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A Phase I/II Study of Cellular Immunotherapy With Donor Central Memory-derived Virus-specific CD8+ T-cells Engineered to Target CD19 for CD19+ Malignancies After Allogeneic Hematopoietic Stem Cell Transplant
This phase I/II trial studies the safety and toxicity of post-transplant treatment with donor T cells engineered to express a chimeric antigen receptor (CAR) targeting CD19 in patients who have had a matched related allogeneic hematopoietic stem cell transplant for a CD19+ B cell malignancy.
Details
| Lead sponsor | Fred Hutchinson Cancer Center |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | COMPLETED |
| Enrolment | 1 |
| Start date | 2012-04 |
| Completion | 2014-07 |
Conditions
- Philadelphia Chromosome Negative Adult Precursor Acute Lymphoblastic Leukemia
- Philadelphia Chromosome Positive Adult Precursor Acute Lymphoblastic Leukemia
- Recurrent Adult Acute Lymphoblastic Leukemia
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Immunoblastic Large Cell Lymphoma
- Recurrent Mantle Cell Lymphoma
- Refractory Chronic Lymphocytic Leukemia
Interventions
- allogeneic cytomegalovirus-specific cytotoxic T lymphocytes
Primary outcomes
- Safety and toxicity assessment of study treatment — Up to day 42 after the T cell infusion
Incidence of grade \>= 3 toxicity, as defined by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 occurring from the T cell infusion through day 42 after the T cell infusion. Analysis will be performed separately in patients in complete remission (cohort A) or with detectable disease (cohort B) at day 28 post-transplant (prior to the T cell infusion). Incidence of acute GVHD occurring from the T cell infusion through day 42 after the T cell infusion will be assessed. - Feasibility assessment of study treatment — Up to 5 years
If the prescribed T cell dose is delivered in more than 50% of the patients, this approach will be considered feasible for further study to reduce relapse after allogeneic HCT.
Countries
United States