Infusion of Allogeneic CD19-Specific T Cells From Peripheral Blood
CD19-Specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies After Allogeneic Hematopoietic Stem Cell Transplantation
2 other identifiers
interventional
95
1 country
1
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 leukemia
Started Dec 2011
Longer than P75 for phase_1 leukemia
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 20, 2011
CompletedFirst Posted
Study publicly available on registry
December 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 8, 2021
CompletedMarch 13, 2025
March 1, 2025
9.3 years
December 20, 2011
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated dose (MTD) of Donor Lymphocyte Infusion (DLI)
MTD is highest dose level where 2 of 6 treated participants have dose limiting toxicity (DLT). DLT defined as new adverse event attributable to donor lymphocyte infusion (DLI) grade 3 or \> involving cardiopulmonary, gastrointestinal, hepatic (excluding albumin), neurological, or renal common toxicity criteria (CTC) version 4 parameters, lasts \> 3 days and possibly related to DLI within 30 days of infusion.
3 months
Study Arms (4)
DLI (Adults)
EXPERIMENTALArm 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.
DLI any time
EXPERIMENTALArm 2: DLI will be administered at any point after disease recurrence following HSCT.
DLI Pediatrics
EXPERIMENTALArm 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.
DLI - Haplo-Identical Family Donor
EXPERIMENTALArm 4: DLI administered as planned DLI or after recurrence in adult and pediatric patients undergoing transplant with a haplo-identical family donor.
Interventions
Hematopoietic stem-cell transplant using cells from a matched family donor (matched related allogeneic HSCT) using a non-T cell depleted graft under standard of care procedures
Allogeneic donor lymphocyte infusion (DLI) starting dose not to exceed 10\^6/m\^2 intravenously between 6 weeks and 12 weeks following allogeneic HSCT.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Ziopharm Oncologycollaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Kebriaei P, Singh H, Huls MH, Figliola MJ, Bassett R, Olivares S, Jena B, Dawson MJ, Kumaresan PR, Su S, Maiti S, Dai J, Moriarity B, Forget MA, Senyukov V, Orozco A, Liu T, McCarty J, Jackson RN, Moyes JS, Rondon G, Qazilbash M, Ciurea S, Alousi A, Nieto Y, Rezvani K, Marin D, Popat U, Hosing C, Shpall EJ, Kantarjian H, Keating M, Wierda W, Do KA, Largaespada DA, Lee DA, Hackett PB, Champlin RE, Cooper LJ. Phase I trials using Sleeping Beauty to generate CD19-specific CAR T cells. J Clin Invest. 2016 Sep 1;126(9):3363-76. doi: 10.1172/JCI86721. Epub 2016 Aug 2.
PMID: 27482888DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Partow Kebriaei, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2011
First Posted
December 22, 2011
Study Start
December 1, 2011
Primary Completion
March 8, 2021
Study Completion
March 8, 2021
Last Updated
March 13, 2025
Record last verified: 2025-03