Status:
COMPLETED
Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Conditions:
Lymphoma
Leukemia
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to find out if giving a boost of natural killer (NK) cells from a donor combined with Rituxan (rituximab), can help to control disease in patients who have ...
Detailed Description
Rituximab is designed to attach to lymphoma cells, causing them to die. GM-CSF and NK cells may increase rituximab's ability to kill these cells. Before you can start treatment on this study, you wil...
Eligibility Criteria
Inclusion
- Patients with previous diagnosis of CD20+ B-cell CLL and non-Hodgkin's lymphoma who have failed standard conventional chemotherapy, and who had persistent disease at 3 months, or progressive disease after non-myeloablative allogeneic transplantation.
- Donor willingness to donate peripheral blood (same donor of the original transplant).
- Negative Beta HCG in a woman with child bearing potential defined as not post-menopausal for 12 months or not previous surgical sterilization.
Exclusion
- Pregnancy or lactation
- HIV , HTLV-I or hepatitis.
- Active infection(s) \>/= grade 3.
- Severe active concomitant medical or psychiatric illness.
- Concurrent active GVHD requiring tacrolimus.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 22 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00383994
Start Date
September 1 2006
End Date
July 22 2019
Last Update
July 31 2019
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030