Clinical Trials Directory

Trials / Completed

CompletedNCT00621452

Genetically Engineered Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Indolent B-Cell Non-Hodgkin Lymphoma

A Pilot Study to Evaluate the Safety and Feasibility of Cellular Immunotherapy Using Genetically Modified Autologous CD20-Specific T Cells For Patients With Relapsed or Refractory Mantle Cell and Indolent B Cell Lymphomas

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
12 (estimated)
Sponsor
Fred Hutchinson Cancer Center · Academic / Other
Sex
All
Age
—
Healthy volunteers
Not accepted

Summary

This phase I trial is studying the side effects of giving genetically engineered lymphocytes together with cyclophosphamide and aldesleukin in treating patients with relapsed or refractory mantle cell lymphoma or indolent B-cell non-Hodgkin lymphoma. Placing a gene that has been created in the laboratory into white blood cells may make the body build an immune response to kill cancer cells. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Aldesleukin may stimulate the white blood cells to kill lymphoma cells. Giving genetically engineered lymphocytes together with cyclophosphamide and aldesleukin may be an effective treatment for mantle cell lymphoma and B-cell non-Hodgkin lymphoma

Detailed description

PRIMARY OBJECTIVES: I. To assess the feasibility, safety and toxicity of cellular immunotherapy utilizing ex-vivo expanded autologous T cells genetically modified to express a "second generation' cluster of differentiation (CD)20-specific scFvFc:CD28:CD137:zeda chimeric immunoreceptor in patients with recurrent or refractory CD20+ mantle cell or indolent lymphoma. SECONDARY OBJECTIVES: I. To determine the duration of in vivo persistence of adoptively transferred CD20-specific T cells transfected with a CD20-specific scFvFc:CD28:CD137:zeda chimeric immunoreceptor. II. To assess the trafficking of CD20-specific T cells to lymphoma masses. III. To evaluate the development of host anti-CD20 scFvFc:CD28:CD137:zeda chimeric immunoreceptor and anti-neomycin-resistance gene (NeoR) immune responses in study subjects. OUTLINE: CHEMOTHERAPY: Patients receive cyclophosphamide IV over 60 minutes. IMMUNOTHERAPY: Beginning 2 days after completion of cyclophosphamide, patients receive autologous CD20-specific T-cells IV over 30 minutes. Treatment repeats every 2-5 days for 3 courses. MAINTENANCE THERAPY: Beginning 2 hours after the last T-cell infusion, patients receive low-dose aldesleukin subcutaneously twice daily for 14 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Subjects who have achieved at least a partial remission lasting a minimum of 6 months may, on a case-by-case basis, receive additional stored T cells following relapse. After completion of study treatment, patients are followed up weekly for one month, monthly for 1 year, and then annually for up to 2 years.

Conditions

Interventions

TypeNameDescription
BIOLOGICALtherapeutic autologous lymphocytesGiven IV
DRUGcyclophosphamideGiven IV
BIOLOGICALaldesleukinGiven subcutaneously
GENETICpolymerase chain reactionCorrelative studies
GENETICgene rearrangement analysisCorrelative studies
PROCEDURElymph node biopsyOptional correlative studies
BIOLOGICALgenetically engineered lymphocyte therapyReceive genetically modified T cells
PROCEDUREbone marrow aspirationOptional correlative studies
OTHERflow cytometryCorrelative studies
OTHERlaboratory biomarker analysisCorrelative studies
OTHERenzyme-linked immunosorbent assayCorrelative studies

Timeline

Start date
2007-08-01
Primary completion
2014-01-01
First posted
2008-02-22
Last updated
2014-08-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00621452. Inclusion in this directory is not an endorsement.