Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission
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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: 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: 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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label 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 |
- Overall Survival [ Time Frame: All patients were followed for 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 1929 |
| Study Start Date: | April 1993 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Transplant
Allogeneic (if donor) or Autologous (if no donor) bone marrow transplant
|
Biological: sargramostim Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: etoposide Drug: imatinib mesylate Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: vincristine sulfate Procedure: allogeneic bone marrow transplantation Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation |
|
Active Comparator: Conventional Consolidation/Maintenance
Consolidation/Maintenance Therapy
|
Drug: asparaginase Drug: cyclophosphamide Drug: cytarabine Drug: daunorubicin hydrochloride Drug: dexamethasone Drug: etoposide Drug: leucovorin calcium Drug: mercaptopurine Drug: methotrexate Drug: prednisone Drug: thioguanine Drug: vincristine sulfate Radiation: radiation therapy |
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
- Patients with myeloid antigen expression AND unequivocal lymphoid immunophenotype are eligible
Philadelphia (Ph) chromosome status determined by cytogenetics, fluorescence in situ hybridization (FISH), and/or RNA analysis
- Patients determined to be Ph chromosome negative by cytogenetics, but positive for BCR-ABL by FISH or polymerase chain reaction are considered Ph chromosome positive
- Patients with Ph chromosome-positive disease may be up to age 65
- No myelodysplasia or other antecedent hematologic disorder
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
- A and B typing required
- C and DR typing done if feasible
Allogeneic stem cell transplantation patients must meet the following criteria:
Appropriate HLA histocompatible donor available
- Ph chromosome-negative patients must have HLA identical sibling
- Ph chromosome-positive patients must have HLA identical, HLA-matched unrelated, or haploidentical related donor
Postinduction therapy:
- CSF negative for leukemia
- No occult or overt leukemic meningitis
- Documented complete remission
PATIENT CHARACTERISTICS:
Age:
- 15 to 65
Performance status:
Induction therapy:
- Not specified
Postinduction therapy:
- 0-1
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
Induction therapy:
- Direct bilirubin ≤ 2.0 mg/dL
Postinduction therapy:
- Direct bilirubin < 2.0 mg/dL
- SGPT or SGOT < 3 times normal
Renal:
Induction therapy:
- Creatinine < 2 mg/dL
Postinduction therapy:
- Creatinine ≤ 2 mg/dL
- Creatinine clearance ≥ 60 mL/min
Cardiovascular:
Induction and postinduction therapy:
- No significant cardiac disease requiring digoxin and/or diuretics
- No major ventricular dysrhythmia requiring medication
- No ischemic heart disease requiring medication
Postinduction therapy:
- Cardiac ejection fraction ≥ 50% for patients under consideration for transplantation
Pulmonary:
Induction therapy:
- Not specified
Postinduction therapy:
- FEV_1 ≥ 60% of predicted for patients under consideration for transplantation
- DLCO ≥ 50% of predicted for patients under consideration for transplantation
Other:
Induction and postinduction therapy:
- HIV negative
- No concurrent organ damage or other medical problem (e.g., psychiatric disorder or drug abuse) that would preclude study therapy
- Not pregnant
Postinduction therapy:
- No persistent infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent umbilical cord allogeneic transplantation
Chemotherapy:
- Not specified
Endocrine therapy:
- Prior corticosteroids for ALL allowed
Radiotherapy:
- Not specified
Surgery:
- Not specified
Other:
Induction and postinduction therapy:
- No other prior therapy for ALL
Postinduction therapy:
- No concurrent antibiotics
Contacts and Locations
Show 94 Study Locations| Study Chair: | Jacob M. Rowe, MD | Rambam Health Care Campus |
| Principal Investigator: | Mark R. Litzow, MD | Mayo Clinic |
| Study Chair: | Antony H. Goldstone, FRCP | University College London Hospitals |
More Information
Additional Information:
Publications:
| Responsible Party: | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00002514 History of Changes |
| Obsolete Identifiers: | NCT00222586 |
| Other Study ID Numbers: | CDR0000078099, E2993, MRC-LEUK-UKALL-XII, EST-4491 |
| Study First Received: | November 1, 1999 |
| Last Updated: | November 21, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Eastern Cooperative Oncology Group:
|
adult acute lymphoblastic leukemia in remission |
Additional relevant MeSH terms:
|
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 Prednisone Vincristine BB 1101 Dexamethasone acetate Dexamethasone 21-phosphate Leucovorin Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic |
ClinicalTrials.gov processed this record on May 19, 2013