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NCT00546897 · ClinicalTrials.gov registry record · Phase 2

Lenalidomide in Older Patients With Acute Myeloid Leukemia Without Chromosome 5q Abnormalities

A Phase 2 study, sponsored by Washington University School of Medicine.

Completed
Registry status
Phase 2
Development phase
48
Enrollment target

NCT00546897: Completed Phase 2 study, sponsored by Washington University School of Medicine.

NCT00546897 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 48 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00546897, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
Phase 2
Development phase
48 participants
Enrollment target

Study Summary

This study is designed to test the safety and efficacy of lenalidomide in older patients (age \> 60 years) with untreated acute myeloid leukemia without chromosomal abnormalities involving 5q.

Primary Outcome

CRm = Defined as morphologic leukemia-free state, including \<5% blasts in BM aspirate with marrow spicules and a count of \> 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC \> 1000/uL, platelet count \>100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. There is no duration requirement for this designation. CRi = Defined as CR with the exception of neutropenia \<1000/uL or thrombocytopenia \<

Interventions

  • DRUG Lenalidomide

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2007-02
Est. Completion 2012-03
Phase Phase 2

What the finished NCT00546897 record still lists

NCT00546897 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (64% lower).

The record links to 0 conditions, and to 1 intervention - of which Lenalidomide is the first listed.

NCT00546897 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00546897 about?

NCT00546897 is a clinical study titled "Lenalidomide in Older Patients With Acute Myeloid Leukemia Without Chromosome 5q Abnormalities". This study is designed to test the safety and efficacy of lenalidomide in older patients (age \> 60 years) with untreated acute myeloid leukemia without chromosomal abnormalities involving 5q.

What is the current status of trial NCT00546897?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2007-02. Estimated completion is 2012-03.

What interventions are being tested in trial NCT00546897?

The interventions under investigation include: Lenalidomide (DRUG).

Who is sponsoring clinical trial NCT00546897?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00546897's enrollment target sits among peer trials

48 1265th of 2000 higher than 718 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 NCT00546897, the US trial registry maintained by the National Library of Medicine. NCT00546897 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.