drugset / Trial / NCT02280525

Cord Blood Natural Killer (NK) Cells in Leukemia/Lymphoma

NCT02280525

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of immune cells called natural killer (NK) cells that can be given with chemotherapy to patients with CLL. Researchers want to learn if adding NK cells will be effective in treating the disease. The safety of this will also be studied. NK cells may kill cancer cells that remain in your body after your last chemotherapy treatment. The NK cells will be separated from umbilical cord blood. The device used in the laboratory to separate the NK cells is called a CliniMACS. These separated NK cells will then be grown in the lab to increase the number of NK cells that can be given to you by vein. This is an investigational study. Rituximab, fludarabine, and cyclophosphamide are FDA approved and commercially available for the treatment of CLL. Cytarabine, filgrastim, and lenalidomide are FDA approved and commercially available for the treatment of other types of cancer. The use of cytarabine, filgrastim, and lenalidomide for the treatment of CLL is investigational. The use of NK cells is investigational. The NK cell process is not FDA approved or commercially available. It is currently being used for research purposes only. Up to 44 patients will take part in this study. All will be enrolled at MD Anderson.

Timeline

Start
2015-03-05
Primary completion
2019-07-09
Completion
2019-07-09

Drugs

EvaluationDrugModalityDoseRoute
Background Cyclophosphamide Other / unclassified 60 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 200 mg/m2 Intravenous
Background Cytarabine Small molecule 2 mg/m2 Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background Lenalidomide Other / unclassified 2.5 mg Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous

Indications