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| Sponsors and Collaborators: |
Eastern Cooperative Oncology Group 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: | 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 |
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
| Study ID Numbers: | CDR0000078099, ECOG-2993, MRC-LEUK-UKALL-XII, EST-4491 |
| Study First Received: | November 1, 1999 |
| Last Updated: | May 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00002514 History of Changes |
| Health Authority: | United States: Federal Government |
|
adult acute lymphoblastic leukemia in remission |
|
Dexamethasone Anti-Inflammatory Agents Prednisone Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Protein Kinase Inhibitors Hormones Methotrexate Etoposide Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Antineoplastic Agents, Hormonal |
Thioguanine Vincristine Glucocorticoids Imatinib Folic Acid Mitoxantrone Antineoplastic Agents, Phytogenic Antimetabolites Daunorubicin Leukemia, Lymphoid Immunologic Factors Folate Leucovorin Cyclophosphamide Etoposide phosphate |
|
Anti-Inflammatory Agents Dexamethasone Prednisone Anti-Infective Agents Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics 6-Mercaptopurine Protein Kinase Inhibitors Hormones Therapeutic Uses Abortifacient Agents Methotrexate |
Dermatologic Agents Nucleic Acid Synthesis Inhibitors Asparaginase Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Immune System Diseases Antineoplastic Agents, Hormonal Thioguanine Vincristine Abortifacient Agents, Nonsteroidal Glucocorticoids Imatinib Neoplasms Mitoxantrone Antineoplastic Agents, Phytogenic |