NCT00002792

Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders

ALLOGENEIC MARROW OR PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR AGNOGENIC MYELOID METAPLASIA WITH MYELOFIBROSIS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• 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 tumor cells from dividing so they stop growing or die. Combining bone marrow or peripheral stem cell transplantation with chemotherapy may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus either bone marrow or peripheral stem cell transplantation in treating patients with myeloproliferative disorders.

Detailed description

OBJECTIVES: * Assess disease free survival in patients with idiopathic myelofibrosis treated with a preparative busulfan/cyclophosphamide regimen followed by allogeneic bone marrow or peripheral blood stem cell transplantation. * Determine the risk of primary graft failure in these patients. OUTLINE: Patients receive a preparative regimen consisting of oral busulfan every 6 hours on days -7 through -4 and cyclophosphamide on days -3 and -2. Patients then receive allogeneic bone marrow or peripheral blood stem cells on day 0. Patients registered on protocol FHCRC-1106.00 randomized to stem cell transplant receive unmodified G-CSF-mobilized stem cells from an HLA-identical donor. Patients receive cyclosporine/methotrexate or tacrolimus/methotrexate as prophylaxis for graft-versus-host disease (GVHD). Patients receiving marrow from unrelated donors are eligible for appropriate GVHD prophylaxis studies. Patients are followed at 6 and 12 months after transplant. PROJECTED ACCRUAL: A maximum of 20 patients will be accrued for this study over approximately 3.5 years.

Conditions

• Chronic Myeloproliferative Disorders
• Leukemia
• Myelodysplastic/Myeloproliferative Diseases

Interventions

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

Timeline

• Start date: 1996-06-01
• Primary completion: 2003-04-01
• Completion: 2003-04-01
• First posted: 2003-01-27
• Last updated: 2010-04-02

Locations

1 site across 1 country: United States