CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0227 (clinicaltrials.gov NCT No: NCT00809276)
Title:Multi-institutional Trial of Allogeneic Bone Marrow Transplantation 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.
Principal Investigator:Richard E. Champlin
Treatment Agent:Busulfan; Cyclophosphamide; Fludarabine; Mesna; Mycophenolate Mofetil; Tacrolimus
Study Status:Closed
Study Description:The goal of this part of the clinical research study is to learn if there are
immune components in your blood that may affect the development and/or severity
of graft versus host disease (GVHD - a condition in which transplanted tissue
attacks the transplant recipient's body) in your family member who will receive
your stem cells.

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Disease Group:Leukemia; Lymphoma; Myeloma
Phase of Study:Phase II
Treatment Agents:Busulfan
Cyclophosphamide
Fludarabine
Mesna
Mycophenolate Mofetil
Tacrolimus
Treatment Location:Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions
Estimated Length of Stay in Houston:Patients are expected to be hospitalized for 5-6 weeks for the transplant.
After discharge there is no planned admission unles clinically indicated.
Supported By:Otsuka Pharmecuticals
Return Visit:This protocol calls for weekly assesment after discharge during the first 100
days post-transplant. Patients are to return 6 and 12 months after transplant.
However, return visits may occur more frequently as clinically indicated.
Home Care:There is no home care as part of this study.


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Physician Name:Richard E. Champlin
Dept:Stem Cell Transplantation and Cellular Therapy
For Clinical Trial Enrollment:713-792-8750
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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