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COMPLETED Phase 2

NK Cell Based Non-Myeloablative Transplantation in Acute Myeloid Diseases

NCT01370213 · View on ClinicalTrials.gov ↗

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.

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01370213

The ClinicalTrials.gov registry entry for NCT01370213 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 154 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01370213 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Georgia, Minnesota, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01370213?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 154 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial