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NCT01823198 · ClinicalTrials.gov registry record · Phase 1
Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT01823198: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01823198 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 63 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01823198, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of donor natural killer cells when given together with donor stem cell transplant and to see how well they work in treating patients with myeloid malignancies that are likely to come back or spread. Giving chemotherapy, such as busulfan and fludarabine phosphate, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets.
Primary Outcome
Participants that experienced DLT related to the NK Cells post transplant at different dose levels.
Interventions
- DRUG Busulfan
- DRUG Fludarabine Phosphate
- PROCEDURE Allogeneic Hematopoietic Stem Cell Transplantation
- BIOLOGICAL Aldesleukin
- BIOLOGICAL Allogeneic CD56-positive CD3-negative Natural Killer Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-06-11 |
| Est. Completion | 2022-05-10 |
| Phase | Phase 1 |
What the finished NCT01823198 record still lists
NCT01823198 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Busulfan is the first listed.
NCT01823198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01823198 about?
NCT01823198 is a clinical study titled "Donor Natural Killer Cells and Donor Stem Cell Transplant in Treating Patients With High Risk Myeloid Malignancies". This phase I/II trial studies the side effects and best dose of donor natural killer cells when given together with donor stem cell transplant and to see how well they work in treating patients with myeloid malignancies that are likely to come back or spread. Giving chemotherapy, such as busulfan an...
What is the current status of trial NCT01823198?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2013-06-11. Estimated completion is 2022-05-10.
What interventions are being tested in trial NCT01823198?
The interventions under investigation include: Busulfan (DRUG), Fludarabine Phosphate (DRUG), Allogeneic Hematopoietic Stem Cell Transplantation (PROCEDURE), Aldesleukin (BIOLOGICAL), Allogeneic CD56-positive CD3-negative Natural Killer Cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01823198?
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 NCT01823198's enrollment target sits among peer trials
63 820th of 2000 higher than 1,177 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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