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

• Status: Terminated
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

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) at 90 days after allogeneic transplantation of CD34+ hematopoietic progenitor cells.

Secondary Objective:

1. Toxicity, response rate, time to progression and overall survival.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Cyclophosphamide; Everolimus; Fludarabine; Fludarabine phosphate; Rituximab; Sirolimus; Vidarabine

Criteria

Inclusion Criteria:

• 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 Exclusion Criteria:

• 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.