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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00176475 |
RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may help the patient's immune system kill cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving irradiated donor lymphocytes together with rituximab may kill more cancer cells.
PURPOSE: This clinical trial is studying the side effects and how well giving irradiated donor lymphocytes together with rituximab works in treating patients with relapsed or refractory lymphoproliferative disease.
Condition | Intervention |
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Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm |
Drug: rituximab Drug: therapeutic allogeneic lymphocytes Procedure: fluorescence in situ hybridization Procedure: polymorphism analysis Procedure: reverse transcriptase-polymerase chain reaction |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes in Conjunction With Rituximab for Selected Patients With CD20 + Malignancies |
Estimated Enrollment: | 20 |
Study Start Date: | February 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot study.
Peripheral blood is collected periodically during study for correlative laboratory studies. Blood samples are analyzed for FcγIIIA polymorphism by fluorescent in situ hybridization or by reverse transcriptase-polymerase chain reaction. Survival of donor lymphocytes is assessed by chimerism studies.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed lymphoproliferative disease
Resistant or refractory to standard therapies and/or unlikely to benefit from additional standard therapies* AND meets 1 of the following criteria:
Disease with anticipated response rate < 20% after treatment with rituximab alone, including any of the following:
Relapsed or progressive disease after prior treatment with rituximab, including any of the following:
Chronic lymphocytic leukemia/small lymphocytic lymphoma meeting any of the following criteria:
B-cell prolymphocytic leukemia meeting any of the following criteria:
Lymphoplasmacytic lymphoma, marginal zone lymphoma, mucosa-associated lymphoid tissue lymphoma, or follicular lymphoma meeting any of the following criteria:
Multiple myeloma meeting any of the following criteria:
Mantle cell lymphoma meeting the following criteria:
Diffuse large B-cell lymphoma meeting any of the following criteria:
Burkitt's lymphoma meeting any of the following criteria:
Lymphomatoid granulomatosis meeting any of the following criteria:
Acute lymphocytic leukemia meeting any of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New Jersey | |
Cancer Institute of New Jersey at Hamilton | Recruiting |
Hamilton, New Jersey, United States, 08690 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey at Ham 609-631-6946 | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 |
Principal Investigator: | Roger Strair, MD, PhD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000540171, CINJ-5035, CINJ-010406-5035 |
Study First Received: | September 12, 2005 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00176475 |
Health Authority: | Unspecified |
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult Hodgkin lymphoma recurrent adult lymphoblastic lymphoma recurrent adult acute lymphoblastic leukemia refractory chronic lymphocytic leukemia recurrent small lymphocytic lymphoma refractory hairy cell leukemia prolymphocytic leukemia recurrent marginal zone lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
refractory multiple myeloma recurrent mantle cell lymphoma recurrent adult grade III lymphomatoid granulomatosis Waldenstrom macroglobulinemia splenic marginal zone lymphoma stage II multiple myeloma stage III multiple myeloma stage IV adult Burkitt lymphoma stage IV adult diffuse large cell lymphoma stage IV adult Hodgkin lymphoma stage IV adult lymphoblastic lymphoma stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult Hodgkin lymphoma stage III adult lymphoblastic lymphoma |
Leukemia, Lymphoid Hodgkin's disease Blood Protein Disorders Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, Follicular Paraproteinemias Lymphoma, B-Cell, Marginal Zone Hemostatic Disorders Acute lymphoblastic leukemia, adult Lymphoma, large-cell Lymphoma, B-Cell Lymphomatoid granulomatosis Burkitt's lymphoma Leukemia |
Hemorrhagic Disorders Leukemia, Prolymphocytic Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Prolymphocytic leukemia Waldenstrom macroglobulinemia Hodgkin Disease Lymphoma Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Lymphomatoid Granulomatosis Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Rituximab Hematologic Diseases |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Cardiovascular Diseases Antirheumatic Agents Pharmacologic Actions |