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NCT01149408 · ClinicalTrials.gov registry record · Phase 1

Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients

A Phase 1 study of Acute Myeloid Leukemia and AML, sponsored by University of Utah.

Completed
Registry status
Phase 1
Development phase
3
Enrollment target
1
Study location

NCT01149408: Completed Phase 1 study of Acute Myeloid Leukemia and AML, sponsored by University of Utah.

NCT01149408 is a Phase 1 study of Acute Myeloid Leukemia and AML that has completed, run by University of Utah. The registered enrollment target is 3 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01149408, a Phase 1 study of Acute Myeloid Leukemia and AML, has completed, sponsored by University of Utah.

COMPLETED
Registry status
Phase 1
Development phase
3 participants
Enrollment target
1
Study location

Study Summary

The study aims at determining the feasibility of using maintenance Decitabine therapy following remission induction and consolidation in elderly Acute Myeloid Leukemia patients who are fit for aggressive therapy. Primary: Safety and tolerability of the decitabine regimen in the post remission state. Secondary: 1. Disease-free survival - To determine the one-year disease-free survival in elderly patients with acute myeloid leukemia (AML) in complete remission treated with Decitabine as post-consolidation maintenance therapy. 2. Overall survival

Primary Outcome

Patient will come to the infusion center for a one-hour infusion on three (3) consecutive days during a 28-day cycle. The 28-day cycle will be repeated for up to 18 months if tolerated or there is no evidence of loss of remission. Patient will receive maintenance therapy with the study drug Decitabine. The Long-Term Follow-Up Schedule begins from the end of treatment. All patients who receive at least one dose of study drug will be followed for a minimum of one year. The maximum follow-up for a

Conditions Studied

Acute Myeloid Leukemia AML

Interventions

  • DRUG Decitabine (Dacogen)

Study Locations (1)

Utah

  • University of Utah, Huntsman Cancer Institute - Salt Lake City

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2011-02
Est. Completion 2014-09
Phase Phase 1
University of Utah

818 total trials

What the finished NCT01149408 record still lists

NCT01149408 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 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (97% lower).

The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Decitabine (Dacogen) is the first listed.

NCT01149408 reports a single indexed study location in Utah.

Frequently Asked Questions

What is clinical trial NCT01149408 about?

NCT01149408 is a clinical study titled "Decitabine Maintenance in Elderly Acute Myeloid Leukemia Patients". The study aims at determining the feasibility of using maintenance Decitabine therapy following remission induction and consolidation in elderly Acute Myeloid Leukemia patients who are fit for aggressive therapy. Primary: Safety and tolerability of the decitabine regimen in the post remission state...

What is the current status of trial NCT01149408?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2011-02. Estimated completion is 2014-09.

What conditions does trial NCT01149408 study?

This clinical trial studies the following conditions: Acute Myeloid Leukemia, AML.

What interventions are being tested in trial NCT01149408?

The interventions under investigation include: Decitabine (Dacogen) (DRUG).

Who is sponsoring clinical trial NCT01149408?

This trial is sponsored by University of Utah, which has 818 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01149408 being conducted?

This trial has 1 study location across Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Acute Myeloid Leukemia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01149408's enrollment target sits among peer trials

3 307th of 306 the lowest of 306 other Acute Myeloid Leukemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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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Related registry views

Source: ClinicalTrials.gov NCT01149408, the US trial registry maintained by the National Library of Medicine. NCT01149408 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.