NCT00024050

Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome

Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation for the Treatment of "Less Advanced" Myelodysplasi

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelodysplastic syndrome.

Detailed description

OBJECTIVES: * Determine the non-relapse toxicity and mortality on day 100 and at 1 year after transplantation in patients with low or intermediate-risk myelodysplastic syndrome treated with busulfan, cyclophosphamide, and allogeneic peripheral blood stem cell transplantation. * Determine the incidence of donor stem cell engraftment and relapse-free survival in these patients treated with this regimen. * Determine the incidence and severity of acute and chronic graft-versus-host disease and invasive fungal infections in these patients treated with this regimen. * Determine the incidence of relapse in these patients treated with this regimen. OUTLINE: Peripheral blood stem cells (PBSC) or bone marrow are harvested from a related or unrelated compatible donor. PBSC are selected for CD34+ cells. Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV on days -3 and -2. Allogeneic PBSC or bone marrow is infused on day 0. As graft-versus-host disease prophylaxis, patients receive cyclosporine IV beginning on day -1 and continuing orally twice daily (if feasible) until day 51 followed by a taper. Patients also receive methotrexate IV on days 1, 3, 6, and 11. Patients are followed through day 100, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 3 years.

Conditions

• Leukemia
• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	busulfan
DRUG	cyclophosphamide
DRUG	cyclosporine
DRUG	methotrexate
PROCEDURE	allogeneic bone marrow transplantation
PROCEDURE	peripheral blood stem cell transplantation

Timeline

• Start date: 2001-02-01
• Completion: 2007-08-01
• First posted: 2003-01-27
• Last updated: 2010-05-13

Locations

1 site across 1 country: United States