Donor Natural Killer Cell Infusion, Rituximab, Aldesleukin, and Chemotherapy in Treating Patients With Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia
Summary
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.
Timeline
- Start
- 2008-01
- Primary completion
- 2009-12
- Completion
- 2010-04
Outcome
Outcome not reported
Stopped: “No patients exhibited natural killer cell expansion (primary endpoint).”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Allogeneic natural killer cells | Cell therapy | 1.5e+07 cells/kg | Intravenous |
| Subject | Allogeneic natural killer cells | Cell therapy | 8e+07 cells/kg | Intravenous |
| Subject | aldesleukin | Protein / enzyme biologic | 1e+07 iu | Subcutaneous |
| Background | Cyclophosphamide | Other / unclassified | 60 mg/kg | Intravenous |
| Background | Fludarabine | Small molecule | 25 mg/m2 | Intravenous |
| Background | Rituximab | Monoclonal antibody | 357 mg/m2 | Intravenous |