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NCT01025154 · ClinicalTrials.gov registry record · Phase 2

Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
63
Enrollment target

NCT01025154: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT01025154 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 63 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01025154, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
63 participants
Enrollment target

Study Summary

The goal of this clinical research study is to learn if the combination of clofarabine, cytarabine, and idarubicin can help to control Acute Myeloid Leukemia (AML) in patients who are between the ages of 18 and 60 years old. The safety of this study drug combination will also be studied.

Primary Outcome

Overall Response (CR+CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L, and normal bone marrow differential (\< 5% blasts); and, Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of \< 100 x 10\^9/L. Response evaluated within 8 weeks after induction therapy.

Interventions

  • DRUG Cytarabine
  • DRUG Idarubicin
  • DRUG Clofarabine

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2010-01
Est. Completion 2013-02
Phase Phase 2
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01025154 record still lists

NCT01025154 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).

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

NCT01025154 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01025154 about?

NCT01025154 is a clinical study titled "Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction". The goal of this clinical research study is to learn if the combination of clofarabine, cytarabine, and idarubicin can help to control Acute Myeloid Leukemia (AML) in patients who are between the ages of 18 and 60 years old. The safety of this study drug combination will also be studied.

What is the current status of trial NCT01025154?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 63 participants. The study started on 2010-01. Estimated completion is 2013-02.

What interventions are being tested in trial NCT01025154?

The interventions under investigation include: Cytarabine (DRUG), Idarubicin (DRUG), Clofarabine (DRUG).

Who is sponsoring clinical trial NCT01025154?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01025154's enrollment target sits among peer trials

63 1009th of 2000 higher than 985 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 NCT01025154, the US trial registry maintained by the National Library of Medicine. NCT01025154 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.