Low-Dose or High-Dose Vincristine and Combination Chemotherapy in Treating Young Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia



Status:Active, not recruiting
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 29
Updated:4/21/2016
Start Date:March 2007

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Intensive Treatment for Intermediate-Risk Relapse of Childhood B-precursor Acute Lymphoblastic Leukemia (ALL): A Randomized Trial of Vincristine Strategies

This randomized phase III trial is studying low-dose vincristine to see how well it works
compared with high-dose vincristine when given together with different combination
chemotherapy regimens in treating young patients with intermediate-risk relapsed B-cell
acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the
growth of cancer cells, either by killing the cells or by stopping them from dividing.
Giving more than one drug (combination chemotherapy) and giving the drugs in different ways
and different doses may kill more cancer cells..

PRIMARY OBJECTIVES:

I. Determine the efficacy of an intensive chemotherapy regimen (based on POG-9412) for
pediatric patients with intermediate-risk relapsed B-precursor acute lymphoblastic leukemia.

SECONDARY OBJECTIVES:

I. To determine levels of minimal residual disease (MRD) present at the end of the first &
third blocks of Induction and determine if higher MRD levels at these times identify
patients at higher risk of relapse who might be candidates for alternative therapies in
future trials.

II. To determine whether common polymorphisms in candidate genes are associated with the
frequency of vincristine adverse effects (peripheral neuropathy, syndrome of inappropriate
antidiuretic hormone secretion [SIADH], or constipation) and with anti-leukemic response
(level of end-Induction MRD).

III. Compare, descriptively, the outcomes of patients treated with combination chemotherapy
vs those treated with matched sibling-related donor hematopoietic stem cell transplantation
(for those with eligible donors).

IV. To use deoxyribonucleic acid (DNA) arrays to characterize patterns of gene expression
that predict treatment failure, and to compare gene expression profiles at the time of
relapse with those at initial diagnosis to gain an understanding of the pathways that may be
involved in disease resistance.

OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2
treatment regimens (randomization closed as of 09/2010).

INDUCTION THERAPY 1 (WEEKS 1-5):

Regimen A: Patients receive low-dose vincristine intravenously (IV) on days 1, 8, 15, and
22; prednisone orally (PO) 3 times daily (TID) on days 1-28; doxorubicin hydrochloride IV
over 15 minutes on day 1; pegaspargase intramuscularly (IM) on days 2, 8, 15, and 22;
cytarabine intrathecally (IT) on day 1; and methotrexate IT* on days 15 and 29.

Regimen B: (closed to accrual as of 09/2010)***: Patients receive high-dose vincristine IV
on days 1, 8, 15, and 22 and prednisone, doxorubicin hydrochloride, pegaspargase,
cytarabine, and methotrexate* as in Regimen A.

NOTE: *Central nervous system (CNS)-positive patients do not receive methotrexate IT. In
both arms, CNS-positive patients receive intrathecal triple therapy (ITT) comprising
methotrexate IT, hydrocortisone IT, and cytarabine IT on days 1, 8, 15, 22, and 29.
CNS-positive patients not achieving remission after induction therapy 1 receive one
additional dose of ITT on day 36. Patients in both arms then proceed to induction therapy
2**.

NOTE: **Patients who are CNS-positive at relapse receive induction therapy 3 BEFORE
induction therapy 2.

NOTE: ***Patients already enrolled on Regimen B are crossover to Regimen A.

INDUCTION THERAPY 2 (WEEKS 6-10 or 7-11): Once blood counts recover, all patients receive
etoposide phosphate IV over = 1 hour and cyclophosphamide IV over 1 hour on days 1-5;
high-dose methotrexate IV continuously over 24 hours on day 22; leucovorin calcium IV or PO
beginning 42 hours after start of high-dose methotrexate and continuing every 6 hours for at
least 3 doses; and methotrexate IT* on days 1 and 22. Patients also receive filgrastim
(G-CSF) IV or subcutaneously (SC) beginning on day 6 and continuing until blood counts
recover.

NOTE: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive
ITT on days 1 and 22. Patients with testicular-relapse with persistent testicular disease at
the end of induction therapy 1 undergo testicular radiotherapy once daily (QD), 5 days a
week, for 12 days during induction therapy 2**.

NOTE: **Radiotherapy should be completed before beginning high-dose methotrexate (week 9)
chemotherapy.

All patients then proceed to induction therapy 3.

INDUCTION THERAPY 3 (WEEKS 11-15 or 12-16): All patients receive high-dose cytarabine IV
over 3 hours on days 1, 2, 8, and 9, and asparaginase IM on days 2 and 9. Patients also
receive G-CSF IV or SC beginning on day 10 and continuing until blood counts recover.
Patients with a suitable HLA-matched related donor are removed from study and proceed to
stem cell transplantation. Patients without a suitable HLA-matched related donor proceed to
intensification therapy 1 (as per their randomized regimen in induction therapy 1).

INTENSIFICATION THERAPY 1 (WEEKS 16-27 or 17-28):

Regimen A: Patients receive low-dose vincristine IV and high-dose methotrexate IV
continuously over 24 hours on day 1; leucovorin calcium IV or orally beginning 42 hours
after start of high-dose methotrexate and continuing every 6 hours for at least 3 doses;
oral mercaptopurine once daily on days 2-6; etoposide phosphate IV over ≥ 1 hour and
cyclophosphamide IV over 1 hour on day 8; and methotrexate IT* on day 15. Treatment repeats
every 21 days for 4 courses (with the exception of IT methotrexate which repeats for only 3
courses).

Regimen B: Patients receive high-dose vincristine IV on day 1 and high-dose methotrexate,
leucovorin calcium, mercaptopurine, etoposide phosphate, cyclophosphamide, and methotrexate
IT* as in Regimen A. (closed to accrual as of 09/2010)

NOTE: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive
ITT on day 15. ITT repeats every 3 weeks for 3 courses.

NOTE: ** Patients already enrolled on Regimen B are crossover to Regimen A.

Patients in both regimens then proceed to reinduction therapy (as per their randomized
regimen in induction therapy 1).

REINDUCTION THERAPY (WEEKS 28-32 or 29-33):

Regimen A: Patients receive low-dose vincristine IV and doxorubicin hydrochloride IV over 15
minutes on days 1, 8, and 15, oral dexamethasone twice daily on days 1-7 and 15-21,
pegaspargase IM on days 2 and 15, and methotrexate IT* on days 1 and 28.

Regimen B: Patients receive high-dose vincristine IV on days 1, 8, and 15 and doxorubicin
hydrochloride, dexamethasone, pegaspargase, and methotrexate IT* as in Regimen A. (closed to
accrual as of 09/2010)

NOTE: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive
ITT on days 1 and 28.

NOTE: ** Patients already enrolled on Regimen B are crossover to Regimen A. Patients in both
regimens then proceed to intensification therapy 2 (as per their randomized regimen in
induction therapy 1).

INTENSIFICATION THERAPY 2 (WEEKS 33-56 or 34-57):

Regimen A: Once blood counts recover, patients receive high-dose cytarabine IV over 3 hours
on days 1 and 2; pegaspargase IM on day 2; low-dose vincristine IV on days 22 and 29;
high-dose methotrexate IV on day 22; leucovorin calcium IV or orally beginning 42 hours
after start of high-dose methotrexate and continuing every 6 hours for at least 3 doses;
oral mercaptopurine once daily on days 23-27; etoposide phosphate IV over ≥ 1 hour and
cyclophosphamide IV over 1 hour on day 29; and methotrexate IT* on day 36. Patients also
receive G-CSF IV or SC beginning on day 3 and continuing until blood counts recover.
Treatment repeats every 42 days for 4 courses (with the exception of IT methotrexate which
only repeats for 3 courses).

Regimen B: Patients receive high-dose cytarabine, high-dose methotrexate, leucovorin
calcium, pegaspargase, mercaptopurine, etoposide phosphate, cyclophosphamide, methotrexate
IT*, and G-CSF as in Regimen A. Patients also receive high-dose vincristine IV on days 22
and 29.

NOTE: *CNS-positive patients do not receive methotrexate IT. CNS-positive patients receive
ITT on day 36. Treatment repeats every 6 weeks for 3 courses.

Patients in both regimens then proceed to maintenance therapy (as per their randomized
regimen in induction therapy 1).

MAINTENANCE THERAPY (week 57-106 or 58-107):

Regimen A: Patients receive methotrexate IT on day 1* and then PO on days 8, 15, 22, 29, and
36; mercaptopurine PO QD on days 1-42; dexamethasone PO twice daily (BID) on days 1-5; and
low-dose vincristine IV and cyclophosphamide IV over 1 hour on days 43, 50, 57, and 64.
Treatment repeats every 70 days for 5 courses.

Regimen B: Patients receive methotrexate*, mercaptopurine, dexamethasone, and
cyclophosphamide as in Regimen A. Patients also receive high-dose vincristine IV on days 43,
50, 57, and 64.

NOTE: *CNS-positive patients receive methotrexate IT on day 1, instead of oral methotrexate.

Beginning in week 1 of the first maintenance therapy course, patients with CNS relapse
undergo cranial radiotherapy QD, 5 days a week, for 10 days. Patients with CNS relapse do
not receive any IT therapy during maintenance therapy.

After completion of study therapy, patients are followed periodically for 5 years.

Inclusion Criteria:

- Diagnosis of acute lymphoblastic leukemia (ALL)

- Bone marrow with > 25% L1 or L2 lymphoblasts (M3 marrow)

- Patients with > 25% L3 marrow lymphoblasts and/or evidence of c-myc
translocation are not eligible (considered Burkitt's or mature B-cell
leukemia)

- Intermediate-risk relapsed disease, meeting 1 of the following criteria:

- Bone marrow relapse ≥ 36 months after initial diagnosis (defined as M3 marrow
after previous remission from ALL)

- Combined bone marrow and extramedullary (CNS* and/or testicular**) relapse ≥ 36
months after initial diagnosis

- Isolated extramedullary (CNS* and/or testicular**) relapse < 18 months after
initial diagnosis

- The following subtypes are not allowed:

- T-lineage ALL

- Mature B-cell (Burkitt's) leukemia (defined as L3 morphology and/or evidence of
c-myc translocation)

- Philadelphia-chromosome positive disease

- No Down syndrome (trisomy 21)

- Shortening fraction >= 27% by echocardiogram OR ejection fraction >= 50% by
radionuclide angiogram

- Bilirubin < 3.0 mg/dL

- Not pregnant

- Fertile patients must use effective contraception

- No history of peripheral neuropathy >= grade 3 within the past month

- No toxicity (i.e. peripheral neuropathy) >= grade 3 attributable to vincristine
within the past month

- At least 5 days since prior intrathecal chemotherapy

- No prior hematopoietic stem cell or marrow transplantation

- No prior cranial radiotherapy > 1200 cGy (for patients with CNS relapse)

- No concurrent stem cell transplant

- No concurrent alternative therapy

- No concurrent itraconazole in patients receiving vincristine

- No concurrent intensity-modulated radiotherapy
We found this trial at
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Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Dayton, OH
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Denver, CO
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Des Moines, Iowa 50309
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4760 Sunset Blvd
Downey, California 90027
(323) 783-6151
Southern California Permanente Medical Group We
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Duarte, California 91010
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
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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835 S Van Buren St
Green Bay, Wisconsin 54301
(920) 433-0111
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Green Bay, WI
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Greenville, NC
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900 West Faris Rd.
Greenville, South Carolina 29605
(864)455-8898
BI-LO Charities Children's Cancer Center The BI-LO Charities Children
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Greenville, South Carolina 29605
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-8521
Penn State Hershey Children's Hospital Penn State Milton S. Hershey Medical Center, Penn State College...
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Hershey, PA
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705 Riley Hospital Dr
Indianapolis, Indiana 46202
(317) 944-5000
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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2001 W 86th St
Indianapolis, Indiana 46260
(317) 338-2345
Saint Vincent Hospital and Health Services At St.Vincent Indianapolis, everything we do begins with a...
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Jacksonville, Florida 32207
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Kalamazoo, Michigan 49008
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2018 W Clinch Ave
Knoxville, Tennessee 37916
(865) 541-8000
East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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401 West Greenlawn Avenue
Lansing, Michigan 48910
(517) 975-9500
Michigan State University - Breslin Cancer Center This busy clinic provides care to thousands of...
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601 South Rancho Drive Suite C-26
Las Vegas, Nevada 89106
(702) 384-0013
Nevada Cancer Research Foundation CCOP The Nevada Cancer Research Foundation Community Clinical Oncology Program (NCRF-CCOP)...
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Las Vegas, NV
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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
859) 257-9000
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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94 Old Short Hills Road
Livingston, New Jersey 07039
(973) 322-5000
Saint Barnabas Medical Center As a Barnabas Health facility, Saint Barnabas Medical Center is committed...
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Livingston, NJ
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
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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2801 Atlantic Ave
Long Beach, California 90806
(562) 933-5437
Miller Children's Hospital Miller Children
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Long Beach, CA
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600 Highland Ave
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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