drugset / Trial / NCT00625729

Donor Natural Killer Cell Infusion, Rituximab, Aldesleukin, and Chemotherapy in Treating Patients With Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia

NCT00625729

NaSingle-groupOpen-labelTreatment

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

Drugs

EvaluationDrugModalityDoseRoute
Subject TROCULEUCEL Cell therapy 1.5e+07 cells/kg Intravenous
Subject TROCULEUCEL 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

Indications