Comparison of Different Combination Chemotherapy Regimens in Treating Children With Acute Lymphoblastic Leukemia



Status:Completed
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:1 - 9
Updated:4/21/2016
Start Date:June 2000
End Date:June 2008

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Escalating Dose Intravenous Methotrexate Without Leucovorin Rescue Versus Oral Methotrexate and Single Versus Double Delayed Intensification for Children With Standard Risk Acute Lymphoblastic Leukemia

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not
yet known which combination chemotherapy regimen is more effective in treating childhood
acute lymphoblastic leukemia.

PURPOSE: This randomized phase III trial is comparing different combination chemotherapy
regimens to see how well they work in treating children with acute lymphoblastic leukemia.

OBJECTIVES:

- Compare the event-free survival and overall survival of children with standard-risk
acute lymphoblastic leukemia treated with escalating-dose IV methotrexate without
leucovorin calcium versus oral methotrexate during the interim maintenance phase of
therapy.

- Compare the event-free survival and overall survival of these patients after receiving
treatment in two delayed intensification phases versus one delayed intensification
phase.

- Compare the toxic effects of oral versus escalating-dose intravenous methotrexate in
these patients.

- Determine the prognostic significance of the rate of disappearance of peripheral
lymphoblasts and lymphocytes during the first week of treatment in these patients.

- Determine the prognostic significance of trisomies of chromosomes 4, 5, 10, and 17 and
early treatment response in patients treated with these regimens.

- Determine the prognostic significance of the TEL-AML1 fusion transcript and early
treatment response in patients treated with these regimens.

- Determine the minimal residual disease (MRD) by polymerase chain reaction in bone
marrow and cerebrospinal fluid at various stages of therapy in these patients.

- Determine the prognostic significance of MRD during various stages of therapy in these
patients.

- Determine whether a second delayed intensification therapy improves the prognosis of
patients who have MRD at the end of induction therapy.

OUTLINE: This is a randomized, multicenter study. Patients without CNS disease at diagnosis,
achieving a specified early marrow response profile and M1 marrow status of less than 5%
blasts in the bone marrow (regardless of the proportion of mature lymphocytes) by day 28 of
induction therapy, and remaining event free with favorable bone marrow status and
cytogenetics between day 21 and 28 of consolidation therapy are randomized to one of four
treatment arms. Patients with CNS disease at diagnosis are assigned to treatment arm II and
undergo cranial irradiation. Patients with any of the following unfavorable bone marrow
features and/or unfavorable cytogenetic features are assigned to the augmented treatment
regimen by day 21 of induction chemotherapy or at the beginning of consolidation
chemotherapy:

NOTE: All T-cell precursor patients that are not more than 4 months past completion of the
delayed intensification phase of therapy should be switched to the augmented regimen as of
3/8/2004. These patients may be switched to the augmented regimen. The protocol gives
specific instructions according to the phase of therapy the patients are actually in.

- Unfavorable marrow status:

- M2: 5-25% blasts in bone marrow at day 28 of induction chemotherapy (or at day 14
of induction chemotherapy if day 7 status is M3) OR

- M3: More than 25% blast cell in bone marrow, regardless of the proportion of
mature lymphocytes at day 14 of induction chemotherapy

- Unfavorable cytogenetics: Must have 1 of the following:

- t(9;22)(q34;q11)

- t(4;11)(q21;q23)

- Balanced t(1;19)(q23;p13)

- Hypodiploidy with less than 45 chromosomes

- Other 11q23 translocations involving MLL Patients receive standard induction
chemotherapy comprising cytarabine (ARA-C) intrathecally (IT) on day 0 or up to 72
hours before day 0; oral dexamethasone (DM) twice daily on days 0-27; vincristine
(VCR) IV on days 0, 7, 14, and 21; and pegaspargase (PEG-ASP) intramuscularly (IM)
once between days 3-5. Patients without CNS disease at diagnosis receive
methotrexate (MTX) IT on days 7 and 28. Patients with CNS disease at diagnosis
receive MTX IT on days 7, 14, 21, and 28.

Patients who have achieved M1 marrow status by day 28 of induction therapy and have
favorable early bone marrow response and cytogenetics proceed to standard consolidation
therapy once blood counts have recovered. Patients with M3 bone marrow status at day 28 of
induction therapy are taken off the protocol. All other patients are assigned to the
augmented treatment regimen.

Beginning on day 28 of induction chemotherapy, patients receive standard consolidation
chemotherapy comprising VCR IV on day 0 and oral mercaptopurine (MP) on days 0-27. Patients
without CNS disease at diagnosis receive MTX IT on days 7, 14, 21, and 28. Patients with CNS
disease at diagnosis receive MTX IT on day 7 and cranial irradiation 5 days a week for 2
weeks. Patients with testicular disease receive bilateral testicular radiotherapy 5 days a
week for 1 week and then for 3 consecutive days during the next week.

NOTE: As of 3/8/2004, patients with T-cell disease who did not achieve M1 marrow status by
day 14 of induction OR who did not receive augmented induction and/or consolidation
(regardless of early marrow status) receive cranial irradiation.

- Arm I: Beginning on day 28 of consolidation chemotherapy, patients receive interim
maintenance I chemotherapy comprising oral DM twice daily on days 0-4 and 28-32; VCR IV
on days 0 and 28; oral MTX on days 0, 7, 14, 21, 28, 35, 42, and 49; oral MP on days
0-49; and MTX IT on day 28.

Beginning on day 56 of interim maintenance I chemotherapy, patients receive delayed
intensification chemotherapy comprising oral DM twice daily on days 0-6 and 14-20; VCR IV
and doxorubicin (DOX) IV over 15 minutes to 2 hours on days 0, 7, and 14; PEG-ASP IM on day
3; cyclophosphamide (CTX) IV over 20-30 minutes on day 28; oral thioguanine (TG) on days
28-41; ARA-C IV or subcutaneously (SC) daily on days 28-31 and 35-38; and MTX IT on days 0
and 28.

Beginning on day 56 of delayed intensification chemotherapy, patients receive interim
maintenance II chemotherapy identical to interim maintenance I chemotherapy except patients
receive MTX IT on days 0 and 28.

Beginning on day 56 of interim maintenance II chemotherapy, patients receive maintenance
chemotherapy comprising oral DM twice daily on days 0-4, 28-32, and 56-60; VCR IV on days 0,
28, and 56; oral MP on days 0-83; oral MTX on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70,
and 77; and MTX IT on day 0.

- Arm II: Patients receive interim maintenance I chemotherapy, delayed intensification
chemotherapy, and interim maintenance II chemotherapy as in arm I. Beginning on day 56
of interim maintenance II chemotherapy, patients then receive a second course of
delayed intensification chemotherapy followed by maintenance chemotherapy as in arm I.

- Arm III: Beginning on day 28 of consolidation chemotherapy, patients receive interim
maintenance I chemotherapy comprising VCR IV; escalating doses of MTX IV on days 0, 10,
20, 30, and 40; and MTX IT on day 30. Patients then receive delayed intensification
chemotherapy as in arm I. Patients receive interim maintenance II chemotherapy as in
interim maintenance I chemotherapy, but with IV MTX starting at 2/3 of the maximum
tolerated dose (MTD) attained in interim maintenance I chemotherapy. Patients then
receive maintenance chemotherapy as in arm I.

- Arm IV: Patients receive interim maintenance I chemotherapy as in arm III, delayed
intensification chemotherapy as in arm I, interim maintenance II chemotherapy as in arm
III, delayed intensification II chemotherapy as in arm II, and maintenance chemotherapy
as in arm I.

- Augmented Treatment: Patients receive induction chemotherapy comprising daunorubicin IV
continuously for 48 hours beginning no later than day 21; oral DM twice daily on days
14-27; and VCR IV on days 14 and 21. Patients without CNS disease at diagnosis receive
MTX IT on days 21 and 35. Patients with CNS disease at diagnosis receive MTX IT on days
21 and 28.

NOTE: Patients with T-cell disease should re-start with augmented consolidation and proceed
as per the augmented regimen.

Beginning on day 35 of induction chemotherapy, patients receive consolidation therapy
comprising CTX IV over 20-30 minutes on days 0 and 28; oral MP on days 0-13 and 28-41; ARA-C
IV or SC daily on days 0-3, 7-10, 28-31, and 35-38; VCR IV on days 14, 21, 42, and 49; and
PEG-ASP IM on days 14 and 42. Patients without CNS disease at diagnosis receive MTX IT on
days 7, 14, and 21. Patients with CNS disease at diagnosis receive MTX IT on day 7 and
cranial irradiation as in the randomized treatment section. Patients with testicular
leukemia receive radiotherapy as in the randomized treatment section.

Beginning on day 63 of consolidation chemotherapy, patients receive interim maintenance I
chemotherapy comprising VCR IV on days 0, 10, 20, 30, and 40; escalating doses of MTX IV on
days 10, 20, 30, and 40; PEG-ASP IM on days 1 and 21; and MTX IT on days 0 and 30.

Beginning on day 56 of interim maintenance I chemotherapy, patients receive delayed
intensification I chemotherapy comprising oral DM twice daily on days 0-6 and 14-20; VCR IV
on days 0, 7, 14, 42, and 49; DOX IV over 15 minutes to 2 hours on days 0, 7, and 14;
PEG-ASP IM on days 3 and 42; CTX IV over 20-30 minutes on day 28; oral TG on days 28-41;
ARA-C IV or SC daily on days 28-31 and 35-38; and MTX IT on days 0 and 28.

NOTE: Patients with T-cell disease who are in interim maintenance I chemotherapy with
escalating IV methotrexate should continue this phase and then proceed as per the augmented
regimen. If these patients are receiving conventional interim maintenance chemotherapy with
oral methotrexate, they should stop and restart the interim maintenance as per the augmented
regimen. These patients receive cranial irradiation starting on day 28 of delayed
intensification II chemotherapy.

Beginning on day 56 of delayed intensification I chemotherapy, patients receive interim
maintenance II chemotherapy as in interim maintenance I chemotherapy, but with IV MTX
starting at 2/3 of the MTD attained in interim maintenance I chemotherapy.

NOTE: Patients with T-cell disease who are in delayed intensification I chemotherapy proceed
with this phase, with the addition of 2 vincristine doses on days 42 and 49 and PEG-ASP on
day 42. These patients then proceed as per the augmented regimen with the addition of
cranial irradiation starting on day 28 of delayed intensification II chemotherapy.

NOTE: Patients with T-cell disease who are within 4 months of completing delayed
intensification I chemotherapy and have not received interim maintenance II chemotherapy
with escalating IV methotrexate or delayed intensification II chemotherapy receive a course
of interim maintenance chemotherapy and delayed intensification II chemotherapy according to
the augmented regimen. If these patients have received interim maintenance II chemotherapy
with escalating IV methotrexate, they receive delayed intensification II chemotherapy
according to the augmented regimen. These patients also receive cranial irradiation starting
on day 28 of delayed intensification II chemotherapy and then proceed to maintenance
therapy.

Beginning on day 56 of interim maintenance II chemotherapy, patients receive delayed
intensification II chemotherapy as in delayed intensification I chemotherapy.

Beginning on day 56 of delayed intensification II chemotherapy, patients receive maintenance
chemotherapy comprising oral DM twice daily on days 0-4, 28-32, and 56-60; VCR IV on days 0,
28, and 56; oral MP on days 0-83; oral MTX on days 7, 14, 21, 28, 35, 42, 49, 56, 63, 70,
and 77; and MTX IT on day 0.

Patients are followed every 4-8 weeks for one year, every 3 months for one year, every 6
months for one year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 2,037 randomized patients will be accrued for this study
within 3.75 years.

DISEASE CHARACTERISTICS:

- Diagnosis of previously untreated B-cell precursor acute lymphoblastic leukemia

- More than 25% L1 or L2 lymphoblasts

- No more than 25% L3 lymphoblasts

- WBC < 50,000/mm^3

- No T-cell precursor acute lymphoblastic leukemia by immunophenotyping

- Massive lymphadenopathy, massive splenomegaly, or large mediastinal mass allowed

- CNS or testicular leukemia allowed

- No patients found to have t(8;14)(q24;q32), t(8;22)(q24;q11), and t(2;8)(p11-p12;q24)
(characteristic of Burkitt's lymphoma)

PATIENT CHARACTERISTICS:

Age:

- 1 to 9

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- See Disease Characteristics

Hepatic:

- Not specified

Renal:

- Not specified

Other:

- Not pregnant

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No more than 72 hours since prior intrathecal cytarabine

Endocrine therapy:

- At least 30 days since prior systemic corticosteroids given for more than 48 hours

- Prior corticosteroids for mediastinal mass causing superior mediastinal syndrome
allowed

- Prior or concurrent inhaled corticosteroids allowed

Radiotherapy:

- Prior radiotherapy for mediastinal mass causing superior mediastinal syndrome allowed

- No concurrent spinal radiotherapy

Surgery:

- Not specified
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101 Manning Drive
Chapel Hill, North Carolina 27514
(919) 966-0000
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill One of the...
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2401 West Belvedere Avenue
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1300 Morris Park Avenue
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450 Clarkson Avenue
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1025 Morehead Medical Dr # 600
Charlotte, North Carolina 28204
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Blumenthal Cancer Center at Carolinas Medical Center As our patients wage their personal wars against...
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200 Hawthorne Lane
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Presbyterian Cancer Center at Presbyterian Hospital At Novant Health Presbyterian Medical Center, we are welcoming...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
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7777 Forest Ln # C840
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Medical City Dallas Hospital If you have concerns for your health, that of a family...
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1719 East 19th Avenue
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1200 Pleasant Street
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1500 E Duarte Rd
Duarte, California 91010
(626) 256-4673
City of Hope Comprehensive Cancer Center City of Hope is a leading research and treatment...
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200 Hawkins Drive
Iowa City, Iowa 52242
800-237-1225
Holden Comprehensive Cancer Center at University of Iowa Holden Comprehensive Cancer Center is dedicated to...
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524 South Park Street
Kalamazoo, Michigan 49007
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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
(816) 234-3000
Children's Mercy Hospital Children's Mercy Hospitals and Clinics continues redefining pediatric medicine throughout the Midwest...
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11234 Anderson Street
Loma Linda, California 92354
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Loma Linda University Cancer Institute at Loma Linda University Medical Center Loma Linda University Cancer...
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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
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10833 Le Conte Avenue # 8-950
Los Angeles, California 90095
(310) 825-5268
Jonsson Comprehensive Cancer Center at UCLA In the late 1960s, a group of scientists and...
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231 E Chestnut St
Louisville, Kentucky 40202
(502) 629-6000
Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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4015 22nd Place
Lubbock, Texas 79410
806-725-0000
Covenant Children's Hospital Every child is different. And when they're sick or injured, they deserve...
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777 Hemlock Street
Macon, Georgia 31201
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Medical Center of Central Georgia Navicent Health is a designated Level I Trauma Center and...
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9300 Valley Children's Pl
Madera, California 93720
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New Hyde Park, New York 11042
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New York, New York 10065
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601 Children's Lane
Norfolk, Virginia 23507
(757) 668-7000
Children's Hospital of The King's Daughters Children
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747 52nd St
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
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985950 Nebraska Medical Center
Omaha, Nebraska 68198
402-559-4090
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1201 W La Veta Ave
Orange, California 92868
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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
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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San Diego, CA 92120Bus: -
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Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center The Curtis and...
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201 16th Avenue East
Seattle, Washington 98112
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Spokane, Washington 99210
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750 E Adams St
Syracuse, New York 13210
(315) 464-5540
SUNY Upstate Medical University Hospital SUNY Upstate Medical University in Syracuse, NY, is the only...
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40 Sunshine Cottage Road
Valhalla, New York 10595
(914) 594-4000
New York Medical College The College was founded in 1860 by a group of New...
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1600 Rockland Road
Wilmington, Delaware 19803
(302) 651-4200
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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121 Dekalb Ave
Brooklyn, New York 11205
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Danville, Pennsylvania 17822
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2018 W Clinch Ave
Knoxville, Tennessee 37916
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East Tennessee Children's Hospital East Tennessee Children's Hospital is a not-for-profit, private, independent pediatric medical...
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8700 Beverly Blvd.
Los Angeles, California 90048
1-800-233-2771
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center Cedars-Sinai's Samuel Oschin Comprehensive Cancer Institute...
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Marshfield, Wisconsin 54449
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1000 N Oak Ave
Marshfield, Wisconsin 54449
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Minneapolis, Minnesota 55455
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2200 Children's Way
Nashville, Tennessee 37232
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Vanderbilt Children's Hospital Monroe Carell Jr. Children's Hospital at Vanderbilt is one of the nation's...
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195 Little Albany St
New Brunswick, New Jersey 08903
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Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School As New...
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New Haven, Connecticut 06510
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533 Bolivar Street, Room 420
New Orleans, Louisiana 70112
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MBCCOP - LSU Health Sciences Center Established in 1990, the Stanley S. Scott Cancer Center...
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1275 York Ave
New York, New York 10021
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
2393
mi
from 98109
Newark, NJ
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Omaha, Nebraska 68114
1367
mi
from 98109
Omaha, NE
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984
mi
from 98109
Orange, CA
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Park Ridge, Illinois 60068
1719
mi
from 98109
Park Ridge, IL
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Paterson, New Jersey 07503
2387
mi
from 98109
Paterson, NJ
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
1113
mi
from 98109
Phoenix, AZ
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
2134
mi
from 98109
Pittsburgh, PA
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149
mi
from 98109
Portland, OR
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147
mi
from 98109
Portland, OR
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Randwick, New South Wales 2031
7749
mi
from 98109
Randwick,
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Cancer Center The Mayo Clinic Cancer Center is a National Cancer Institute-designated comprehensive...
1450
mi
from 98109
Rochester, MN
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Royal Oak, Michigan 48073
1922
mi
from 98109
Royal Oak, MI
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3601 W 13 Mile Rd
Royal Oak, Michigan 48073
(248) 898-5000
William Beaumont Hospital-Royal Oak The largest Beaumont Hospital is located at 3601 W Thirteen Mile...
1922
mi
from 98109
Royal Oak, MI
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Sacramento, California 95825
626
mi
from 98109
Sacramento, CA
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San Antonio, Texas 78229
1779
mi
from 98109
San Antonio, TX
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1779
mi
from 98109
San Antonio, TX
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