CD19-specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies
Lymphoma, B-cell Lymphoma
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring CD19+ lymphoid malignancies, non-Hodgkin's Lymphoma, NHL, small lymphocytic lymphoma, SLL, follicular lymphoma, mantle cell lymphoma, gene cell transfer, CD19-specific T cells, Stem Cell Transplant, T Cell Infusion, Chemotherapy, Leukapheresis, BCNU, carmustine, Cytarabine, Etoposide, Interleukin-2, Proleukin, Melphalan, Rituximab, T cell therapy
Eligibility Criteria
Inclusion Criteria:
- Patients with a history of CD19+ lymphoid malignancies that are beyond first remission or primary refractory to treatment.
- Age 18 to 75 years.
- Zubrod performance 0-1 or Karnofsky greater than or equal to 80%.
- Patient able to provide written informed consent.
- Patient able to provide written informed consent for the long-term follow-up gene therapy study.
- Eligibility at time of transplant conditioning regimen (criteria 6-13): Zubrod performance 0-1 or Karnofsky greater than or equal to 80%.
- Left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
- No symptomatic pulmonary disease. FEV1, FVC and DLCO >/= 50% of expected, corrected for hemoglobin.
- Serum creatinine </= 1.8mg/dL or creatinine clearance >/= 40 cc/min.
- Adequate hepatic function, as defined by SGPT <3 X upper limit of normal; serum bilirubin and alkaline phosphatase <2 X upper limit of normal, or considered not clinically significant.
- If positive Hepatitis B and/or Hepatitis C serology, discuss with Principal Investigator or designee and consider liver biopsy.
- No pleural/pericardial effusion or ascites estimated to be >1L.
- Not breast feeding or pregnant. Pregnancy determined by a positive beta HCG test in a woman with child bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Eligibility at time of T-cell infusion (criteria 14-15): No systemic corticosteroids within 3 days prior to T-cell infusion.
- Not experiencing any new Grade >2 (CTC version 4) adverse neurologic, pulmonary, cardiac, gastrointestinal, renal or hepatic (excluding albumin) event within 24 hours prior to T-cell infusion.
- Eligibility criteria for administration of IL-2 after T-cell infusion: Absence of new adverse event of grade >2 (CTC vs. 4) involving cardiopulmonary, hepatic (excluding albumin), gastrointestinal, neurologic, or renal toxicity probably or definitely attributed to infused T cells within one week of cells.
Exclusion Criteria:
- Positive beta HCG in female of child-bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
- Patients with known allergy to bovine or murine products.
- Positive serology for HIV.
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
CD19-specific T cell Infusion without IL-2
CD19-specific T cell Infusion with IL-2
Conditioning Regimen of Chemotherapy (Carmustine, Cytarabine, Etoposide, and Melphalan), Stem Cell Transplant, and Gene Transfer Group 1 - low dose of T cells without IL-2. Group 3 - higher dose of T cells without IL-2.
Conditioning Regimen of Chemotherapy (Carmustine, Cytarabine, Etoposide, and Melphalan), Stem Cell Transplant, and Gene Transfer Group 2 - higher dose of T cells with IL-2. Group 4 - higher dose of T cells with IL-2.