Cord Blood Natural Killer (NK) Cells in Leukemia/Lymphoma
Status:
Unknown status
Trial end date:
2021-03-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Celgene Corporation The Leukemia and Lymphoma Society