Infusion of Allogeneic CD19-Specific T Cells From Peripheral Blood
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01497184
First received: December 20, 2011
Last updated: May 10, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Procedure: HSCT Genetic: DLI |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | CD19-Specific T Cell Infusion in Patients With B-Lineage Lymphoid Malignancies After Allogeneic Hematopoietic Stem Cell Transplantation |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Maximum Tolerated dose (MTD) of Donor Lymphocyte Infusion (DLI) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]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.
| Estimated Enrollment: | 96 |
| Study Start Date: | December 2011 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: DLI (Adults)
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.
|
Procedure: HSCT
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
Other Names:
Genetic: DLI
Allogeneic donor lymphocyte infusion (DLI) starting dose not to exceed 10^6/m^2 intravenously between 6 weeks and 12 weeks following allogeneic HSCT.
Other Names:
|
|
Experimental: DLI any time
Arm 2: DLI will be administered at any point after disease recurrence following HSCT.
|
Procedure: HSCT
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
Other Names:
Genetic: DLI
Allogeneic donor lymphocyte infusion (DLI) starting dose not to exceed 10^6/m^2 intravenously between 6 weeks and 12 weeks following allogeneic HSCT.
Other Names:
|
|
Experimental: DLI Pediatrics
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.
|
Procedure: HSCT
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
Other Names:
Genetic: DLI
Allogeneic donor lymphocyte infusion (DLI) starting dose not to exceed 10^6/m^2 intravenously between 6 weeks and 12 weeks following allogeneic HSCT.
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 1 Year to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with a history of B-cell lymphoid malignancies: 1) acute lymphoblastic leukemia (ALL),CD19+ or biphenotypic leukemia CD19+, or chronic lymphocytic leukemia in advanced remission, defined as beyond first complete remission, or with active disease, 2) non-Hodgkin's Lymphoma (NHL), which includes diffuse large B-cell lymphoma, small lymphocytic lymphoma, follicular lymphoma, or mantle cell lymphoma with active disease at time of transplant.
- 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.
- HLA-identical family donor or matched unrelated donor willing and able to donate additional hematopoietic progenitor cells in the event of graft failure.
- Patient is planned to receive 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.
- Absolute neutrophil count <500/uL at time of DLI.
- Less than 80% donor chimerism from peripheral blood within 30 days of DLI administration.
- 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 patients with history of CNS malignancy.
- Positive serology for HIV.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497184
Contacts
| Contact: Partow Kebriaei, MD | 713-745-0663 |
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Principal Investigator: | Partow Kebriaei, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01497184 History of Changes |
| Other Study ID Numbers: | 2009-0525 |
| Study First Received: | December 20, 2011 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Hematopoietic Stem Cell Transplantation Leukemia Lymphoma Allogeneic donor lymphocyte infusion DLI 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 |
Additional relevant MeSH terms:
|
Leukemia Lymphoma Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013