RECRUITING

A Phase 3 Study of Pacritinib in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis

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Conditions

Primary MyelofibrosisPost-polycythemia Vera MyelofibrosisPost-essential Thrombocythemia MyelofibrosismyelofibrosispacritinibRuxolitinibBone Marrow DiseaseHematologic DiseasesBlood Platelet DisordersHemorrhagic DisordersSplenomegalyAnemiaSpleen volumeSpleen

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study (study ID PAC203 North America; PAC303 ex-North America) is evaluating 200 mg BID of pacritinib compared to physician's choice (P/C) therapy in patients with MF and severe thrombocytopenia (platelet count \<50,000/μL). Approximately 399 patients in total will be enrolled, randomized 2:1 to either pacritinib (approximately 266 patients) or to P/C therapy (approximately 133 patients) Condition or disease: Primary Myelofibrosis/Post-Polycythemia Vera Myelofibrosis/ Post-essential Thrombocythemia Myelofibrosis Intervention/treatment: Drug-Pacritinib

Official Title

A Randomized, Controlled Phase 3 Study of Pacritinib Versus Physician's Choice in Patients With Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis With Severe Thrombocytopenia (Platelet Count <50,000/μL)(PACIFICA)

Quick Facts

Study Start:2017-06-26
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03165734

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Study Contact
CONTACT
+4686972000
medical.info@sobi.com

Principal Investigator

Simran Singh
STUDY_DIRECTOR
Sobi, Inc.

Study Locations (Sites)

University of Alabama at Birmingham, (UAB) Hospital, Comprehensive Cancer Center
Birmingham, Alabama, 35294
United States
Mayo Clinic Hospital
Phoenix, Arizona, 85054
United States
City of Hope
Duarte, California, 91010
United States
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
UCLA David Geffen School of Medicine
Los Angeles, California, 90095
United States
University of Colorado Cancer Center
Aurora, Colorado, 80045
United States
Rocky Mountain Cancer Centers (US Oncology/McKesson)
Boulder, Colorado, 80303
United States
Yale School of Medicine
New Haven, Connecticut, 06510
United States
Georgetown University Hospital
Washington, District of Columbia, 20007
United States
George Washington University-Medical Faculty Associates
Washington, District of Columbia, 20037
United States
Cleveland Clinic Florida
Weston, Florida, 33331
United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
The University of Chicago Medical Center
Chicago, Illinois, 60637
United States
University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, 66205
United States
Ochsner Medical Center
New Orleans, Louisiana, 70121
United States
Saint Agnes Hospital
Baltimore, Maryland, 21229
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817
United States
Regional Cancer Care Associates LLC - CCBD Division
Bethesda, Maryland, 20817
United States
Maryland Oncology Hematology, PA- Columbia
Columbia, Maryland, 21044
United States
Dana Farber Cancer Institute, Massachusetts General Hospital
Boston, Massachusetts, 02215
United States
Michigan Medicine Hematology Clinic-Rogel Cancer Center
Ann Arbor, Michigan, 48109
United States
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, 49546
United States
Washington University School of Medicine-Siteman Cancer Center
Saint Louis, Missouri, 63110
United States
Comprehensive Cancer Centers of Nevada- Twain Office
Las Vegas, Nevada, 89169
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Columbia University Medical Center
New York, New York, 10017
United States
Weill Cornell Medical College
New York, New York, 10021
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Memorial Sloan -Kettering Cancer Center
New York, New York, 10065
United States
University of Rochester
Rochester, New York, 14642
United States
Duke University Hospital
Durham, North Carolina, 27710
United States
Cleveland Clinic
Cleveland, Ohio, 44106
United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210
United States
Oregon Health and Science University
Portland, Oregon, 97239-3098
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
United States
The Sarah Cannon Research Institute-Tennessee Oncology
Nashville, Tennessee, 37203
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
Mays Cancer Center
San Antonio, Texas, 78229
United States
Texas Oncology- San Antonio
San Antonio, Texas, 78240
United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Swedish Orphan Biovitrum

  • Simran Singh, STUDY_DIRECTOR, Sobi, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-06-26
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2017-06-26
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

  • myelofibrosis
  • pacritinib
  • Post-polycythemia Vera Myelofibrosis
  • Post-essential Thrombocythemia Myelofibrosis
  • Ruxolitinib
  • Bone Marrow Disease
  • Hematologic Diseases
  • Blood Platelet Disorders
  • Hemorrhagic Disorders
  • Splenomegaly
  • Anemia
  • Spleen volume
  • Spleen

Additional Relevant MeSH Terms

  • Primary Myelofibrosis
  • Post-polycythemia Vera Myelofibrosis
  • Post-essential Thrombocythemia Myelofibrosis