drugset / Trial / NCT01318317

Genetically Engineered Lymphocyte Therapy After Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk, Intermediate-Grade, B-cell Non-Hodgkin Lymphoma

NCT01318317

Phase 1/2 Active not recruiting 8 enrolled City of Hope Medical Center National Cancer Institute (NCI) · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-09-19
Primary completion
2013-10-03
Completion
2027-02-24

Drugs

EvaluationDrugModalityDoseRoute
Subject CD19 CAR-T cells Cell therapy
Background Plerixafor Small molecule Intravenous
Background Rituximab Monoclonal antibody Intravenous
Background filgrastim Protein / enzyme biologic Intravenous

Indications