Infusion of Allogeneic CD19-Specific T Cells From Peripheral Blood (NCT01497184) | Clinical Trial Compass
CompletedPhase 1
Infusion of Allogeneic CD19-Specific T Cells From Peripheral Blood
United States95 participantsStarted 2011-12
Plain-language 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. The process of changing the DNA (the genetic material in cells) of these T-cells is called "gene transfer." Researchers want to learn if these genetically-changed T-cells are effective in attacking cancer cells in patients with advanced B-cell lymphoma or leukemia, after they have received standard allogeneic HSCT. Researchers want to find out the highest dose of these special T-cells that can be given safely to leukemia and lymphoma patients. Researchers also want to learn how long the changed T-cells stay in your body, and if adding them to standard transplant can improve how you respond to treatment.
Who can participate
Age range1 Year – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓
What they're measuring
1
Maximum Tolerated dose (MTD) of Donor Lymphocyte Infusion (DLI)
. 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 criteria
✕. 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.