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NCT01370213 · ClinicalTrials.gov registry record · Phase 2
NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 4
- Study locations
NCT01370213: Completed Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by Masonic Cancer Center, University of Minnesota.
NCT01370213 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 25 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (78% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01370213, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 4
- Study locations
Study Summary
This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative haploidentical transplantation for the treatment of high-risk acute myeloid diseases. Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early stopping rule is met. If 9 or more of these first 15 patients achieve leukemia free neutrophil engraftment at day +28 accrual will move to stage 2. In stage 2, an additional 28 patients will be enrolled for a total of 43 patients. Patients will be followed for disease response for 2 years.
Primary Outcome
The rate of donor neutrophil engraftment in the absence of leukemia at day +28 will be determined. Successful neutrophil engraftment is defined as an absolute donor-derived neutrophil count of \>500 cells/μl. Leukemia free is defined as \<5% bone marrow blasts, absence of blasts with Auer rods; absence of extramedullary disease; but cytogenetic or molecular minimal residual disease is allowed.
Conditions Studied
Interventions
- DRUG Interleukin-2
- BIOLOGICAL NK Cells
- DRUG Preparative Regimen
- BIOLOGICAL CD34 Graft/Anti-thymocyte globulin
- BIOLOGICAL Donor TCR α/β-depleted Graft/ATG
Study Locations (4)
Georgia
- Emory University - Atlanta
Minnesota
- University of Minnesota, Masonic Cancer Center - Minneapolis
Missouri
- Washington University - St Louis
Ohio
- Ohio State University - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2011-09 |
| Est. Completion | 2017-04 |
| Phase | Phase 2 |
What the finished NCT01370213 record still lists
NCT01370213 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Interleukin-2 is the first listed.
NCT01370213 reports a single indexed study location in Georgia, Minnesota, Missouri.
Frequently Asked Questions
What is clinical trial NCT01370213 about?
NCT01370213 is a clinical study titled "NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases". This is a phase II multi-institutional therapeutic study of NK-cell based nonmyeloablative haploidentical transplantation for the treatment of high-risk acute myeloid diseases. Enrollment will use a two-stage design. Stage 1 will enroll 15 patients unless an early stopping rule is met. If 9 or more ...
What is the current status of trial NCT01370213?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2011-09. Estimated completion is 2017-04.
What conditions does trial NCT01370213 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome.
What interventions are being tested in trial NCT01370213?
The interventions under investigation include: Interleukin-2 (DRUG), NK Cells (BIOLOGICAL), Preparative Regimen (DRUG), CD34 Graft/Anti-thymocyte globulin (BIOLOGICAL), Donor TCR α/β-depleted Graft/ATG (BIOLOGICAL).
Who is sponsoring clinical trial NCT01370213?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01370213 being conducted?
This trial has 4 study locations across Georgia, Minnesota, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01370213's enrollment target sits among peer trials
25 220th of 306 higher than 83 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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.
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