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NCT01607645 · ClinicalTrials.gov registry record · Phase 2

Decitabine Followed by Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory AML and MDS

A Phase 2 study, sponsored by Fred Hutchinson Cancer Center.

Terminated
Registry status
Phase 2
Development phase
7
Enrollment target

NCT01607645: Clinical Trial Phase 2 study, sponsored by Fred Hutchinson Cancer Center.

NCT01607645 is a Phase 2 study that was terminated before completion, run by Fred Hutchinson Cancer Center. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01607645, a Phase 2 study, was terminated before completion, sponsored by Fred Hutchinson Cancer Center.

TERMINATED
Registry status
Phase 2
Development phase
7 participants
Enrollment target

Study Summary

The goals of this study are to learn about the effectiveness, the side-effects, if waiting to give the idarubicin and cytarabine may change the side effects or effectiveness, and to identify factors to predict for responses to this therapy. The trial will examine combination of three chemotherapy drugs. These drugs are decitabine, idarubicin, and cytarabine.

Primary Outcome

Morphologic complete remission (CR): Absolute Neutrophil Count (ANC)≥1,000/uL, platelet count ≥100,000/uL, \<5% Bone Marrow (BM) blasts, no Auer rods (cytoplasmic inclusions which result from an abnormal fusion of the primary (azurophilic) granules), no morphologic dysplasia, and no evidence of extramedullary disease

Interventions

  • DRUG decitabine
  • DRUG cytarabine
  • DRUG idarubicin

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2012-07
Est. Completion 2013-09
Phase Phase 2
Fred Hutchinson Cancer Center

483 total trials

Why NCT01607645 stopped before completion

NCT01607645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 3 interventions - of which decitabine is the first listed.

NCT01607645 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01607645 about?

NCT01607645 is a clinical study titled "Decitabine Followed by Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory AML and MDS". The goals of this study are to learn about the effectiveness, the side-effects, if waiting to give the idarubicin and cytarabine may change the side effects or effectiveness, and to identify factors to predict for responses to this therapy. The trial will examine combination of three chemotherapy dr...

What is the current status of trial NCT01607645?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2012-07. Estimated completion is 2013-09.

What interventions are being tested in trial NCT01607645?

The interventions under investigation include: decitabine (DRUG), cytarabine (DRUG), idarubicin (DRUG).

Who is sponsoring clinical trial NCT01607645?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01607645's enrollment target sits among peer trials

7 1996th of 2000 higher than 5 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 NCT01607645, the US trial registry maintained by the National Library of Medicine. NCT01607645 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.