A Phase I Trial of 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
Transplant eligible patients with relapsed and refractory aggressive B-NHL will be
eligible if criteria met per below.
- Patients > or = to 18 and < or = to 70 years old with relapsed or refractory DLBCL or
transformed B-NHL 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 following > or = to 2 cycles
of salvage chemotherapy, though still achieving chemosensitive status per 1999
IWG criteria (section 12.2 and 12.383).
- Creatinine < or = 1.5 mg/100 ml (or measured 24 hour creatinine clearance of > or =
to 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,
- Granulocytes >1,000/mm3, platelets >50,000/mm3, hemoglobin >8.0g/dl.
- 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
- Life expectancy of > 3 months.
- Karnofsky performance status < or = to 70 (see appendix VI).
- Patients previously treated with allogeneic bone marrow or stem cell transplantation
- 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.