Autologous and Allogenic Transplantation With Campath-1H for T-Cell Lymphoma
Stopped early · Phase 2
Conditions studied: Lymphoma
In brief
Primary Objectives: 1. To evaluate the role of autologous and allogenic stem cell transplantation with Campath-1H for patients with peripheral T-cell lymphoma (PTCL). 2. To examine the impact of in-vivo purging with Campath -1H pre-autologous stem transplantation for patients with PTCL. 3. To evaluate the impact of soluble CD52 upon in-vivo purging with Campath-1H. 4. To evaluate the role of Campath -1H in the treatment minimal residual disease after autologous transplantation for PTCL.
Key facts
- Study ID
- NCT00505921
- Run by
- M.D. Anderson Cancer Center
- People needed
- 27
- Starts
- 2003-03-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2011-11-16
Who can join
Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be less then 70 years old.
- Patients must have chemosensitive disease, having undergone at least partial remission with less then 10% marrow involvement by gross pathologic examination if autologous transplantation is considered.
- Newly diagnosed patients are eligible for autologous transplant. Patients in relapse would receive a non-myeloablative transplant if a sibling donor is available. Otherwise, patients would undergo autologous transplant if International Prognostic Index (IPI) is 0-1, or unrelated transplant if IPI is > 1.
You may not qualify if…
- Criteria for exclusion are Human immunodeficiency virus (HIV) or Human T-lymphotropic virus (HTLV) seropositivity, pregnancy, cardiac ejection fraction by echo-cardiogram less than 40%, active central nervous system involvement, serum creatinine greater than 1.6 mg/dl or serum bilirubin greater than 1.5 mg/dl unless due to tumor, Absolute neutrophil count (ANC) less than 1,000/mm3 and platelets less than 100,000/mm3 unless due to tumor, performance status (ECOG scale) greater than 2, pulmonary function test- diffusing capacity of the Lung for Carbon Monoxide (DLCO) less than 40% of predicted, and severe concomitant medical or psychiatric illnesses.
Where it is running
- UT MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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