Infusion of Allogeneic CD19-Specific T Cells From Peripheral Blood
Leukemia, Lymphoma
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Leukemia, Lymphoma, Allogeneic donor lymphocyte infusion, DLI, Hematopoietic Stem Cell Transplantation, HSCT, Bone marrow transplant, CD19-specific T cells, T cell infusion, B-Lineage lymphoid malignancies, CD19+ lymphoid malignancies, Acute lymphoblastic leukemia, ALL, Biphenotypic leukemia CD19+ in advanced remission, Non-Hodgkin's Lymphoma, NHL, Diffuse large B-cell lymphoma, Small lymphocytic lymphoma, Follicular lymphoma, Mantle cell lymphoma with active disease at time of transplant
Eligibility Criteria
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.
- 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.
- Active CNS disease in patient with history of CNS malignancy.
- Positive serology for HIV.
Sites / Locations
- University of Texas MD Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
DLI (Adults)
DLI any time
DLI Pediatrics
DLI - Haplo-Identical Family Donor
Arm 1: Allogeneic donor lymphocyte infusion (DLI) starting dose not to exceed 10^6/m^2 intravenously (IV) between 6 weeks - 12 weeks following date of allogeneic hematopoietic stem-cell transplantation (HSCT) as a planned DLI.
Arm 2: DLI will be administered at any point after disease recurrence following HSCT.
Arm 3: DLI administered intravenously between 6 weeks and 12 weeks following date of HSCT as a planned DLI in pediatric patients, aged 1-17 years-old.
Arm 4: DLI administered as planned DLI or after recurrence in adult and pediatric patients undergoing transplant with a haplo-identical family donor.