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NCT02280525 · ClinicalTrials.gov registry record · Phase 1
Cord Blood Natural Killer (NK) Cells in Leukemia/Lymphoma
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT02280525: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT02280525 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02280525, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study 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.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
- DRUG Lenalidomide
- PROCEDURE NK Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-03-05 |
| Est. Completion | 2019-07-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02280525
The ClinicalTrials.gov registry entry for NCT02280525 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02280525 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02280525 about?
NCT02280525 is a clinical study titled "Cord Blood Natural Killer (NK) Cells in Leukemia/Lymphoma". 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 al...
What is the current status of trial NCT02280525?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2015-03-05. Estimated completion is 2019-07-09.
What interventions are being tested in trial NCT02280525?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), Lenalidomide (DRUG), NK Cells (PROCEDURE).
Who is sponsoring clinical trial NCT02280525?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
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