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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01840566
First received: April 23, 2013
Last updated: June 12, 2014
Last verified: June 2014

April 23, 2013
June 12, 2014
April 2013
April 2015   (final data collection date for primary outcome measure)
  • maximum tolerated dose (MTD) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    will be assessed utilizing a standard 3+3 cell dose escalation to determine the maximum tolerated dose of CD19+ CAR T cells
  • safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Toxicity will be graded on a scale of 1 to 5 as described by the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
Same as current
Complete list of historical versions of study NCT01840566 on ClinicalTrials.gov Archive Site
  • 2 year progression-free (PFS) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • overall survival (os) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
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).

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Non-Hodgkin's Lymphoma
  • Drug: Carmustine
  • Drug: Etoposide
  • Drug: Cytarabine
  • Drug: Melphalan
  • Biological: Pegfilgrastim
  • Biological: 19-28z T CELLS
  • Procedure: Autologous Stem Cell Transplantation
Experimental: HIGH DOSE CHEMOTHERAPY AND ASCT
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.
Interventions:
  • Drug: Carmustine
  • Drug: Etoposide
  • Drug: Cytarabine
  • Drug: Melphalan
  • Biological: Pegfilgrastim
  • Biological: 19-28z T CELLS
  • Procedure: Autologous Stem Cell Transplantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
18
April 2015
April 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Craig Sauter, MD 212-639-3460
Contact: Jenna Goldberg, MD 212-639-4828
United States
 
NCT01840566
12-117
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Craig Sauter, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP