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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 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.

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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.

Conditions Studied

Acute Myeloid Leukemia Myelodysplastic Syndrome

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

FieldValue
Enrollment Target 25 participants
Start Date 2011-09
Est. Completion 2017-04
Phase Phase 2

Sponsor

Masonic Cancer Center, University of Minnesota

249 total trials

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What the Registry Record Tells You About NCT01370213

The ClinicalTrials.gov registry entry for NCT01370213 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (78% lower). The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.

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