Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia
NCT ID: NCT00022126
Last Updated: 2014-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
6 participants
INTERVENTIONAL
2002-11-30
2006-04-30
Brief Summary
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PURPOSE: Phase II trial to compare the effectiveness of combination chemotherapy with or without donor bone marrow transplantation in treating infants who have previously untreated acute lymphoblastic leukemia.
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Detailed Description
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* Determine the feasibility of dexamethasone-based induction chemotherapy followed by augmented Berlin-Frankfurt-Munster (BFM) consolidation chemotherapy with or without allogeneic bone marrow transplantation in infants with previously untreated acute lymphoblastic leukemia.
* Determine the event-free survival of patients treated with this regimen.
* Determine the clinical prognostic features associated with outcome in these patients.
* Compare the biologic characteristics of the leukemia cells with outcome in these patients.
OUTLINE: This is a multicenter study.
Patients receive induction therapy comprising oral dexamethasone 3 times daily on days 1-14; daunorubicin IV on days 1, 8, and 15; vincristine IV on days 1, 8, 15, and 22; and asparaginase intramuscularly (IM) on days 4, 6, 8, 11, 13, 15, 18, 20, and 22. Patients also receive methotrexate intrathecally (IT) on days 1, 8, and 15 (and days 4 and 22 for overt CNS disease).
Patients with M1 or M2 marrow after induction therapy receive augmented consolidation therapy when blood counts recover. Patients receive cyclophosphamide IV on days 1 and 29; cytarabine IV or subcutaneously (SC) on days 2-5, 9-12, 30-33, and 37-40; oral mercaptopurine on days 1-14 and 29-42; vincristine IV on days 15, 22, 43, and 50; pegaspargase IM on days 15 and 43; and methotrexate IT on days 1, 8, and 15.
Patients who do not receive bone marrow transplantation (BMT) proceed to interim maintenance #1 when blood counts recover. Patients receive methotrexate IT on days 1, 11, 22, and 32; methotrexate IV and vincristine IV on days 1, 11, 22, 32, and 43; and pegaspargase IM on days 2 and 23.
When blood counts recover, patients receive delayed intensification #1 comprising vincristine IV on days 1, 8, 15, 43, and 50; doxorubicin IV on days 1, 8, and 15; oral dexamethasone 3 times daily on days 1-7 and 15-21; pegaspargase IM on days 4 and 43; cyclophosphamide IV on day 29; methotrexate IT on days 29 and 36; oral thioguanine on days 29-42; and cytarabine IV or SC on days 30-33 and 37-40.
When blood counts recover, patients receive interim maintenance #2 comprising vincristine as in interim maintenance #1; methotrexate IT on day 1 and IV on days 1, 11, 22, 32, and 41; and pegaspargase IM on days 2 and 23.
When blood counts recover, patients receive delayed intensification #2 comprising vincristine, doxorubicin, dexamethasone, pegaspargase, cyclophosphamide, cytarabine, and thioguanine as in intensification #1. Patients also receive methotrexate IT on days 1 and 29.
When blood counts recover, patients receive maintenance therapy comprising methotrexate IT on day 1 and orally on days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78; vincristine IV on days 1, 29, and 57; oral dexamethasone 3 times daily on days 1-5, 29-33, and 57-61; and oral mercaptopurine daily. Treatment repeats every 84 days for 6 courses.
Patients with an allergy to pegaspargase replace it with asparaginase IM on the days after receiving methotrexate IV during interim maintenance #1 and #2 and daily over 6 days in place of each dose of pegaspargase during delayed intensification #1 and #2.
After augmented consolidation therapy, patients meeting the following criteria may receive BMT in place of chemotherapy:
* In remission
* Exhibiting chromosome translocation involving 11q23 or Ph+{(9;22)}
* Available HLA-A, B, DR genotypic identical relative donor
* No uncontrolled infection
* Adequate organ function Within 3-4 weeks of consolidation therapy, patients undergoing allogeneic BMT receive cytarabine IV over 1 hour on days -8 to -5; cyclophosphamide IV over 30 minutes on days -7 and -6; and methylprednisolone IV twice daily on days -2 to 0. Patients also undergo total body irradiation twice daily on days -3 to 0. Patients receive allogeneic BMT on day 0. Patients also receive cyclosporine IV every 12 hours beginning on day -1, switching to oral when possible, and continuing until day 60. Patients then taper cyclosporine over the next 60-120 days.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1-2 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 20-40 patients will be accrued for this study within 2 years.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Modified Augmented BFM Therapy
asparaginase
cyclophosphamide
cyclosporine
cytarabine
daunorubicin hydrochloride
dexamethasone
doxorubicin hydrochloride
mercaptopurine
methotrexate
methylprednisolone
pegaspargase
thioguanine
vincristine sulfate
allogeneic bone marrow transplantation
radiation therapy
Interventions
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asparaginase
cyclophosphamide
cyclosporine
cytarabine
daunorubicin hydrochloride
dexamethasone
doxorubicin hydrochloride
mercaptopurine
methotrexate
methylprednisolone
pegaspargase
thioguanine
vincristine sulfate
allogeneic bone marrow transplantation
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of previously untreated acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia
* CNS or testicular disease allowed
* No L3 sIg+ ALL or acute myelogenous leukemia
* At least 36 weeks gestation for congenital ALL
PATIENT CHARACTERISTICS:
Age:
* Under 366 days at diagnosis
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* Not specified
Endocrine therapy:
* Steroid therapy within 48 hours of study allowed if complete blood counts and lumbar puncture results known
* No chronic steroid treatment for other disease
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No other concurrent cytotoxic therapy
1 Year
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Paul S. Gaynon, MD
Role: STUDY_CHAIR
Children's Hospital Los Angeles
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States
Children's Hospital Central California
Madera, California, United States
Children's Hospital of Oakland
Oakland, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center
Orange, California, United States
Children's Hospital of Orange County
Orange, California, United States
Children's Hospital of Denver
Denver, Colorado, United States
University of Connecticut Health Center
Farmington, Connecticut, United States
Alfred I. duPont Hospital for Children
Wilmington, Delaware, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Emory University Hospital - Atlanta
Atlanta, Georgia, United States
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, United States
University of Chicago Cancer Research Center
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Children's Hospitals and Clinics - Minneapolis
Minneapolis, Minnesota, United States
Children's Hospitals and Clinics - Minnesota
Saint Paul, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Mount Sinai School of Medicine
New York, New York, United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York, New York, United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Columbus
Columbus, Ohio, United States
Children's Medical Center - Dayton
Dayton, Ohio, United States
Doernbecher Children's Hospital
Portland, Oregon, United States
CCOP - Columbia River Oncology Program
Portland, Oregon, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Methodist Cancer Center
San Antonio, Texas, United States
CCOP - Scott and White Hospital
Temple, Texas, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
Children's Hospital and Regional Medical Center - Seattle
Seattle, Washington, United States
Deaconess Medical Center
Spokane, Washington, United States
Madigan Army Medical Center
Tacoma, Washington, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States
Women's and Children's Hospital
North Adelaide, South Australia, Australia
Princess Margaret Hospital for Children
Perth, Western Australia, Australia
British Columbia Children's Hospital
Vancouver, British Columbia, Canada
IWK Health Centre
Halifax, Nova Scotia, Canada
Countries
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Other Identifiers
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COG-AALL01P1
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000068787
Identifier Type: OTHER
Identifier Source: secondary_id
AALL01P1
Identifier Type: -
Identifier Source: org_study_id
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