Status:
TERMINATED
Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Indolent Lymphoid Malignancies
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Primary Objective: 1\. To determine the maximally tolerated dose of anti-third party cytolytic T-lymphocytes, defined as the dose which achieve engraftment without severe GVHD (graft-vs-host disease)...
Detailed Description
GVHD can be a major problem after stem cell transplantation from a healthy donor. It is caused by T-lymphocytes (a type of immune cell) from the donor that can react badly against the person receiving...
Eligibility Criteria
Inclusion
- Age 18-70
- Confirmed diagnosis of follicular lymphoma, mantle cell lymphoma, chronic lymphocyte leukemia/small lymphocytic lymphoma or multiple myeloma. Patients must have had persistent or progressive disease despite initial chemotherapy. Patients must have achieved a partial or complete response to their most recent chemotherapy.
- Patients must have an human leukocyte antigen (HLA) matched (HLA-A, B, C DR or DQ) related donor who is seropositive against Epstein Barr virus and capable of donating peripheral blood mononuclear cells and peripheral blood progenitor cells.
- Patient must be HLA completely mismatched for HLA class I loci (A, B and C) with the 3rd party stimulator cells. HLA-A (330301, 310102) HLA-B (5801,150101\[62\]) HLA-C (0302, 030301)
- Zubrod Performance Scale (PS) of 0 or 1
- Creatinine \< 1.8 mg/dl
- Ejection fraction \>/=40%
- Corrected Carbon Monoxide Diffusing Capacity (DLCO) \>/=45% predicted
- Serum bilirubin \</=1.5 mg/dl if not due to Gilbert's syndrome
Exclusion
- Uncontrolled infection
- HIV, hepatitis B surface antigen or hepatitis C seropositive
- serum glutamic-pyruvic transaminase (SGPT) \> 200 IU/ml
- Pregnant or lactating women i.e., positive Beta human chorionic gonadotrophin (hCG) test in a woman with child bearing potential. Child bearing potential is defined as not post-menopausal for 12 months or no previous surgical sterilization.
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00473551
Start Date
May 1 2007
End Date
November 1 2009
Last Update
December 19 2011
Active Locations (1)
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1
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030