Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
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.
You may not be if
Karnofsky performance status ≤ 70 (see appendix VI).
