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Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00621452 |
RATIONALE: Biological therapies, such as adoptive cellular immunotherapy, may stimulate the immune system in different ways and stop cancer cells from growing.
PURPOSE: This phase I trial is studying the side effects and best way to give adoptive cellular immunotherapy with gene-modified T cells in treating patients with relapsed or refractory mantle cell lymphoma or indolent B-cell non-Hodgkin lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: aldesleukin Drug: fludarabine phosphate Drug: therapeutic autologous lymphocytes Procedure: biopsy Procedure: gene rearrangement analysis Procedure: polymerase chain reaction Procedure: western blotting |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | 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 |
Estimated Enrollment: | 12 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
Patients with a large tumor burden or actively growing lymphoma undergo cytoreductive chemotherapy (by referring community oncologist) to reduce the tumor burden, after leukapheresis and before lymphodepleting therapy.
Treatment continues in the absence of progressive disease or unacceptable toxicity.
Patients with pathologic lymphadenopathy undergo excisional lymph node biopsy of a superficial lymph node or core needle biopsy 24-48 hours following the second or third T-cell infusion. All patients undergo bone marrow biopsy and aspiration 24-48 hours following the final T-cell infusion. Samples are analyzed for DNA isolation and PCR evaluation to identify the chimeric gene sequence. Blood samples are collected 18-24 hours after each T cell infusion, for direct assay of peripheral blood lymphocytes for vector DNA by PCR and expression of chimeric T cell receptor by western blot.
After completion of study treatment, patients are followed weekly for 1 month and then periodically for up to 2 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Immunohistopathologically confirmed CD20+ mantle cell lymphoma or indolent B-cell non-Hodgkin lymphoma (NHL), including 1 of the following types:
Willing to receive cytoreductive chemotherapy, if necessary, to debulk tumors to achieve the following criteria before T cell infusion:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent treatment with any of the following agents:
United States, Washington | |
Fred Hutchinson Cancer Research Center | Recruiting |
Seattle, Washington, United States, 98109-1024 | |
Contact: Brian Till, MD 206-667-7269 tillb@fhcrc.org | |
Seattle Cancer Care Alliance | Recruiting |
Seattle, Washington, United States, 98109-1023 | |
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 |
Principal Investigator: | Brian Till, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000586447, FHCRC-2154.00, FHCRC-IR 6547 |
Study First Received: | February 21, 2008 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00621452 |
Health Authority: | Unspecified |
recurrent marginal zone lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent mantle cell lymphoma |
Waldenstrom macroglobulinemia splenic marginal zone lymphoma nodal marginal zone B-cell lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue |
Immunoproliferative Disorders Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoma, B-Cell, Marginal Zone Fludarabine monophosphate Mantle cell lymphoma Recurrence Lymphoma, B-Cell Lymphatic Diseases |
Waldenstrom Macroglobulinemia Aldesleukin B-cell lymphomas Waldenstrom macroglobulinemia Fludarabine Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma |
Antimetabolites Anti-Infective Agents Neoplasms by Histologic Type Antimetabolites, Antineoplastic Anti-HIV Agents Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action |
Antineoplastic Agents Physiological Effects of Drugs Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Neoplasms Anti-Retroviral Agents Therapeutic Uses |