Genetically Engineered Lymphocytes, Cyclophosphamide, and Aldesleukin in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or Indolent B-Cell Non-Hodgkin Lymphoma
NCT00621452 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2014-08-06
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
Conditions
- B-cell Chronic Lymphocytic Leukemia
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Nodal Marginal Zone B-cell Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Marginal Zone Lymphoma
- Recurrent Small Lymphocytic Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Splenic Marginal Zone Lymphoma
- Waldenström Macroglobulinemia
Interventions
- BIOLOGICAL
-
therapeutic autologous lymphocytes
Given IV
- DRUG
-
Given IV
- BIOLOGICAL
-
aldesleukin
Given subcutaneously
- GENETIC
-
polymerase chain reaction
Correlative studies
- GENETIC
-
gene rearrangement analysis
Correlative studies
- PROCEDURE
-
lymph node biopsy
Optional correlative studies
- BIOLOGICAL
-
genetically engineered lymphocyte therapy
Receive genetically modified T cells
- PROCEDURE
-
bone marrow aspiration
Optional correlative studies
- OTHER
-
flow cytometry
Correlative studies
- OTHER
-
laboratory biomarker analysis
Correlative studies
- OTHER
-
enzyme-linked immunosorbent assay
Correlative studies
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Fred Hutchinson Cancer Center
lead OTHER
Principal Investigators
-
Brian Till · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-08-31
- Primary Completion
- 2014-01-31
Countries
- United States
Study Locations
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