Overview

This trial is active, not recruiting.

Condition non-hodgkin's lymphoma
Treatments carmustine, etoposide, cytarabine, melphalan, pegfilgrastim, 19-28z t cells, autologous stem cell transplantation
Phase phase 1
Sponsor Memorial Sloan Kettering Cancer Center
Start date April 2013
End date April 2017
Trial size 17 participants
Trial identifier NCT01840566, 12-117

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This is a phase 1 dose escalation study designed to determine the maximum tolerated dose (MTD) of CAR modified T cells in patients with relapsed and refractory aggressive B-NHL. Three dose levels (5 x 106 19-28z T cells/kg, 1 x 107 19-28z T cells/kg, and 2 x 107 19-28z T cells/kg) are considered for the MTD.
carmustine
etoposide
cytarabine
melphalan
pegfilgrastim
19-28z t cells
autologous stem cell transplantation

Primary Outcomes

Measure
maximum tolerated dose (MTD)
time frame: 2 years
safety
time frame: 2 years

Secondary Outcomes

Measure
2 year progression-free (PFS)
time frame: 2 years
overall survival (os)
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title 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
Principal investigator Craig Sauter, MD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.
Location data was received from the National Cancer Institute and was last updated in September 2016.