Combination Chemotherapy With or Without Donor Bone Marrow Transplantation in Treating Infants With Previously Untreated Acute Lymphoblastic Leukemia

NCT00022126 | Completed Phase 2 DMC

• 3 other identifiers: AALL01P1COG-AALL01P1CDR0000068787
• Study Type: interventional
• Target: 6
• Locations: 3 countries
• Sites: 51

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Bone marrow transplantation allows the doctor to give higher doses of chemotherapy and kill more cancer cells. 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.

Conditions

Leukemia

Keywords

untreated childhood acute lymphoblastic leukemia; L1 childhood acute lymphoblastic leukemia; L2 childhood acute lymphoblastic leukemia; acute undifferentiated leukemia

Outcome Measures

Primary Outcomes (1)

• Establish whether the CCG Augmented Regimen (AR) can be successfully administered in the infant age group

Secondary Outcomes (2)

• Grade 3 or 4 non-hematologic toxicity rates

• Event-free survival

Study Arms (1)

Modified Augmented BFM Therapy

EXPERIMENTAL

Drug: asparaginase; Drug: cyclophosphamide; Drug: cyclosporine; Drug: cytarabine; Drug: daunorubicin hydrochloride; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: mercaptopurine; Drug: methotrexate; Drug: methylprednisolone; Drug: pegaspargase; Drug: thioguanine; Drug: vincristine sulfate; Procedure: allogeneic bone marrow transplantation; Radiation: radiation therapy

Interventions

asparaginase DRUG

Modified Augmented BFM Therapy

cyclophosphamide DRUG

Modified Augmented BFM Therapy

cyclosporine DRUG

Modified Augmented BFM Therapy

cytarabine DRUG

Modified Augmented BFM Therapy

daunorubicin hydrochloride DRUG

Modified Augmented BFM Therapy

dexamethasone DRUG

Modified Augmented BFM Therapy

doxorubicin hydrochloride DRUG

Modified Augmented BFM Therapy

mercaptopurine DRUG

Modified Augmented BFM Therapy

methotrexate DRUG

Modified Augmented BFM Therapy

methylprednisolone DRUG

Modified Augmented BFM Therapy

pegaspargase DRUG

Modified Augmented BFM Therapy

thioguanine DRUG

Modified Augmented BFM Therapy

vincristine sulfate DRUG

Modified Augmented BFM Therapy

allogeneic bone marrow transplantation PROCEDURE

Modified Augmented BFM Therapy

radiation therapy RADIATION

Modified Augmented BFM Therapy

Eligibility Criteria

• Age: Up to 1 Year
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

DISEASE CHARACTERISTICS: * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (51)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Children's Hospital Los Angeles

Los Angeles, California, 90027-0700, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Children's Hospital Central California

Madera, California, 93638-8762, United States

Location

Children's Hospital of Oakland

Oakland, California, 94609-1809, United States

Location

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

Orange, California, 92868, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

Children's Hospital of Denver

Denver, Colorado, 80218-1088, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06360-7106, United States

Location

Alfred I. duPont Hospital for Children

Wilmington, Delaware, 19899, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Emory University Hospital - Atlanta

Atlanta, Georgia, 30322, United States

Location

Children's Healthcare of Atlanta - Scottish Rite

Atlanta, Georgia, 30342, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60601, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

John Stoddard Cancer Center at Iowa Methodist Medical Center

Des Moines, Iowa, 50309, United States

Location

Holden Comprehensive Cancer Center at University of Iowa

Iowa City, Iowa, 52242-1009, United States

Location

MBCCOP - LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0914, United States

Location

Children's Hospitals and Clinics - Minneapolis

Minneapolis, Minnesota, 55404, United States

Location

Children's Hospitals and Clinics - Minnesota

Saint Paul, Minnesota, 55102, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Herbert Irving Comprehensive Cancer Center at Columbia University

New York, New York, 10032, United States

Location

Lineberger Comprehensive Cancer Center, UNC

Chapel Hill, North Carolina, 27599-7295, United States

Location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

Children's Hospital of Columbus

Columbus, Ohio, 43205-2696, United States

Location

Children's Medical Center - Dayton

Dayton, Ohio, 45404, United States

Location

Doernbecher Children's Hospital

Portland, Oregon, 97201-3098, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033-0850, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Methodist Cancer Center

San Antonio, Texas, 78229-3902, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Children's Hospital and Regional Medical Center - Seattle

Seattle, Washington, 98105, United States

Location

Deaconess Medical Center

Spokane, Washington, 99210-0248, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98431-5000, United States

Location

CCOP - St. Vincent Hospital Cancer Center, Green Bay

Green Bay, Wisconsin, 54301, United States

Location

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

CCOP - Marshfield Clinic Research Foundation

Marshfield, Wisconsin, 54449, United States

Location

Women's and Children's Hospital

North Adelaide, South Australia, 5006, Australia

Location

Princess Margaret Hospital for Children

Perth, Western Australia, 6006, Australia

Location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3J 3G9, Canada

Location

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Biphenotypic, Acute

Interventions

Asparaginase; Cyclophosphamide; Cyclosporine; Cytarabine; Daunorubicin; Dexamethasone; Doxorubicin; Mercaptopurine; Methotrexate; Methylprednisolone; pegaspargase; Thioguanine; Vincristine; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Sulfhydryl Compounds; Sulfur Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Aminopterin; Pterins; Pteridines; Prednisolone; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Therapeutics

Study Officials

• Paul S. Gaynon, MD

  Children's Hospital Los Angeles

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2001
• First Posted: January 27, 2003
• Study Start: November 1, 2002
• Primary Completion: January 1, 2005
• Study Completion: April 1, 2006
• Last Updated: February 20, 2014

Record last verified: 2014-02

Locations

AU (2); CA (2); US (47)