Non Hodgkin Lymphoma Clinical Trial
High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma
Summary
The purpose of this study is to test the safety of delivering the patients' own immune cells, called T cells, after the high-dose chemotherapy (HDT) and autologous stem cell transplantation (ASCT).
Eligibility Criteria
Transplant eligible patients will be eligible if criteria met per below.
Inclusion Criteria:
Patients ≥ 18 years of age with aggressive B-cell non-Hodgkin lymphoma subtypes including, relapsed or refractory diffused large B-cell lymphoma (DLBCL), and transformed follicular lymphoma meeting at least one of the following criteria:
Bone marrow involvement at the time of relapse or refractory disease and not appropriate for allogeneic transplantation.
PET positive disease outside of one radiation port unless single-port disease treated with prior radiotherapy within the port, following > or = to 2 cycles of salvage chemotherapy, still achieving chemosensitive status 1999 IWG criteria (section 12.2 and 12.383).
Creatinine ≤ 1.5 mg/100 ml (or measured 24 hour creatinine clearance of ≥ 50 cc/min)
Bilirubin <2.0 mg/100 ml, AST and ALT <3x the upper-limit of normal, PT and PTT < 2x normal outside the setting of stable chronic anticoagulation therapy,
Adequate cardiac function (LVEF>40%) as assessed by ECHO or MUGA scan performed within 1 month of treatment.
Adequate pulmonary function as assessed by DLCO of > or = to 45% adjusted for hemoglobin.
Life expectancy of > 3 months.
Exclusion Criteria:
Karnofsky performance status ≤ 70 (see appendix VI).
Patients with other aggressive B-cell malignancies including, but not limited to: Burkitt lymphoma, transformed CLL/SLL and transformed marginal zone lymphoma that are not included in 6.1 inclusion criteria.
Patients previously treated with autologous or allogeneic bone marrow or stem cell transplantation are ineligible.
Other past or current malignancy unless in the opinion of the investigator it does not contraindicate participation in the study.
Uncontrolled bacterial, viral or fungal infection.
Patients with HIV, active hepatitis B or hepatitis C infection.
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There are 7 Locations for this study
Basking Ridge New Jersey, 07920, United States
Middletown New Jersey, 07748, United States
Montvale New Jersey, 07645, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Rockville Centre New York, 11553, United States
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