NCT00521430

Donor Stem Cell Transplant After Conditioning Therapy in Treating Patients With Hematologic Cancer, Recurrent or Metastatic Solid Tumor, or Other Disease

NON-T-CELL DEPLETED HLA-HAPLOIDENTICAL FAMILIAL DONOR HEMATOPOIETIC CELL TRANSPLANTATION AFTER REDUCED INTENSITY CONDITIONING

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and methotrexate before and after transplant may stop this from happening. PURPOSE: This clinical trial is studying the side effects and how well donor stem cell transplant works when given after conditioning therapy in treating patients with hematologic cancer, recurrent or metastatic solid tumor, or other disease.

Detailed description

OBJECTIVES: * Determine the safety and efficacy of non-T-cell depleted, HLA-haploidentical related donor hematopoietic stem cell transplantation after a reduced-intensity conditioning regimen comprising busulfan, fludarabine phosphate, anti-thymocyte globulin, and methylprednisolone in patients with hematologic cancer, recurrent or metastatic solid tumors, or other diseases. OUTLINE: * Reduced-intensity conditioning regimen: Patients receive busulfan IV 4 times daily on days -7 and -6; fludarabine phosphate IV over 30 minutes on days -7 to -2; and methylprednisolone IV over 30 minutes followed by anti-thymocyte globulin IV over 4 hours on days -4 to -1. * Donor hematopoietic stem cell transplantation: Patients receive donor peripheral blood stem cells IV over 1 hour on days 0 and 1. * Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV over 2-4 hours or orally twice daily beginning on day -1 and continuing until day 60, followed by a taper in the absence of GVHD. Patients also receive methotrexate IV on days 2, 4, 7, and 12. After the transplant, patients are followed periodically.

Conditions

• Leukemia
• Lymphoma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Nonmalignant Neoplasm
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
BIOLOGICAL	anti-thymocyte globulin
DRUG	busulfan
DRUG	cyclosporine
DRUG	fludarabine phosphate
DRUG	methotrexate
DRUG	methylprednisolone
PROCEDURE	allogeneic hematopoietic stem cell transplantation
PROCEDURE	peripheral blood stem cell transplantation

Timeline

• Start date: 2004-04-01
• Primary completion: 2008-05-01
• Completion: 2008-09-01
• First posted: 2007-08-27
• Last updated: 2013-03-26

Locations

1 site across 1 country: South Korea