Status:
COMPLETED
Infusion of Allogeneic CD19-Specific T Cells From Peripheral Blood
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Ziopharm Oncology
Conditions:
Leukemia
Lymphoma
Eligibility:
All Genders
1-65 years
Phase:
PHASE1
Brief Summary
The goal of this clinical research study is to learn if researchers can successfully and safely give HSCT patients an infusion of white blood cells (called T-cells) that have been genetically changed....
Detailed Description
Gene Transfer: Gene transfer involves drawing blood from a transplant donor, and then separating out the T-cells using a machine. Researchers then perform a gene transfer to change the T-cells' DNA, ...
Eligibility Criteria
Inclusion
- Patients with a history of CD19+ lymphoid malignancies that are primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease. Patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time:1) Acute Lymphoblastic Leukemia (ALL) with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure,and/or evidence of minimal residual disease, 2) acute biphenotypic leukemia, or 3) double hit nonHodgkin's lymphoma. Non-Hodgkin's Lymphoma (NHL) in second or third complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant). Double hit lymphomas in first remission or more advanced disease. Small Lymphocytic Lymphoma (SLL), or Chronic Lymphocytic Leukemia (CLL) with progressive disease following standard therapy.
- Age 1 to 65 years old.
- Lansky performance score \>/= 60% for patients \</= 16 years of age, or Zubrod performance 0-1 or Karnofsky greater than or equal to 80% for patients \> 16 years of age.
- Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent.
- Patient or patient's legal representative, parent(s) or guardian able to provide written informed consent for the long-term follow-up gene therapy study.
- Patient is planning to receive or has received an HLA-identical matched family, related haploidentical donor (\</= 7/8 allele match), or at least 8/8 matched unrelated allogeneic HSCT.
Exclusion
- Patients with known allergy to bovine or murine products.
- Active grade 2-4 acute GVHD at time of DLI.
- Systemic corticosteroid use within 72 hours of DLI unless required for physiologic replacement.
- Less than 80% donor chimerism from peripheral blood within 30 days of DLI administration, if T cells are made from allogeneic donor.
- Experiencing any new Grade \>2 (CTC version 4) adverse neurologic, pulmonary, cardiac, gastrointestinal, renal or hepatic (excluding albumin) event within 24 hours prior to DLI.
- Currently using an investigational agent at time of DLI.
- Active infection defined as positive culture, if available, for bacteria, fungus, or virus within a 3-day period prior to DLI and/or fever greater than 38°C within 24 hours prior to DLI.
- Positive beta HCG in female of child-bearing potential defined as not post menopausal for 12 months or absence of previous surgical sterilization.
- Active CNS disease in patient with history of CNS malignancy.
- Positive serology for HIV.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2021
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT01497184
Start Date
December 1 2011
End Date
March 8 2021
Last Update
March 13 2025
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030