Sibling Donor Peripheral Stem Cell Transplant or Sibling Donor Bone Marrow Transplant in Treating Patients With Hematologic Cancers or Other Diseases

• Time to treatment failure (extensive chronic graft-versus-host disease [GVHD], relapse, death) [ Designated as safety issue: No ]
  

• Time to neutrophil recovery [ Designated as safety issue: No ]
  
• Primary graft failure [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  
• Quality of life [ Designated as safety issue: No ]
  
• Time to acute GVHD [ Designated as safety issue: No ]
  
• Time to chronic GVHD [ Designated as safety issue: No ]
  
• Chronic GVHD details [ Designated as safety issue: No ]
  
• Cost [ Designated as safety issue: No ]
  
• Detailed donor and patient self-reported outcomes [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Compare the time to treatment failure in patients with hematologic malignancies or other diseases treated with filgrastim (G-CSF)-mobilized matched-sibling donor peripheral blood stem cell transplantation vs G-CSF-stimulated matched-sibling donor bone marrow transplantation.

Secondary

• Compare the hematological recovery and overall survival of patients treated with these regimens.
• Compare the quality of life, in terms of extensive graft-versus-host disease (GVHD), in patients treated with these regimens.
• Compare the economic impact associated with these treatment regimens.

Tertiary

• Compare the incidence and severity of acute GVHD in patients treated with these regimens.
• Compare organ involvement, symptomatology, and functional impact of chronic GVHD in patients treated with these regimens.
• Compare disease-free survival of patients treated with these regimens.
• Compare donor quality of life.
• Compare cost analysis, from a societal perspective, of these treatment regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to treatment center, disease (chronic myelogenous leukemia vs acute myeloid leukemia vs myelodysplastic syndromes vs other hematologic malignancy), disease stage (early disease vs late disease), and conditioning regimen (busulfan and cyclophosphamide vs cyclophosphamide and total body irradiation vs other).

• Myeloablative conditioning regimen: Patients receive a myeloablative conditioning regimen that has been approved by the clinical chair.

• Stem cell transplantation (SCT): Patients are randomized to 1 of 2 SCT arms.

  • Arm I: Patients undergo sibling donor filgrastim (G-CSF)-mobilized peripheral blood SCT on day 0.
  • Arm II: Patients undergo sibling donor G-CSF- mobilized bone marrow transplantation on day 0.
• Graft-verus-host disease (GVHD) treatment: Patients receive methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV (or orally) every 12 hours beginning on day -2 and continuing until day 100.

Quality of life is assessed at baseline and at 1 and 3 years post-transplantation.

After completion of study therapy, patients are followed periodically for at least 4 years.

PROJECTED ACCRUAL: A total of 230 patients will be accrued for this study.