Status:
WITHDRAWN
Infusion of Allogeneic, 3rd Party CD19-specific T Cells
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Blood And Marrow Transplantation
Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to learn if researchers can successfully and safely give patients who have had a stem cell transplant an infusion of white blood cells (called T-cells) that...
Detailed Description
Study Plan: This study has 2 steps: chemotherapy and gene transfer. The chemotherapy combination in this study (fludarabine and cyclophosphamide) is given to try to help the T-cells work better. St...
Eligibility Criteria
Inclusion
- Patients with a history of refractory B-cell lymphoid malignancies: 1) acute lymphoblastic leukemia (ALL), CD19+, 2) biphenotypic leukemia CD19+, 3) non-Hodgkin's Lymphoma (NHL), which includes diffuse large B-cell lymphoma, small lymphocytic lymphoma, follicular lymphoma, mantle cell lymphoma, or chronic lymphocytic leukemia (CLL).
- Age 18 to 70 years.
- Zubrod performance 0-2 or Karnofsky greater than or equal to 60%.
- Patient or patient's legal representative able to provide written informed consent.
- Patient or patient's legal representative able to provide written informed consent for the long-term follow-up gene therapy study.
- Patients must be a minimum of 3 months from last hematopoietic stem cell transplant (HSCT) and 3 weeks from last systemic chemotherapy.
Exclusion
- Patients with known allergy to bovine or murine products.
- Clinically significant acute or chronic GVHD requiring systemic immunosuppression, including methylprednisolone \>/= 1 mg/kg/day.
- Systemic corticosteroid use within 72 hours of treatment initiation.
- Antibody to HLA expressed on 3rd party T cells.
- Experiencing any new Grade \>2 (CTC version 4) adverse neurologic, pulmonary, cardiac, gastrointestinal, renal or hepatic (excluding albumin) event within 24 hours prior to treatment initiation.
- Active infection defined as positive culture, if available, for bacteria, fungus, or virus within a 3-day period prior to treatment initiation and/or fever greater than 38°C within 24 hours prior to treatment initiation.
- Positive beta HCG by qualitative pregnancy test in female of child-bearing potential defined as not post menopausal for 12 months or absence of previous surgical sterilization.
Key Trial Info
Start Date :
October 20 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02274506
Start Date
October 20 2014
End Date
October 20 2014
Last Update
January 22 2020
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