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| Sponsor: | Eastern Cooperative Oncology Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Medical Research Council |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00002514 |
Purpose
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 |
|---|---|---|
|
Leukemia |
Biological: filgrastim Biological: sargramostim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: imatinib mesylate Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: mitoxantrone hydrochloride Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| 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 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| 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:
Contacts and Locations
Show 94 Study Locations| 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 |
More Information
| ClinicalTrials.gov Identifier: | NCT00002514 History of Changes |
| Obsolete Identifiers: | NCT00222586 |
| Other Study ID Numbers: | CDR0000078099, ECOG-2993, MRC-LEUK-UKALL-XII, EST-4491 |
| Study First Received: | November 1, 1999 |
| Last Updated: | July 12, 2011 |
| Health Authority: | United States: Federal Government |
|
adult acute lymphoblastic leukemia in remission |
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 6-Mercaptopurine Cytarabine Methotrexate Thioguanine Cyclophosphamide Imatinib |
Asparaginase Daunorubicin Dexamethasone Etoposide Mitoxantrone Prednisone Vincristine BB 1101 Lenograstim Dexamethasone acetate Dexamethasone 21-phosphate Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action |