suppression for the subset
of HSCT patients with MRD >= 0.01% pre- and/or post-HSCT with no acute graft versus host
disease (aGVHD).

IV. To evaluate blinatumomab pharmacokinetics (PK) and explore exposure-response
relationships for measures of safety and effectiveness.

OUTLINE:

All patients receive Block 1 over 4 weeks.

BLOCK 1: Patients receive dexamethasone orally (PO) twice daily (BID) or intravenously (IV)
on days 1-5 and 15-19; vincristine sulfate IV over 1 minute on days 1, 8, 15, and 22;
pegaspargase IV over 1-2 hours on days 3 and 17; and mitoxantrone hydrochloride IV over 15-30
minutes on days 1-2. Patients with central nervous system (CNS) 1 or CNS2 also receive
methotrexate intrathecally (IT) on days 1 and 8. Patients with CNS3 or isolated CNS relapse
also receive methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1, 8, 15, and 22.
High risk and intermediate risk patients are then assigned to randomization R1. Low risk
patients are assigned to randomization R2.

RANDOMIZATION R1 (HR and IR patients): Patients are randomized to 1 of 2 treatment arms.

ARM A: Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, and then undergo
allogeneic HSCT.

ARM B: Patients receive Blinatumomab Block 1 over 5 weeks, Blinatumomab Block 2 over 5 weeks,
and then undergo allogeneic HSCT.

RANDOMIZATION R2 (LR patients): Patients are then randomized to 1 of 2 treatment arms.

ARM C: Patients receive Block 2 over 4 weeks, Block 3 over 4 weeks, Continuation 1 over 8
weeks, Continuation 2 over 8 weeks, and then Maintenance.

ARM D: Patients receive Block 2 over 4 weeks, Blinatumomab Block 2 over 5 weeks, Continuation
1 over 8 weeks, Blinatumomab Block 3 over 5 weeks, Continuation 2 over 8 weeks, Blinatumomab
Block 3 over 5 weeks, and then Maintenance.

BLOCK 2: Patients receive dexamethasone PO BID or IV on days 1-5; vincristine sulfate IV over
1 minute on day 1; methotrexate IV over 36 hours on day 8; leucovorin calcium IV or PO on
days 10-11; pegaspargase IV over 1-2 hours on day 9 or 10; cyclophosphamide IV over 15-30
minutes on days 15-19; and etoposide IV over 1-2 hours on days 15-19. Patients with CNS1 or
CNS2 also receive methotrexate IT on day 8. Patients with CNS3 also receive methotrexate IT,
hydrocortisone IT, and cytarabine IT on days 8 and 22.

BLOCK 3: Patients receive dexamethasone PO BID or IV on days 1-5; vincristine sulfate IV over
1 minute on day 1; cytarabine IV over 3 hours every 12 hours on days 1, 2, 8, and 9;
asparaginase intramuscularly (IM) or IV over 1 hour on days 2, 4, 9, 11, and 23; methotrexate
IT on day 1 and IV over 36 hours on day 22; leucovorin calcium PO or IV on days 24-25.
Patients with CNS1 or CNS2 also receive methotrexate IT on day 22. Patients with CNS3 also
receive methotrexate IT, hydrocortisone IT, and cytarabine IT on day 22.

BLINATUMOMAB BLOCK 1: Patients dexamethasone PO or IV on day 1 and blinatumomab IV
continuously on days 1-28. Patients with CNS1 or CNS2 also receive methotrexate IT on days 15
and 29. Patients with CNS3 also receive methotrexate IT, hydrocortisone IT, and cytarabine IT
on days 15 and 29.

BLINATUMOMAB BLOCK 2: Patients blinatumomab IV continuously on days 1-28. Patients with CNS1
or CNS2 also receive methotrexate IT on days 8 and 29. Patients with CNS3 also receive
methotrexate IT, hydrocortisone IT, and cytarabine IT on days 8 and 29.

BLINATUMOMAB BLOCK 3: Patients blinatumomab IV continuously on days 1-28 and dexamethasone PO
or IV on day 1.

CONTINUATION 1 & 2: Patients receive dexamethasone PO BID or IV on days 1-5; vincristine
sulfate IV over 1 minute on day 1; mercaptopurine tablet PO on days 1-42; methotrexate PO on
days 8, 15, 29, and 36; leucovorin calcium PO or IV on day 24-25 (patients with CNS1, CNS2,
or CNS3); cyclophosphamide IV over 15-30 minutes on days 43 and 50; etoposide IV over 1-2
hours on days 43 and 50; thioguanine PO once daily on days 43-49; and cytarabine IV over 1-30
minutes or subcutaneously (SC) on days 44-47 and 51-54. Patients with CNS1 or CNS2 also
receive methotrexate IT on days 1 and 43. Patients with CNS3 also receive methotrexate IT,
hydrocortisone IT, and cytarabine IT on days 1 and 43; methotrexate PO every 6 hours on day
22; and methotrexate IV over 36 hours on day 22.

MAINTENANCE: Patients receive dexamethasone PO BID or IV on days 1-5, 29-33, and 57-61;
vincristine sulfate IV over 1 minute on days 1, 29, and 57; mercaptopurine tablet PO on days
1-84; and methotrexate PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Patients
with CNS1 or CNS2 also receive methotrexate IT on day 1. Patients with CNS3 also receive
methotrexate IT, hydrocortisone IT, and cytarabine IT on day 1. Courses repeat every 12 weeks
for up to 2 years since the beginning of treatment in the absence of disease progression or
unacceptable toxicity.

After completion of study treatment, patients are followed up annually for 10 years.

Inclusion Criteria:

- First relapse of B-ALL, allowable sites of disease include isolated bone marrow,
combined bone marrow and CNS and/or testicular, and isolated CNS and/or testicular;
extramedullary sites are limited to the CNS and testicles

- No waiting period for patients who relapse while receiving standard maintenance
therapy

- Patients who relapse on frontline therapy in phases other than maintenance must have
fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy,
or radiotherapy prior to entering this study

- Cytotoxic therapy: at least 14 days since the completion of cytotoxic therapy with the
exception of hydroxyurea, which is permitted up to 24 hours prior to the start of
protocol therapy, or maintenance chemotherapy, or intrathecal chemotherapy
(methotrexate strongly preferred) administered at the time of the required diagnostic
lumbar puncture to establish baseline CNS status

- Biologic (anti-neoplastic) agent: at least 7 days since the completion of therapy with
a biologic agent; for agents that have known adverse events occurring beyond 7 days
after administration, this period must be extended beyond the time during which
adverse events are known to occur

- Stem cell transplant or rescue: patient has not had a prior stem cell transplant or
rescue

- Patient has not had prior treatment with blinatumomab

- With the exception of intrathecal chemotherapy (methotrexate strongly preferred;
cytarabine is permissible) administered at the time of the required diagnostic lumbar
puncture to establish baseline CNS status, patient has not received prior
relapse-directed therapy (i.e., this protocol is intended as the INITIAL treatment of
first relapse)

- Patients must have a performance status corresponding to Eastern Cooperative Oncology
Group (ECOG) scores of 0, 1, or 2; use Karnofsky for patients > 16 years of age and
Lansky for patients =< 16 years of age

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows:

- 1 to < 2 years: =< 0.6 mg/dL

- 2 to < 6 years: =< 0.8 mg/dL

- 6 to < 10 years: =< 1 mg/dL

- 10 to < 13 years: =< 1.2 mg/dL

- 13 to < 16 years: =< 1.5 mg/dL (males) and =< 1.4 mg/dL (females)

- >= 16 years: =< 1.7 mg/dL (males) and =< 1.4 mg/dL (females)

- Direct bilirubin < 3.0 mg/dL

- Shortening fraction of >= 27% by echocardiogram, or

- Ejection fraction of >= 50% by radionuclide angiogram

- All patients and/or their parent or legal guardian 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

Exclusion Criteria:

- Patients with Philadelphia chromosome positive/breakpoint cluster region protein
(BCR)-Abelson murine leukemia viral oncogene homolog 1 (ABL1)+ ALL are not eligible

- Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia are not eligible

- Patients with T-lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (T-LL) are not
eligible

- Patients with B-lymphoblastic lymphoma (B-LL) are not eligible

- Patients with known optic nerve and/or retinal involvement are not eligible; patients
who are presenting with visual disturbances should have an ophthalmologic exam and, if
indicated, a magnetic resonance imaging (MRI) to determine optic nerve or retinal
involvement

- Patients known to have one of the following concomitant genetic syndromes: Down
syndrome, Bloom syndrome, ataxia-telangiectasia, Fanconi anemia, Kostmann syndrome,
Shwachman syndrome or any other known bone marrow failure syndrome

- Patients with known human immunodeficiency virus (HIV) infection

- Patients with known allergy to mitoxantrone, cytarabine, or both etoposide and
etoposide phosphate (Etopophos)

- Lactating females who plan to breastfeed

- Patients who are pregnant; pregnancy test is required for female patients of
childbearing potential

- 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 pre-existing significant central nervous system pathology that would
preclude treatment with blinatumomab, including: history of severe brain injury,
dementia, cerebellar disease, organic brain syndrome, psychosis, coordination/movement
disorder, or autoimmune disease with CNS involvement are not eligible; patients with a
history of cerebrovascular ischemia/hemorrhage with residual deficits are not
eligible; (patients with a history of cerebrovascular ischemia/hemorrhage remain
eligible provided all neurologic deficits have resolved)

- Patients with uncontrolled seizure disorder are not eligible; (patients with seizure
disorders that do not require antiepileptic drugs, or are well controlled with stable
doses of antiepileptic drugs remain eligible)
We found this trial at
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Charleston, West Virginia 25304
Principal Investigator: Ashley E. Meyer
Phone: 304-388-9944
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Charlotte, North Carolina 28204
Principal Investigator: Joel A. Kaplan
Phone: 800-804-9376
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Charlotte, NC
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Charlotte, North Carolina 28204
Principal Investigator: Jessica A. Bell
Phone: 704-384-5369
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Charlotte, NC
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Chattanooga, Tennessee 37403
Principal Investigator: Manoo G. Bhakta
Phone: 865-331-1812
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Chattanooga, TN
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Chicago, Illinois 60614
Principal Investigator: Nobuko Hijiya
Phone: 773-880-4562
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Chicago, IL
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1200 West Harrison Stree
Chicago, Illinois 60607
(312) 996-4350
Principal Investigator: Mary L. Schmidt
Phone: 312-355-3046
Univ of Illinois A major research university in the heart of one of the world's...
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5841 S Maryland Ave
Chicago, Illinois 60637
1-773-702-6180
Principal Investigator: Jennifer L. McNeer
Phone: 773-702-8222
University of Chicago Comprehensive Cancer Center The University of Chicago Comprehensive Cancer Center (UCCCC) is...
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Chicago, IL
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Principal Investigator: Rabi Hanna
Phone: 866-223-8100
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Cleveland, OH
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Dallas, Texas 75390
Principal Investigator: Tamra L. Slone
Phone: 214-648-7097
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Dallas, TX
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Jagadeesh Ramdas
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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Danville, PA
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Dayton, Ohio 45404
Principal Investigator: Ayman A. El-Sheikh
Phone: 800-228-4055
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Dayton, OH
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Denver, Colorado 80218
Principal Investigator: Jennifer J. Clark
Phone: 866-775-6246
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Denver, CO
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4160 John R St #2122
Detroit, Michigan 48201
(313) 833-1785
Principal Investigator: Meret Henry
Phone: 313-576-9790
Wayne State University/Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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Detroit, MI
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Detroit, Michigan 48236
Principal Investigator: Adonis N. Lorenzana
Phone: 734-712-3671
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9333 Imperial Highway
Downey, California 90242
Principal Investigator: Robert M. Cooper
Phone: 510-891-3400
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Downey, CA
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Susan G. Kreissman
Phone: 888-275-3853
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Durham, NC
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East Lansing, Michigan 48824
Principal Investigator: Aghiad Chamdin
Phone: 517-975-9547
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East Lansing, MI
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El Paso, Texas 79905
Principal Investigator: Lisa L. Hartman
Phone: 915-298-5444
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Principal Investigator: Hector M. Rodriguez-Cortes
Phone: 954-355-5346
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Fort Myers, Florida 33908
Principal Investigator: Emad K. Salman
Phone: 877-680-0008
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Principal Investigator: Kenneth M. Heym
Phone: 682-885-2103
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Fort Worth, TX
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1600 Southwest Archer Road
Gainesville, Florida 32610
Principal Investigator: William B. Slayton
Phone: 352-273-8010
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Gainesville, FL
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835 S Van Buren St
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
(252) 328-6131
Principal Investigator: Andrea R. Whitfield
Phone: 252-744-1015
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
(864)455-8898
Principal Investigator: Nichole L. Bryant
Phone: 864-241-6251
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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30 Prospect Ave
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
Phone: 954-265-2234
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1319 Punahou St
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: Terzah M. Horton
Phone: 713-798-1354
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705 Riley Hospital Dr
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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Jacksonville, Florida 32207
Principal Investigator: Emi H. Caywood
Phone: 904-697-3529
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Kansas City, Missouri 64108
Principal Investigator: Keith J. August
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2018 W Clinch Ave
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
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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Las Vegas, Nevada 89135
Principal Investigator: Alan K. Ikeda
Phone: 702-384-0013
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Julie Kim
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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Lebanon, NH
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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
(501) 364-1100
Principal Investigator: David L. Becton
Phone: 501-686-8274
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
(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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Loma Linda, CA
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Long Beach, California 90806
Principal Investigator: Pamela H. Kempert
Phone: 562-933-5600
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Los Angeles, California 90095
Principal Investigator: William A. May
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Louisville, Kentucky 40202
Principal Investigator: Ashok B. Raj
Phone: 866-530-5516
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Madera, California 93638
Principal Investigator: Vonda L. Crouse
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Marshfield, Wisconsin 54449
Principal Investigator: Michelle A. Manalang
Phone: 800-782-8581
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Eugene Suh
Phone: 708-226-4357
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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