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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00450450 |
RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate and tacrolimus or cyclosporine before and after transplant may stop this from happening. It is not yet known whether donor bone marrow transplant is more effective with or without G-CSF in treating hematologic cancer or other diseases.
PURPOSE: This randomized phase III trial is studying donor bone marrow transplant with or without G-CSF to compare how well they work in treating young patients with hematologic cancer or other diseases.
Condition | Intervention | Phase |
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Leukemia Myelodysplastic Syndromes |
Procedure: allogeneic bone marrow transplantation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Official Title: | A Phase III Randomized Trial of G-CSF Stimulated Bone Marrow vs. Conventional Bone Marrow as a Stem Cell Source in Matched Sibling Donor Transplantation |
Estimated Enrollment: | 425 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients undergo filgrastim (G-CSF)-stimulated allogeneic BMT on day 0.
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Procedure: allogeneic bone marrow transplantation
Patients undergo allogeneic BMT on day 0
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Arm II: Active Comparator
Patients undergo conventional allogeneic BMT on day 0.
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Procedure: allogeneic bone marrow transplantation
Patients undergo allogeneic BMT on day 0
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk (high vs intermediate vs standard).
Conditioning regimen:
Graft-vs-host disease (GVHD) prophylaxis:
Allogeneic bone marrow transplantation (BMT): Patients are randomized to 1 of 2 transplantation arms.
PROJECTED ACCRUAL: A total of 425 patients will be accrued for this study.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of hematologic cancer or other disease, including any of the following:
Acute lymphoblastic leukemia (ALL), meeting any of the following criteria:
Very high-risk ALL in first CR, defined as any of the following:
Acute myeloid leukemia in first or second CR
Matched sibling donor must be available
PATIENT CHARACTERISTICS:
FEV_1, FVC, and DLCO ≥ 60% OR meets the following criteria (for patients unable to cooperate for pulmonary function tests):
No known uncontrolled fungal, bacterial, or viral infections
PRIOR CONCURRENT THERAPY:
Study Chair: | Stephen A. Grupp, MD, PhD | Children's Hospital of Philadelphia |
Investigator: | Haydar Frangoul, MD | Vanderbilt-Ingram Cancer Center |
Study ID Numbers: | CDR0000532926, COG-ASCT0631, COG-PBMTC-STC051 |
Study First Received: | March 20, 2007 |
Last Updated: | January 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00450450 |
Health Authority: | United States: Federal Government |
juvenile myelomonocytic leukemia childhood acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission recurrent childhood acute lymphoblastic leukemia childhood chronic myelogenous leukemia |
chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes childhood myelodysplastic syndromes |
Juvenile myelomonocytic leukemia Myelodysplastic syndromes Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Chronic myelogenous leukemia Precancerous Conditions Hematologic Neoplasms Hematologic Diseases Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia |
Leukemia, Myeloid Leukemia, Myelomonocytic, Juvenile Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid, Acute Recurrence Leukemia Preleukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Neoplasm Metastasis Bone Marrow Diseases Acute myelocytic leukemia |
Neoplasms Pathologic Processes Disease Neoplasms by Histologic Type Syndrome |