Anti-Third Party T Lymphocytes With Nonmyeloablative Stem Cell Transplantation for Indolent Lymphoid Malignancies

Stopped early · Phase 1

Conditions studied: Leukemia, Lymphoma, Myeloma

In brief

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) at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells. Secondary Objective: 1\. Toxicity, response rate, time to progression and overall survival.

Key facts

Study ID

NCT00473551

Run by

M.D. Anderson Cancer Center

People needed

4

Starts

2007-05-01

Expected to finish

2009-11-01

Last updated by the study team

2011-12-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• U.T.M.D. Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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