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NCT01464359 · ClinicalTrials.gov registry record · Phase 2

T-Cell Depleted Double UCB for Refractory AML

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

Terminated
Registry status
Phase 2
Development phase
3
Enrollment target

NCT01464359: Clinical Trial Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.

NCT01464359 is a Phase 2 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01464359, a Phase 2 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.

TERMINATED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

This trial is proposes to build on our experience and is designed to maximize early (day 3-14) and late (day 60-71) donor-derived natural killer (NK) cell expansion and function in vivo. The proposed platform will allow us the unique opportunity to compare in vivo function from a transplanted umbilical cord blood (UCB) source (presumed to contain NK progenitors requiring "education" in the recipient).

Primary Outcome

The primary endpoint is a disease free survival at 3 months in patients with chemotherapy refractory AML after a double T-cell depleted (TCD) umbilical cord blood (UCB) transplantation where one TCD unit is activated overnight in IL-2 followed by the administration of two courses of IL-2 three times a week for 6 doses beginning on day +3 and on day +60 to expand UCB-derived NK cells in vivo.

Interventions

  • DRUG Cyclophosphamide
  • DRUG Fludarabine
  • DRUG Levetiracetam
  • DRUG Allopurinol
  • RADIATION Total body irradiation

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2011-10
Est. Completion 2013-10
Phase Phase 2

Why NCT01464359 stopped before completion

NCT01464359 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

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

NCT01464359 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01464359 about?

NCT01464359 is a clinical study titled "T-Cell Depleted Double UCB for Refractory AML". This trial is proposes to build on our experience and is designed to maximize early (day 3-14) and late (day 60-71) donor-derived natural killer (NK) cell expansion and function in vivo. The proposed platform will allow us the unique opportunity to compare in vivo function from a transplanted umbili...

What is the current status of trial NCT01464359?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2011-10. Estimated completion is 2013-10.

What interventions are being tested in trial NCT01464359?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Levetiracetam (DRUG), Allopurinol (DRUG), Total body irradiation (RADIATION).

Who is sponsoring clinical trial NCT01464359?

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 NCT01464359's enrollment target sits among peer trials

3 2001st of 2000 the lowest 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 NCT01464359, the US trial registry maintained by the National Library of Medicine. NCT01464359 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.