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
Conditions
Non-Hodgkin's Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, B-Cell - Lymphoma, Non-Hodgkin
Conditions: Keywords
Relapsed, Refractory, Autologous Stem Cell Transplantation, HIGH DOSE CHEMOTHERAPY, 19-28z T cells/kg, 12-117
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Carmustine Type: Drug
Name: Etoposide Type: Drug
Name: Cytarabine Type: Drug
Name: Melphalan Type: Drug
Name: Pegfilgrastim Type: Biological
Name: 19-28z T CELLS Type: Biological
Name: Autologous Stem Cell Transplantation Type: Procedure
Overall Status
Recruiting
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).
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Transplant eligible patients will be eligible if criteria met per below.

Inclusion Criteria:

- Patients > or = to 18 years of age with aggressive B-cell non-Hodgkin lymphoma subtypes including, but not limited to, relapsed or refractory diffused large B-cell lymphoma (DLBCL), Burkitt's lymphoma or transformed indolent B-cell non-Hodgkin lymphoma (including chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL) 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, 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 hemoglobin.

- Life expectancy of > 3 months.

Exclusion Criteria:

- Karnofsky performance status < or = to 70 (see appendix VI).

- Patients previously treated with 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.
Location
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Status: Recruiting
Contact: Craig Sauter, MD - 212-639-3460
Start Date
April 2013
Completion Date
April 2016
Sponsors
Memorial Sloan Kettering Cancer Center
Source
Memorial Sloan Kettering Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page