Donor Bone Marrow Transplant With or Without G-CSF in Treating Young Patients With Hematologic Cancer or Other Diseases

This is an interventional treatment trial for Childhood Acute Lymphoblastic Leukemia in Remission Read More

Inclusion Criteria:

• 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 ≥ 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 (< 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
• 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
• Karnofsky performance status (PS) 60-100% (patients > 16 years of age) OR Lansky PS 60-100% (patients ≤ 16 years of age)
• AST or ALT < 5 times upper limit of normal for age
• Bilirubin < 2.5 mg/dL (unless due to Gilbert's syndrome)

• Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR serum creatinine base on age and/or gender as follows:

  • 0.4 mg/dL (1 month to < 6 months of age)
  • 0.5 mg/dL (6 months to < 1 year of age)
  • 0.6 mg/dL (1 to 2 years of age)
  • 0.8 mg/dL (2 to < 6 years of age)
  • 1.0 mg/dL (6 to < 10 years of age)
  • 1.2 mg/dL (10 to < 13 years of age)
  • 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 to < 16 years of age)
  • 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age)
• Shortening fraction ≥ 27% by echocardiogram OR LVEF ≥ 50% by radionuclide angiogram

• FEV_1, FVC, and DLCO ≥ 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
• No prior allogeneic or autologous stem cell transplantation