COG ASCT0631/PBMTC STC051 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
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.
Ages Eligible for Study: up to 21 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Diagnosis of hematologic cancer or other disease, including any of the following: Chronic myelogenous leukemia in first or second chronic phase Acute lymphoblastic leukemia (ALL), meeting any of the following criteria: Relapsed ALL enrolled on a Children's Oncology Group (COG) relapse clinical trial OR received â?¥ 1 round of reinduction therapy (4-6 weeks) and 1 round of intensive consolidation chemotherapy (3-6 weeks) ALL in second complete remission (CR)* after a bone marrow, extramedullary, or combined bone marrow and extramedullary relapse Very high-risk ALL in first CR, defined as any of the following: Philadelphia chromosome-positive ALL Hypodiploidy ( less than 44 chromosomes) Mixed lineage leukemia rearrangement Induction failure Acute myeloid leukemia in first or second CR Induction therapy must be completed Juvenile myelomonocytic leukemia Myelodysplastic syndromes NOTE: *As evidenced by M1 bone marrow and less than 5% blasts by morphology No clinically evident CNS or extramedullary disease No blasts seen on cerebrospinal fluid cytospin Post-relapse reinduction therapy must be completed Not planning to receive reduced-intensity conditioning regimen Not planning to receive a graft that has undergone T-cell depletion No Down syndrome Matched sibling donor must be available and must be enrolled on ASCT0631D companion study PATIENT CHARACTERISTICS: Karnofsky performance status (PS) 60-100% (patients greater than 16 years of age) OR Lansky PS 60-100% (patients â?¤ 16 years of age) AST or ALT less than 5 times upper limit of normal for age Bilirubin less than 2.5 mg/dL (unless due to Gilbert's syndrome) Creatinine clearance or radioisotope glomerular filtration rate â?¥ 70 mL/min OR serum creatinine base on age and/or gender as follows: 0.4 mg/dL (1 month to less than 6 months of age) 0.5 mg/dL (6 months to less than 1 year of age) 0.6 mg/dL (1 to 2 years of age) 0.8 mg/dL (2 to less than 6 years of age) 1.0 mg/dL (6 to less than 10 years of age) 1.2 mg/dL (10 to less than 13 years of age) 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to less than 16 years of age) 1.7 mg/dL (male) or 1.4 mg/dL (female) (â?¥ 16 years of age) Shortening fraction â?¥ 27% by echocardiogram OR LVEF â?¥ 50% by radionuclide angiogram FEV_1, FVC, and DLCO â?¥ 60% OR meets the following criteria (for patients unable to cooperate for pulmonary function tests): No evidence of dyspnea at rest No exercise intolerance No requirement for supplemental oxygen therapy Not pregnant or nursing No known HIV No known uncontrolled fungal, bacterial, or viral infections Patients acquiring fungal disease during induction therapy may proceed if they have a significant response to antifungal therapy with no or minimal evidence of disease remaining by CT scan PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior allogeneic or autologous stem cell transplantation
This is a randomized, multicenter study. Patients are stratified according to risk (high vs intermediate vs standard). Conditioning regimen: Co-enrolled on COG-ASCT0431 or COG-AAML0531: Patients receive a conditioning regimen as defined on that treatment study. Acute lymphoblastic leukemia (ALL): Patients undergo total-body irradiation (TBI) twice daily on days -8 to -6. Patients receive thiotepa IV on days -5 and -4 and high-dose cyclophosphamide IV over 1 hour on days -3 and -2. Some patients with CNS leukemia or very high-risk ALL in first complete remission receive cranial radiotherapy. Acute myeloid leukemia, juvenile myelomonocytic leukemia, chronic myelogenous leukemia, or myelodysplastic syndromes (myeloid malignancies): Patients receive busulfan IV over 2 hours every 6 hours on days -9 to -6 and high-dose cyclophosphamide IV over 1 hour on days -5 to -2. Graft-vs-host disease (GVHD) prophylaxis: Co-enrolled on COG-ASCT0431 or COG-AAML0531: Patients undergo GVHD prophylaxis as defined on that treatment study. ALL: Patients receive tacrolimus IV or orally beginning on day -2 and continuing until day 42, followed by a taper until day 98. Patients also receive methotrexate IV on days 1, 3, and 6. Myeloid malignancies: Patients receive cyclosporine IV continuously or orally beginning on day -1 and continuing until day 42 or day 50, followed by a taper for 8-16 weeks. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Allogeneic bone marrow transplantation (BMT): Patients are randomized to 1 of 2 transplantation arms. Arm I: Patients undergo filgrastim (G-CSF)-stimulated allogeneic BMT on day 0. Arm II: Patients undergo conventional allogeneic BMT on day 0. After completion of study treatment, patients are followed at 1 year and then annually for 5-10 years
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