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NCT01656252 · ClinicalTrials.gov registry record · Phase 1

Trial of Eltrombopag During Consolidation Therapy in Adults With AML in Complete Remission

A Phase 1 study, sponsored by PrECOG.

Terminated
Registry status
Phase 1
Development phase
15
Enrollment target

NCT01656252: Clinical Trial Phase 1 study, sponsored by PrECOG.

NCT01656252 is a Phase 1 study that was terminated before completion, run by PrECOG. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01656252, a Phase 1 study, was terminated before completion, sponsored by PrECOG.

TERMINATED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

Patients with Acute Myeloid Leukemia (AML) in complete remission will receive eltrombopag while undergoing consolidation chemotherapy with high-dose cytarabine. Eltrombopag may help increase the number of platelets during chemotherapy and may help prevent the risk of bleeding. Phase I will study the side effects, best dose and platelet effects of eltrombopag when given with consolidation chemotherapy. After the maximum safe and tolerated dose and schedule is found in Phase I, the study will proceed to Phase II. Phase II will confirm the dose and schedule of eltrombopag identified in Phase I that can increase platelet counts in patients receiving consolidation therapy.

Primary Outcome

To determine the safety, tolerability and optimal dose of eltrombopag in acute myeloid leukemia patients in complete remission receiving intensive consolidation chemotherapy. The optimal dose was based on rules involving observation of Dose Limiting Toxicity (DLT events), defined as a CTCAE Version 4 non-hematologic adverse event of grade 3 or higher occurring within 30 days of the last dose of eltrombopag judged by the investigator to be at least possibly related to eltrombopag administration.

Interventions

  • DRUG Phase I- Cytarabine & Eltrombopag
  • DRUG Phase II- Sequence A
  • DRUG Phase II- Sequence B

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2012-07
Est. Completion 2016-03
Phase Phase 1
PrECOG

17 total trials

Why NCT01656252 stopped before completion

NCT01656252 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 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).

The record links to 0 conditions, and to 3 interventions - of which Phase I- Cytarabine & Eltrombopag is the first listed.

NCT01656252 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01656252 about?

NCT01656252 is a clinical study titled "Trial of Eltrombopag During Consolidation Therapy in Adults With AML in Complete Remission". Patients with Acute Myeloid Leukemia (AML) in complete remission will receive eltrombopag while undergoing consolidation chemotherapy with high-dose cytarabine. Eltrombopag may help increase the number of platelets during chemotherapy and may help prevent the risk of bleeding. Phase I will study th...

What is the current status of trial NCT01656252?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2012-07. Estimated completion is 2016-03.

What interventions are being tested in trial NCT01656252?

The interventions under investigation include: Phase I- Cytarabine & Eltrombopag (DRUG), Phase II- Sequence A (DRUG), Phase II- Sequence B (DRUG).

Who is sponsoring clinical trial NCT01656252?

This trial is sponsored by PrECOG, which has 17 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01656252's enrollment target sits among peer trials

15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT01656252, the US trial registry maintained by the National Library of Medicine. NCT01656252 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.