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| Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00022126 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia |
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 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Study of Modified Augmented BFM Therapy for Infants With Acute Lymphoblastic Leukemia |
Eligibility| Ages Eligible for Study: | up to 1 Year |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of previously untreated acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 51 Study Locations| Study Chair: | Paul S. Gaynon, MD | Children's Hospital Los Angeles |
More Information
| Study ID Numbers: | CDR0000068787, COG-AALL01P1 |
| Study First Received: | August 10, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00022126 History of Changes |
| Health Authority: | United States: Federal Government |
|
untreated childhood acute lymphoblastic leukemia L1 childhood acute lymphoblastic leukemia L2 childhood acute lymphoblastic leukemia acute undifferentiated leukemia |
|
Dexamethasone Anti-Inflammatory Agents Cyclosporine Methylprednisolone Miconazole Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Cyclosporins Hormones Pegaspargase Methotrexate Methylprednisolone Hemisuccinate Asparaginase |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Thioguanine Vincristine Glucocorticoids Doxorubicin Folic Acid Antineoplastic Agents, Phytogenic Acute Lymphoblastic Leukemia, Childhood Antimetabolites Daunorubicin Leukemia, Lymphoid Immunologic Factors Clotrimazole |
|
Anti-Inflammatory Agents Dexamethasone Anti-Infective Agents Cyclosporine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Methylprednisolone Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Hormones Cyclosporins Pegaspargase Therapeutic Uses |
Abortifacient Agents Methotrexate Dermatologic Agents Nucleic Acid Synthesis Inhibitors Methylprednisolone Hemisuccinate Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal Immune System Diseases Thioguanine Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Doxorubicin |
