Genetically Engineered Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Indolent B-Cell Non-Hodgkin Lymphoma
NCT ID: NCT00621452
Last Updated: 2014-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2007-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (autologous CD20 specific T-cells)
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.
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.
therapeutic autologous lymphocytes
Given IV
cyclophosphamide
Given IV
aldesleukin
Given subcutaneously
polymerase chain reaction
Correlative studies
gene rearrangement analysis
Correlative studies
lymph node biopsy
Optional correlative studies
genetically engineered lymphocyte therapy
Receive genetically modified T cells
bone marrow aspiration
Optional correlative studies
flow cytometry
Correlative studies
laboratory biomarker analysis
Correlative studies
enzyme-linked immunosorbent assay
Correlative studies
Interventions
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therapeutic autologous lymphocytes
Given IV
cyclophosphamide
Given IV
aldesleukin
Given subcutaneously
polymerase chain reaction
Correlative studies
gene rearrangement analysis
Correlative studies
lymph node biopsy
Optional correlative studies
genetically engineered lymphocyte therapy
Receive genetically modified T cells
bone marrow aspiration
Optional correlative studies
flow cytometry
Correlative studies
laboratory biomarker analysis
Correlative studies
enzyme-linked immunosorbent assay
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Willingness to sign an informed consent and undergo study tests
* Willingness to receive cytoreductive chemotherapy, if necessary to debulk tumors prior to T cell administration, and to receive cyclophosphamide for lymphodepletion
* Serologic evidence of prior exposure to Epstein-Barr virus (EBV)
* Meets safety criteria to undergo leukapheresis
* Hemoglobin \> 9.0 gm/dL
* White blood cell (WBC) \> 2500 per microliter
* Alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase \[SGPT\]) =\< 2.5 x Upper Limit of Normal
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 x Upper Limit of Normal
* Creatinine =\< 1.6 mg/dL
* Willingness to use acceptable (barrier or hormonal methods) birth control as appropriate during the course of the study
Exclusion Criteria
* Known central nervous system involvement with NHL
* Pulmonary involvement with NHL; a diagnosis of pulmonary lymphoma will be based in part on findings from chest computed tomography (CT) and, if clinically appropriate, lung biopsy
* Exposure to chemotherapeutic agents (standard or experimental) or other immunosuppressive therapies less than four weeks prior to apheresis; patients must have recovered from acute side effects of such therapy
* Positive serology for human immunodeficiency virus (HIV)
* Active Hepatitis B or Hepatitis C infection
* History of hypersensitivity reactions to murine proteins or seropositivity for human anti-mouse antibody (HAMA)
* Requirement for corticosteroid therapy during the study period unless used specifically for amelioration of toxicity induced by transferred cells
* Treatment with anti-CD20 antibodies (rituximab, tositumomab, ibritumomab) within 4 months prior to start of T cell infusions
* Patients with lymph nodes in excess of 5 cm in diameter at time of T cell infusion
* Patients with \> 5000 circulating CD20+ lymphocytes per mm\^3 at time of T cell infusion
* Previous allogeneic stem cell transplantation
* Life expectancy less than 90 days
* Pregnancy
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Brian Till
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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References
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Till BG, Jensen MC, Wang J, Qian X, Gopal AK, Maloney DG, Lindgren CG, Lin Y, Pagel JM, Budde LE, Raubitschek A, Forman SJ, Greenberg PD, Riddell SR, Press OW. CD20-specific adoptive immunotherapy for lymphoma using a chimeric antigen receptor with both CD28 and 4-1BB domains: pilot clinical trial results. Blood. 2012 Apr 26;119(17):3940-50. doi: 10.1182/blood-2011-10-387969. Epub 2012 Feb 3.
Other Identifiers
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NCI-2010-00416
Identifier Type: REGISTRY
Identifier Source: secondary_id
2154.00
Identifier Type: -
Identifier Source: org_study_id
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