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Sponsors and Collaborators: |
Eastern Cooperative Oncology Group National Cancer Institute (NCI) Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002514 |
RATIONALE: Drugs used in chemotherapy work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with allogeneic or autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known whether stem cell transplantation is more effective than standard chemotherapy in treating acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying how well stem cell transplantation works compared to standard combination chemotherapy in treating patients with acute lymphoblastic leukemia in first remission.
Condition | Intervention | Phase |
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Leukemia |
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: filgrastim Drug: imatinib mesylate Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: prednisone Drug: sargramostim Drug: thioguanine Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Phase III Randomized Trial of Autologous and Allogeneic Stem Cell Transplantation Versus Intensive Conventional Chemotherapy in Acute Lymphoblastic Leukemia in First Remission |
Estimated Enrollment: | 590 |
Study Start Date: | April 1993 |
Ages Eligible for Study: | 15 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed acute lymphoblastic leukemia (ALL)
More than 25% lymphoblasts in bone marrow
Philadelphia (Ph) chromosome status determined by cytogenetics, fluorescence in situ hybridization (FISH), and/or RNA analysis
Patients age 50 and under must be HLA typed during induction therapy of study treatment OR provide a written explanation for not undergoing HLA typing
Allogeneic stem cell transplantation patients must meet the following criteria:
Appropriate HLA histocompatible donor available
Postinduction therapy:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Induction therapy:
Postinduction therapy:
Life expectancy:
Hematopoietic:
Hepatic:
Induction therapy:
Postinduction therapy:
Renal:
Induction therapy:
Postinduction therapy:
Cardiovascular:
Induction and postinduction therapy:
Postinduction therapy:
Pulmonary:
Induction therapy:
Postinduction therapy:
Other:
Induction and postinduction therapy:
Postinduction therapy:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Induction and postinduction therapy:
Postinduction therapy:
Study Chair: | Jacob M. Rowe, MD | Rambam Health Care Campus |
Investigator: | Mark R. Litzow, MD | Mayo Clinic |
Study Chair: | Antony H. Goldstone, FRCP | University College London Hospitals |
Study ID Numbers: | CDR0000078099, ECOG-2993, MRC-LEUK-UKALL-XII, EST-4491 |
Study First Received: | November 1, 1999 |
Last Updated: | January 10, 2009 |
ClinicalTrials.gov Identifier: | NCT00002514 |
Health Authority: | United States: Federal Government |
adult acute lymphoblastic leukemia in remission |
Dexamethasone Daunorubicin Prednisone Leukemia, Lymphoid Leucovorin 6-Mercaptopurine Cyclophosphamide Etoposide phosphate Acute lymphoblastic leukemia, adult Leukemia Methotrexate Lymphoma Etoposide |
Dexamethasone acetate Cytarabine Asparaginase Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Thioguanine Vincristine Folic Acid Imatinib Lymphatic Diseases Calcium, Dietary Mitoxantrone Lymphoproliferative Disorders |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Reproductive Control Agents Antibiotics, Antineoplastic Protein Kinase Inhibitors Hormones Sensory System Agents |
Vitamins Therapeutic Uses Abortifacient Agents Analgesics Micronutrients Dermatologic Agents Alkylating Agents Nucleic Acid Synthesis Inhibitors Vitamin B Complex Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Growth Substances Mitosis Modulators Gastrointestinal Agents |