Status:
COMPLETED
Allogeneic Blood Stem Cell Transplantation
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Hodgkin's Disease
Eligibility:
All Genders
Up to 65 years
Phase:
NA
Brief Summary
1. To determine the feasibility and toxicity of employing allogeneic peripheral blood stem cell transplantation after intensive but non-myeloablative chemotherapy in patients with relapsed Hodgkin's d...
Detailed Description
All patients in this study must have a plastic tube (catheter) inserted into a vein under the collarbone. Drugs and stem cells will be given through this tube. Fludarabine will be given through the c...
Eligibility Criteria
Inclusion
- Patients \<65 years of age with histologically confirmed primary refractory or relapsed Hodgkin's disease. In the event of transplants from unrelated donors, the upper age limit will be 55 years.
- Patients who failed or relapsed after an autologous transplant are eligible.
- Patients should have responsive or stable disease on salvage chemotherapy. Patients with untreated, smoldering (i.e. not rapidly progressive) relapses are eligible. Patients who failed or relapsed after an autologous transplant are eligible.
- Patients must have a serum bilirubin \<2.0 mg/dl, serum creatinine \<2.0 mg/dl, no symptomatic cardiac or pulmonary disease and a PS\<2. Life expectancy not severely limited by concomitant illness (\>12 weeks). Left ventricular ejection fraction \>50%.
- Patients must have an HLA-compatible donor (one-antigen mismatched related donors are acceptable) willing to donate marrow or rhG-CSF-mobilized peripheral blood stem cells . In the event of transplants from unrelated donors, only fully serologically A-, B- and DR-matched donors (including donors having a single micromismatch by DR/DQ molecular typing) will be acceptable. HLA-compatible cord blood unit will also be acceptable for recipient with a body weight of 50 kg or less.
Exclusion
- Patients with documented disease progression on salvage chemotherapy are not eligible.
- Uncontrolled arrhythmia or symptomatic cardiac disease. FEV1, FVC and DLCO less than 50% . Symptomatic pulmonary disease. Evidence of chronic active hepatitis or cirrhosis.
- Active or uncontrolled infection.
Key Trial Info
Start Date :
January 1 1998
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00423709
Start Date
January 1 1998
End Date
August 1 2007
Last Update
January 24 2012
Active Locations (1)
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1
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030