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NCT01178281 · ClinicalTrials.gov registry record · Phase 3

Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence

A Phase 3 study of Primary Myelofibrosis and MPN-associated Myelofibrosis, sponsored by Celgene.

Completed
Registry status
Phase 3
Development phase
267
Enrollment target
20
Study locations

NCT01178281: Completed Phase 3 study of Primary Myelofibrosis and MPN-associated Myelofibrosis, sponsored by Celgene.

NCT01178281 is a Phase 3 study of Primary Myelofibrosis and MPN-associated Myelofibrosis that has completed, run by Celgene. The registered enrollment target is 267 participants, above the 112-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (138% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01178281, a Phase 3 study of Primary Myelofibrosis and MPN-associated Myelofibrosis, has completed, sponsored by Celgene.

COMPLETED
Registry status
Phase 3
Development phase
267 participants
Enrollment target
20
Study locations

Study Summary

The objective of this study is to determine whether pomalidomide is safe and effective in reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis (global study) and in reversing anemia in Chinese with MPN-associated myelofibrosis and severe anemia not receiving RBC-transfusions (China extension study only)

Primary Outcome

RBC-transfusion independence was defined as the absence of RBC transfusions for any consecutive 84-day interval.

Interventions

  • DRUG Placebo
  • DRUG Pomalidomide
  • DRUG Pomalidomide 0.5 mg

Study Locations (20)

New York

  • Mount Sinai School of Medicine Brookdale University Hospital - Brooklyn
  • Weill Medical College of Cornell University - New York
  • Ruttenberg Treatment Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

Florida

  • University of Florida Shands Cancer Center - Gainesville
  • Mayo Clinic - Jacksonville

New South Wales

  • Gosford Hospital - Gosford
  • Royal North Shore Hospital - St Leonards

Arizona

  • Mayo Clinic - Scottsdale

California

  • UCLA School of Medicine - Los Angeles

Illinois

  • University of Illinois at Chicago - Chicago

Michigan

  • University of Michigan Comprehensive Cancer Center - Ann Arbor

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 267 participants
Start Date 2010-09-08
Est. Completion 2018-05-15
Phase Phase 3
Celgene

308 total trials

What the finished NCT01178281 record still lists

NCT01178281 is an interventional study that assigns participants to a tested intervention. The registered 267 participants enrollment target is mid-sized for trials with a published cap, above the 112-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (138% higher).

The record links to 2 conditions, with Primary Myelofibrosis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT01178281 names 20 study sites across 15 states, led by New York, Florida, New South Wales.

Frequently Asked Questions

What is clinical trial NCT01178281 about?

NCT01178281 is a clinical study titled "Study of Pomalidomide in Persons With Myeloproliferative-Neoplasm-Associated Myelofibrosis and RBC-Transfusion-Dependence". The objective of this study is to determine whether pomalidomide is safe and effective in reversing red blood cell (RBC)-transfusion-dependence in persons with myeloproliferative neoplasm (MPN)-associated myelofibrosis (global study) and in reversing anemia in Chinese with MPN-associated myelofibros...

What is the current status of trial NCT01178281?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 267 participants. The study started on 2010-09-08. Estimated completion is 2018-05-15.

What conditions does trial NCT01178281 study?

This clinical trial studies the following conditions: Primary Myelofibrosis, MPN-associated Myelofibrosis.

What interventions are being tested in trial NCT01178281?

The interventions under investigation include: Placebo (DRUG), Pomalidomide (DRUG), Pomalidomide 0.5 mg (DRUG).

Who is sponsoring clinical trial NCT01178281?

This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01178281 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Illinois, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Primary Myelofibrosis

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 NCT01178281's enrollment target sits among peer trials

267 6th of 30 higher than 25 of 30 other Primary Myelofibrosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Primary Myelofibrosis 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 NCT01178281, the US trial registry maintained by the National Library of Medicine. NCT01178281 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.