NCT00343785

Cyclophosphamide and Anti-thymocyte Globulin Followed By Methotrexate and Cyclosporine in Preventing Chronic Graft-Versus-Host Disease in Patients With Severe Aplastic Anemia Undergoing Donor Bone Marrow Transplant

Cyclophosphamide and Antithymocyte Globulin Conditioning Regimen for Marrow Transplantation From HLA-Matched Family Members for Severe Aplastic Anemia: Effect of Marrow Cell Dose on Chronic Graft-vs.-Host Disease: A Multi-Center Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is studying how well giving cyclophosphamide together with anti-thymocyte globulin followed by methotrexate and cyclosporine works in preventing chronic graft-vs-host disease (GVHD) in patients with severe aplastic anemia undergoing donor bone marrow transplant. Giving low doses of chemotherapy, such as cyclophosphamide, before a donor bone marrow transplant helps stop the growth of abnormal cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining abnormal cells. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving anti-thymocyte globulin before and methotrexate and cyclosporine after transplant may stop this from happening

Detailed description

PRIMARY OBJECTIVES: I. Minimize the incidence of chronic GVHD by restricting the transplanted marrow dose to 2.0-2.5 x 10\^8 nucleated cells/kg. SECONDARY OBJECTIVES: I. Engraftment and overall survival. OUTLINE: CONDITIONING REGIMEN: Patients receive cyclophosphamide intravenously (IV) on days -5 to -2 and anti-thymocyte globulin IV over 4-10 hours on days -4 to -2. TRANSPLANTATION: Patients undergo allogeneic bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive methotrexate IV on days 1, 3, 6, and 11 and cyclosporine IV over 1 hour or orally (PO) twice daily on days -1 to 50, followed by a taper until 6 months after grafting. After completion of study treatment, patients are followed up at on day 180, 1 year, 1.5 years, 2 years, 3 years, and yearly thereafter.

Conditions

• Aplastic Anemia

Interventions

Type	Name	Description
DRUG	cyclophosphamide	Given IV
BIOLOGICAL	anti-thymocyte globulin	Given IV
DRUG	cyclosporine	Given IV or PO
PROCEDURE	allogeneic bone marrow transplantation	Undergo allogeneic bone marrow transplantation
DRUG	methotrexate	Given IV
GENETIC	DNA analysis	Correlative studies
OTHER	flow cytometry	Correlative studies
GENETIC	polymorphism analysis	Correlative studies
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2006-02-01
• Primary completion: 2012-05-01
• Completion: 2012-08-01
• First posted: 2006-06-23
• Last updated: 2017-04-13
• Results posted: 2017-03-16

Locations

3 sites across 1 country: United States