At a glance
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Phase I/II Study of Cellular Immunotherapy Using Central Memory-Enriched CD8+ T Cells Lentivirally Transduced to Express A CD19-Specific Chimeric Immunoreceptor Following Peripheral Blood Stem Cell Transplantation for Patients With High-Risk Intermediate Grade B-Lineage Non-Hodgkin Lymphoma
In Brief
A Phase 2 clinical trial evaluating Autologous Hematopoietic Stem Cell Transplantation, Filgrastim, and 5 other interventions for Recurrent Grade 1 Follicular Lymphoma and 4 related conditions. Active but no longer recruiting, targeting 8 participants across 1 site.
Detailed Summary
This phase I/II trial studies the side effects and best dose of genetically engineered lymphocyte therapy and to see how well it works after peripheral blood stem cell transplant (PBSCT) in treating patients with high-risk, intermediate-grade, B-cell non-Hodgkin lymphoma (NHL). Genetically engineered lymphocyte therapy may stimulate the immune system in different ways and stop cancer cells from growing. Giving rituximab together with chemotherapy before a PBSCT stops the growth of cancer cells by stopping them from dividing or killing them. Giving colony-stimulating factors, such as filgrastim (G-CSF), or plerixafor helps stem cells move from the bone marrow to the blood so they can be collected and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving genetically engineered lymphocyte therapy after PBSCT may be an effective treatment for NHL.
Study Details
Timeline
Interventions
Undergo autologous PBSCT
Given IV
Receive ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR
Correlative studies
Undergo autologous PBSCT
Given IV
Given IV