NCT00809276

Allo BMT Using Matched Related/Unrelated Donors With FluBu and HiCY

Trial of Allogeneic BMT for Hematologic Malignancies Using HLA-matched Related or Unrelated Donors With Fludarabine and IV Busulfan as Pre-transplant Conditioning Followed by Post-transplant Immunosuppression With High-dose Cyclophosphamide

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research is to find the most effective and least toxic way to prevent GVHD after BMT.

Detailed description

A person who has cancer of the blood or lymph glands can be treated by bone marrow transplantation (BMT). BMT has developed over several decades of research on both animal and human subjects as an effective treatment of various malignant and nonmalignant hematologic diseases. Many hematologic malignancies can be successfully treated with a combination of high-dose chemotherapy or chemo-radiotherapy and transplantation of allogeneic bone marrow or peripheral blood stem cells (alloBMT) However, a possible side effect of BMT is graft versus host disease (GVHD). GVHD occurs when cells of the donor's immune system, which are present in the bone marrow, attack the BMT recipient's normal tissue. Prevention of GVHD is important for the success of the bone marrow transplant. This research is being done to find the most effective and least toxic way to prevent GVHD after BMT

Conditions

• Lymphoma
• Multiple Myeloma
• Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Busulfan, Fludarabine, Cytoxan	Busulfan once a day for 4 days Fludarabine once a day for 4 days Bone marrow transplant Cytoxan two doses

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2008-12-17
• Last updated: 2015-02-16
• Results posted: 2015-01-19

Locations

3 sites across 1 country: United States