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



Status:Active, not recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/28/2017
Start Date:April 2013
End Date:April 2018

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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

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).


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.
We found this trial at
1
site
1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Craig Sauter, MD
Phone: 212-639-3460
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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