Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission
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ClinicalTrials.gov Identifier: NCT00002514 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : November 22, 2012
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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 or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 1929 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | April 1993 |
Actual Primary Completion Date : | December 2006 |

Arm | Intervention/treatment |
---|---|
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 |
- Overall Survival [ Time Frame: All patients were followed for 2 years ]

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Ages Eligible for Study: | 15 Years to 65 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
-
Histologically confirmed acute lymphoblastic leukemia (ALL)
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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
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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
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Allogeneic stem cell transplantation patients must meet the following criteria:
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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
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-
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002514

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 |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | November 22, 2012 |
Last Verified: | August 2007 |
Keywords provided by Eastern Cooperative Oncology Group:
adult acute lymphoblastic leukemia in remission |
Additional relevant MeSH terms:
Leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma Leukemia, Lymphoid Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Dexamethasone Prednisone Cyclophosphamide Methotrexate Etoposide Cytarabine |
Vincristine Imatinib Mesylate Daunorubicin Asparaginase 6-Mercaptopurine Thioguanine Levoleucovorin Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones |