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| Sponsor: | Masonic Cancer Center, University of Minnesota |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00625729 |
Purpose
RATIONALE: Aldesleukin may stimulate natural killer cells to kill cancer cells. Treating natural killer cells with aldesleukin in the laboratory may help the natural killer cells kill more cancer cells when they are put back in the body. Giving monoclonal antibodies, such as rituximab, and chemotherapy drugs, such as fludarabine and cyclophosphamide, before a donor natural killer cell infusion helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells.
PURPOSE: This phase I/II trial is studying how well giving rituximab and chemotherapy followed by a donor natural killer cell infusion that has been treated in the laboratory with aldesleukin followed by aldesleukin works in treating patients with non-Hodgkin lymphoma or chronic lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Biological: aldesleukin Biological: lymphokine-activated killer cells Biological: rituximab Drug: cyclophosphamide Drug: fludarabine phosphate Other: laboratory biomarker analysis Other: pharmacogenomic studies Other: pharmacological study |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | MT2007-12 Allogeneic Natural Killer Cells With Rituximab in Patients With CD20 Positive Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia. Strategies to Increase Sensitivity of CLL Tumor Cells to Natural Killer Cell-Immune-Mediated Cytolysis |
| Estimated Enrollment: | 12 |
| Study Start Date: | January 2008 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE:
Patients who achieve a complete or partial response at 28 days are eligible for allogeneic stem cell transplantation. Patients who achieve initial response at 3 months, clinically benefit from treatment, but subsequently relapse are eligible for retreatment provided all eligibility criteria are met.
Blood samples are collected periodically for correlative laboratory studies. Patients with CLL also undergo bone marow aspiration periodically for correlative laboratory studies.
After completion of study treatment, patients are followed periodically for up to 1 year.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of CD20-positive non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL), meeting 1 of the following criteria:
Progression of NHL after at least 2 prior chemotherapy regimens*, defined by 1 of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, Minnesota | |
| Masonic Cancer Center at University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| Principal Investigator: | Veronika Bachanova, MD | Masonic Cancer Center, University of Minnesota |
More Information
| Responsible Party: | Masonic Cancer Center at University of Minnesota ( Veronika Bachanova ) |
| Study ID Numbers: | CDR0000586667, UMN-2007LS064, MT2007-12, UMN-0707M13561 |
| Study First Received: | February 26, 2008 |
| Last Updated: | December 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00625729 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent adult grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma Waldenstrom macroglobulinemia recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma |
recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma refractory chronic lymphocytic leukemia |
|
Antimetabolites Anti-Infective Agents Leukemia, Lymphoid Vidarabine Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Leukemia Anti-Retroviral Agents Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Alkylating Agents |
Lymphoma Anti-HIV Agents Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases Rituximab Fludarabine monophosphate Antiviral Agents Immunosuppressive Agents Pharmacologic Actions Lymphatic Diseases Neoplasms Aldesleukin Myeloablative Agonists Fludarabine |