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

NCT01318317 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-05-05

Study results available
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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.

Conditions

  • Recurrent Grade 1 Follicular Lymphoma
  • Recurrent Grade 2 Follicular Lymphoma
  • Recurrent Grade 3 Follicular Lymphoma
  • Recurrent Mantle Cell Lymphoma
  • Recurrent Non-Hodgkin Lymphoma

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Elizabeth L Budde, MD,PhD · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01318317 on ClinicalTrials.gov