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NCT01178814 · ClinicalTrials.gov registry record · Phase 2

Revlimid in Transfusion Dependent Patients

A Phase 2 study, sponsored by Columbia University.

Completed
Registry status
Phase 2
Development phase
57
Enrollment target

NCT01178814: Completed Phase 2 study, sponsored by Columbia University.

NCT01178814 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 57 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01178814, a Phase 2 study, has completed, sponsored by Columbia University.

COMPLETED
Registry status
Phase 2
Development phase
57 participants
Enrollment target

Study Summary

This is a prospective trial of Revlimid for subjects who have a blood cell cancer called myelodysplastic syndrome (MDS). Cells in their marrow make proteins through messages that are carried from the genes. The amount of the message tells researchers if the protein it is going to make is high or low. This is known as expression of genes. The purpose of this study is to conduct a prospective trial testing the idea that expression of specific genes can help to predict which patients will respond to study drug administration with Revlimid (lenalidomide).

Primary Outcome

The trial will be testing the Revlimid® (lenalidomide) response signature in patients who have transfusion dependent, non-del(5q), low and intermediate-1 risk myelodysplastic syndromes (MDS) in order to confirm the predictive value of the signature and to establish the boundaries of the z-score which can be used to pre-select patients in future clinical studies. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR),

Interventions

  • DRUG Revlimid (Lenalidomide)

Trial Details

FieldValue
Enrollment Target 57 participants
Start Date 2009-06-01
Est. Completion 2022-12-07
Phase Phase 2
Columbia University

958 total trials

What the finished NCT01178814 record still lists

NCT01178814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).

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

NCT01178814 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01178814 about?

NCT01178814 is a clinical study titled "Revlimid in Transfusion Dependent Patients". This is a prospective trial of Revlimid for subjects who have a blood cell cancer called myelodysplastic syndrome (MDS). Cells in their marrow make proteins through messages that are carried from the genes. The amount of the message tells researchers if the protein it is going to make is high or low...

What is the current status of trial NCT01178814?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2009-06-01. Estimated completion is 2022-12-07.

What interventions are being tested in trial NCT01178814?

The interventions under investigation include: Revlimid (Lenalidomide) (DRUG).

Who is sponsoring clinical trial NCT01178814?

This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01178814's enrollment target sits among peer trials

57 1141st of 2000 higher than 855 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 NCT01178814, the US trial registry maintained by the National Library of Medicine. NCT01178814 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.