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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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). 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.
Primary Outcome
Primary objective is to determine maximum tolerated dose (MTD). Dose-limiting toxicity (DLT) target rate is at most 20%. DLT includes any grade 4 toxicity related to NK infusion related toxicity; grades 3-5 allergic reactions related to study cell infusion; grades 3-5 organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) not pre-existing or due to underlying malignancy or due to preparative chemotherapy and occurring within 30 days post-
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 |
What the finished NCT02280525 record still lists
NCT02280525 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02280525 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02280525's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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