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ACTIVE NOT RECRUITING
NCT01318317
PHASE1/PHASE2

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

Sponsor: City of Hope Medical Center

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2011-09-19

Completion Date

2026-02-26

Last Updated

2025-04-25

Healthy Volunteers

No

Interventions

PROCEDURE

Autologous Hematopoietic Stem Cell Transplantation

Undergo autologous PBSCT

BIOLOGICAL

Filgrastim

Given IV

BIOLOGICAL

Genetically Engineered Lymphocyte Therapy

Receive ex vivo expanded autologous TCM-enriched CD8+ T cells expressing CD19-specific CAR

OTHER

Laboratory Biomarker Analysis

Correlative studies

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo autologous PBSCT

DRUG

Plerixafor

Given IV

BIOLOGICAL

Rituximab

Given IV

Locations (1)

City of Hope Medical Center

Duarte, California, United States