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NCT01106950 · ClinicalTrials.gov registry record · Phase 2

Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML)

A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.

Terminated
Registry status
Phase 2
Development phase
15
Enrollment target

NCT01106950: Clinical Trial Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.

NCT01106950 is a Phase 2 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 15 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01106950, a Phase 2 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.

TERMINATED
Registry status
Phase 2
Development phase
15 participants
Enrollment target

Study Summary

This is a phase II therapeutic study of related donor HLA-haploidentical NK-cell based therapy after a high dose of fludarabine/cyclophosphamide with denileukin diftitox preparative regimen for the treatment of poor prognosis acute myelogenous leukemia (AML).

Primary Outcome

The primary objective of this study was to estimate the incidence of in vivo expansion of natural killer (NK) cells 14 days after infusion of an allogeneic donor product enriched for NK progenitors. Successful in vivo donor NK cell expansion was defined by measuring an absolute circulating donor-derived NK cell count of \>100 cells/ul in the patient's peripheral blood 14 days after infusion.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • BIOLOGICAL Natural Killer Cells
  • DRUG Denileukin diftitox
  • PROCEDURE Donor lymphapheresis

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2010-07
Est. Completion 2012-12
Phase Phase 2

Why NCT01106950 stopped before completion

NCT01106950 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).

The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.

NCT01106950 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01106950 about?

NCT01106950 is a clinical study titled "Haploidentical Natural Killer Cells to Treat Refractory or Relapsed Acute Myelogenous Leukemia (AML)". This is a phase II therapeutic study of related donor HLA-haploidentical NK-cell based therapy after a high dose of fludarabine/cyclophosphamide with denileukin diftitox preparative regimen for the treatment of poor prognosis acute myelogenous leukemia (AML).

What is the current status of trial NCT01106950?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 15 participants. The study started on 2010-07. Estimated completion is 2012-12.

What interventions are being tested in trial NCT01106950?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Natural Killer Cells (BIOLOGICAL), Denileukin diftitox (DRUG), Donor lymphapheresis (PROCEDURE).

Who is sponsoring clinical trial NCT01106950?

This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01106950's enrollment target sits among peer trials

15 1919th of 2000 higher than 60 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01106950, the US trial registry maintained by the National Library of Medicine. NCT01106950 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.