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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 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.

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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)

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

Sponsor

Celgene

308 total trials

What the Registry Record Tells You About NCT01178281

The ClinicalTrials.gov registry entry for NCT01178281 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 267 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 112-participant average among 30 other Primary Myelofibrosis trials with a reported enrollment target (138% higher). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.