Back to resultsPacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia (PAC326)
Primary Purpose
Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pacritinib
Best Available Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Primary Myelofibrosis focused on measuring Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Primary Myelofibrosis, Polycythemia Vera, Essential Thrombocythemia, Bone Marrow Disease, Hematologic Diseases, Hemorrhagic Disorders, Splenomegaly, Pacritinib, MPN-SAF, MPN-SAF TSS, Anemia, Myeloproliferative Neoplasm, Spleen volume, Thrombocytopenia, SB1518
Eligibility Criteria
Inclusion Criteria:
- Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)
- Thrombocytopenia (platelet count ≤ 100,000/µL) at any time after signing informed consent
- Palpable splenomegaly ≥ 5 cm on physical examination
- Total Symptom Score ≥ 13 on the MPN-SAF TSS 2.0, not including the inactivity question
- Patients who are platelet or red blood cell transfusion-dependent are eligible
- Adequate white blood cell counts (with low blast counts), liver function, and renal function
- At least 6 months from prior splenic irradiation
- At least 1-4 weeks since prior myelofibrosis therapy, including any erythropoietic or thrombopoietic agent
- Not pregnant, not lactating, and agree to use effective birth control
- Able and willing to undergo frequent MRI or CT assessments and complete symptom assessments using a patient-reported outcome instrument
Exclusion Criteria:
- Prior treatment with more than 2 JAK2 inhibitors or with pacritinib
- There is no maximum cumulative prior JAK2 inhibitor treatment
- History of (or plans to undergo) spleen removal surgery or allogeneic stem cell transplant
- Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel disease, chronic diarrhea, or constipation
- Active bleeding that requires hospitalization during the screening period
- Cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or other QTc risk factors, myocardial infarction
- Other malignancy within last 3 years other than certain limited skin, cervical, prostate, breast, or bladder cancers
- Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A, B, or C), psychiatric disorder, or social situation that would prevent good care on this study
- Life expectancy < 6 months
Sites / Locations
- Mayo Clinic Arizona
- Arizona Clinical Research Center
- City of Hope
- Moores Cancer Centre
- USC Norris Comprehensive Cancer Center
- Stanford Cancer Center
- Rocky Mountain Cancer Center
- George Washington University- Medical Faculty Associates
- SCRI- Florida Cancer Specialists South Region
- SCRI - Florida Cancer Specialists North Region
- H. Lee Moffitt Cancer Center & Research Institute
- Northwestern University
- Carle Cancer Center
- Indiana University Goshen Cancer Centre
- Investigative Clinical Research of Indiana
- University of Iowa Hospitals and Clinics
- Siouxland Hematology-Oncology Associates, L.L.P (SHOA)
- Norton Cancer Institute, Suburban
- St Joseph Mercy Hospital
- University of Michigan
- Henry Ford Health System
- Providence Cancer Institute
- Washington University School of Medicine Division of Oncology
- Nebraska Hematology-Oncology, P.C.
- Hackensack University
- Hematology-Oncology Associates of Northern Jersey
- New Mexico Cancer Care Alliance
- Mount Sinai Medical Center
- Columbia University Medical Center
- Stony Brook University Medical Center
- SCRI-Oncology Hematology Care
- Cleveland Clinic-Taussig Cancer Center
- University of Oklahoma
- Thomas Jefferson University
- UPMC Hillman Cancer Center
- Upstate Oncology Associates
- Sarah Cannon Research Institute (SCRI)
- Texas Onocolgy-Baylor Sammons Cancer Center
- UT Southwestern Medical Center
- UTMB Galveston
- Houston Methodist
- University of Texas MD Anderson Cancer Center
- Cancer Care Centers of South Texas
- Huntsman Cancer Hospital
- Virginia Cancer Specialists
- Providence Regional Cancer Partnership
- Fred Hutchinson Cancer Research Center
- Green Bay Oncology
- Froedtert Hospital and the Medical College of Wisconsin
- Medical College of Wisconsin
- St George Hospital
- Royal Adelaide Hospital
- Box Hill Hospital
- Monash Health - Monash Medical Centre
- Perth Blood Institute
- Haematology and Oncology Clinics of Australia
- Prince of Wales Hospital
- Centre Hospitalier de Jolimont-Lobbes
- ZNA - Stuivenberg
- AZ Sint Jan Brugge-Oostende AV
- Hopital Brugmann
- Cliniques Universitaires St-Luc
- St Augustinus
- UC Louvain
- Saint John Regional Hospital
- Princess Margaret Cancer Center
- Fakultní nemocnice Brno
- Faculty Hospital Olomouc
- Fakultní nemocnice Plzeň
- University Hospital Hradec Kralove
- Chu d'Amiens Hopital Sud
- Hôpital Caremeau
- CHU Rennes
- CHU Purpan
- CH de Mulhouse
- CHU de CAEN
- Centre Hospitalier de Lens
- Hopital l'Archet, CHU de Nice
- Saint Antoine Hospital
- Centre Hospitalier Lyon Sud
- CHU de Strasbourg
- Institut Gustave Roussy
- Charite-Medical University
- Gemeinschaftspraxis Hämatologie/Onkologie
- University Hospital Essen
- Uniklinik Freiburg
- Universitatsklinikum Halle (Saale)
- Klinik I fur Innere Medizin, Universitat Koln
- University Hospital Leipzig
- Städtisches Klinikum München GmbH
- University of Munster
- University Hospital Ulm
- Semmelweis Egyetem AOK
- University of Debrecen, Belgyogyaszati Intezet
- Bekes Megyei Pandy Kalman Korhaz
- Kaposi Mór Oktató Kórház
- SZTE II. sz Belgyogyoszati Klinika es Kardiologiai Kozpont
- Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőint
- University Hospital Maastricht
- Erasmus MC
- Auckland District Health Board, Auckland City Hospital
- Middlemore Hospital
- Canterbury District Health Board
- North Shore Hospital
- CCDHB - Wellington Hospital
- Bashkir State Medical University
- Saratov State Medical University
- National Haematology Research Center
- Republican Hopsital n.a. V.A. Baranov
- Ryazan Regional Clinical Hospital
- Russian Research Institute of Hematology and Transfusiology
- Military Medical Academy n.a. S.M. Kirov
- Royal Liverpool University Hospital
- Belfast Health and Social Care Trust
- Birmingham Heartlands Hospital
- Beatson West of Scotland Cancer Centre
- Leicester Royal Infirmary
- Guy's Hospital
- Hammersmith Hosp - ICH NHS Trust
- The Christie NHS Foundation Trust
- Oxford University Hospitals NHS Trust
- Royal Hallamshire Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Pacritinib, Once Daily
Pacritinib, Twice Daily
Best Available Therapy
Arm Description
Pacritinib 400 mg QD
Pacritinib 200 mg BID
BAT includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry.
Outcomes
Primary Outcome Measures
Spleen Volume Reduction
Proportion of patients achieving a ≥ 35% reduction in spleen volume from baseline to week 24 as measured by magnetic resonance imaging (MRI) or computed tomography (CT).
Total Symptom Score (TSS) Reduction
Proportion of patients achieving a ≥ 50% reduction in the total symptom score from baseline to Week 24 on the Myeloproliferative Neoplasm Symptom Assessment Form 2.0 (MPN-SAF TSS 2.0). Responses (on a scale from 0 [absent] to 10 [worst imaginable]) to questions about symptoms (tiredness, early satiety, abdominal discomfort, night sweats, pruritus, bone pain, and pain under the ribs on the left side) were used to calculate the TSS.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02055781
Brief Title
Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia
Acronym
PAC326
Official Title
A Randomized Controlled Phase 3 Study of Oral Pacritinib Versus Best Available Therapy in Patients With Thrombocytopenia and Primary Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, or Post-Essential Thrombocythemia Myelofibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Study Start Date
February 2014 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CTI BioPharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib compared to Best Available Therapy (BAT) in patients with thrombocytopenia and primary or secondary myelofibrosis.
Detailed Description
Multicenter, randomized, controlled, phase 3 trial comparing the safety and efficacy of pacritinib with that of BAT in patients with thrombocytopenia and primary or secondary myelofibrosis. Approximately 300 eligible patients will be randomized in a 1:1:1 allocation to pacritinib 400 mg dosed QD, pacritinib 200 mg dosed BID, or BAT (includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry). Spleen volume will be measured by MRI or CT at baseline and every 12 weeks thereafter. An independent radiology facility (IRF), blind to treatment assignments, will measure spleen volumes. Patients will also be followed for safety, Leukemia Free Survival (LFS), Overall Survival (OS), frequency of red blood cell (RBC) and platelet transfusions, and other exploratory endpoints. An Independent Data Monitoring Committee (IDMC) will evaluate the safety of pacritinib.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Myelofibrosis, Post-polycythemia Vera Myelofibrosis, Post-essential Thrombocythemia Myelofibrosis
Keywords
Myelofibrosis, Post-Polycythemia Vera Myelofibrosis, Post-Essential Thrombocythemia Myelofibrosis, Primary Myelofibrosis, Polycythemia Vera, Essential Thrombocythemia, Bone Marrow Disease, Hematologic Diseases, Hemorrhagic Disorders, Splenomegaly, Pacritinib, MPN-SAF, MPN-SAF TSS, Anemia, Myeloproliferative Neoplasm, Spleen volume, Thrombocytopenia, SB1518
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
311 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pacritinib, Once Daily
Arm Type
Experimental
Arm Description
Pacritinib 400 mg QD
Arm Title
Pacritinib, Twice Daily
Arm Type
Experimental
Arm Description
Pacritinib 200 mg BID
Arm Title
Best Available Therapy
Arm Type
Active Comparator
Arm Description
BAT includes any physician-selected treatment for myelofibrosis, such as approved JAK2 inhibitors administered according to package insert for patients with thrombocytopenia, and may include any treatment received before study entry.
Intervention Type
Drug
Intervention Name(s)
Pacritinib
Intervention Type
Drug
Intervention Name(s)
Best Available Therapy
Primary Outcome Measure Information:
Title
Spleen Volume Reduction
Description
Proportion of patients achieving a ≥ 35% reduction in spleen volume from baseline to week 24 as measured by magnetic resonance imaging (MRI) or computed tomography (CT).
Time Frame
Baseline to Week 24
Title
Total Symptom Score (TSS) Reduction
Description
Proportion of patients achieving a ≥ 50% reduction in the total symptom score from baseline to Week 24 on the Myeloproliferative Neoplasm Symptom Assessment Form 2.0 (MPN-SAF TSS 2.0). Responses (on a scale from 0 [absent] to 10 [worst imaginable]) to questions about symptoms (tiredness, early satiety, abdominal discomfort, night sweats, pruritus, bone pain, and pain under the ribs on the left side) were used to calculate the TSS.
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)
Thrombocytopenia (platelet count ≤ 100,000/µL) at any time after signing informed consent
Palpable splenomegaly ≥ 5 cm on physical examination
Total Symptom Score ≥ 13 on the MPN-SAF TSS 2.0, not including the inactivity question
Patients who are platelet or red blood cell transfusion-dependent are eligible
Adequate white blood cell counts (with low blast counts), liver function, and renal function
At least 6 months from prior splenic irradiation
At least 1-4 weeks since prior myelofibrosis therapy, including any erythropoietic or thrombopoietic agent
Not pregnant, not lactating, and agree to use effective birth control
Able and willing to undergo frequent MRI or CT assessments and complete symptom assessments using a patient-reported outcome instrument
Exclusion Criteria:
Prior treatment with more than 2 JAK2 inhibitors or with pacritinib
There is no maximum cumulative prior JAK2 inhibitor treatment
History of (or plans to undergo) spleen removal surgery or allogeneic stem cell transplant
Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel disease, chronic diarrhea, or constipation
Active bleeding that requires hospitalization during the screening period
Cardiovascular disease, including recent history or currently clinically symptomatic and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or other QTc risk factors, myocardial infarction
Other malignancy within last 3 years other than certain limited skin, cervical, prostate, breast, or bladder cancers
Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A, B, or C), psychiatric disorder, or social situation that would prevent good care on this study
Life expectancy < 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simran Singh
Organizational Affiliation
Sr. Director, Head of Clinical Operations
Official's Role
Study Director
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Moores Cancer Centre
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80303
Country
United States
Facility Name
George Washington University- Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
SCRI- Florida Cancer Specialists South Region
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
SCRI - Florida Cancer Specialists North Region
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Indiana University Goshen Cancer Centre
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46526
Country
United States
Facility Name
Investigative Clinical Research of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates, L.L.P (SHOA)
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Norton Cancer Institute, Suburban
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
St Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Providence Cancer Institute
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
Washington University School of Medicine Division of Oncology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nebraska Hematology-Oncology, P.C.
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Hackensack University
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Hematology-Oncology Associates of Northern Jersey
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
New Mexico Cancer Care Alliance
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SCRI-Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Cleveland Clinic-Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Upstate Oncology Associates
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Sarah Cannon Research Institute (SCRI)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Onocolgy-Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UTMB Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Cancer Care Centers of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Huntsman Cancer Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Virginia Cancer Specialists
City
Leesburg
State/Province
Virginia
ZIP/Postal Code
20176
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Green Bay Oncology
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Froedtert Hospital and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
St George Hospital
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Box Hill Hospital
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Monash Health - Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Perth Blood Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Haematology and Oncology Clinics of Australia
City
Chermside
ZIP/Postal Code
4032
Country
Australia
Facility Name
Prince of Wales Hospital
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Facility Name
Centre Hospitalier de Jolimont-Lobbes
City
Haine-Saint-Paul
State/Province
Hainaut
Country
Belgium
Facility Name
ZNA - Stuivenberg
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
AZ Sint Jan Brugge-Oostende AV
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Hopital Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
St Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
UC Louvain
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
Fakultní nemocnice Brno
City
Brno
State/Province
NAP
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Faculty Hospital Olomouc
City
Olomouc
State/Province
NAP
ZIP/Postal Code
775 20
Country
Czechia
Facility Name
Fakultní nemocnice Plzeň
City
Plzeň
State/Province
NAP
ZIP/Postal Code
30460
Country
Czechia
Facility Name
University Hospital Hradec Kralove
City
Králová
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Chu d'Amiens Hopital Sud
City
Amiens
State/Province
Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
Hôpital Caremeau
City
Nimes
State/Province
Cedex 9
ZIP/Postal Code
30029
Country
France
Facility Name
CHU Rennes
City
Rennes
State/Province
Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
CHU Purpan
City
Toulouse
State/Province
Cedex 9
ZIP/Postal Code
31059
Country
France
Facility Name
CH de Mulhouse
City
Mulhouse
State/Province
Cedex
ZIP/Postal Code
68070
Country
France
Facility Name
CHU de CAEN
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Centre Hospitalier de Lens
City
Lens
ZIP/Postal Code
62300
Country
France
Facility Name
Hopital l'Archet, CHU de Nice
City
Nice
ZIP/Postal Code
BP 30 79 06202
Country
France
Facility Name
Saint Antoine Hospital
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif Cedex
ZIP/Postal Code
94805
Country
France
Facility Name
Charite-Medical University
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Gemeinschaftspraxis Hämatologie/Onkologie
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
University Hospital Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Uniklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitatsklinikum Halle (Saale)
City
Halle (Saale)
ZIP/Postal Code
06120
Country
Germany
Facility Name
Klinik I fur Innere Medizin, Universitat Koln
City
Koln
ZIP/Postal Code
50924
Country
Germany
Facility Name
University Hospital Leipzig
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Städtisches Klinikum München GmbH
City
Munchen
ZIP/Postal Code
81737
Country
Germany
Facility Name
University of Munster
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
University Hospital Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Semmelweis Egyetem AOK
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
University of Debrecen, Belgyogyaszati Intezet
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bekes Megyei Pandy Kalman Korhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Kaposi Mór Oktató Kórház
City
Kaposvár
ZIP/Postal Code
7400
Country
Hungary
Facility Name
SZTE II. sz Belgyogyoszati Klinika es Kardiologiai Kozpont
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőint
City
Szolnok
ZIP/Postal Code
5004
Country
Hungary
Facility Name
University Hospital Maastricht
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Auckland District Health Board, Auckland City Hospital
City
Auckland
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Middlemore Hospital
City
Auckland
ZIP/Postal Code
1640
Country
New Zealand
Facility Name
Canterbury District Health Board
City
Christchurch
ZIP/Postal Code
8001
Country
New Zealand
Facility Name
North Shore Hospital
City
Takapuna
ZIP/Postal Code
0740
Country
New Zealand
Facility Name
CCDHB - Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Bashkir State Medical University
City
Ufa
State/Province
Republic Of Bashkortostan
ZIP/Postal Code
450083
Country
Russian Federation
Facility Name
Saratov State Medical University
City
Saratov
State/Province
Saratov Region
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
National Haematology Research Center
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Republican Hopsital n.a. V.A. Baranov
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Ryazan Regional Clinical Hospital
City
Ryazan
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Russian Research Institute of Hematology and Transfusiology
City
St. Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Military Medical Academy n.a. S.M. Kirov
City
St. Petersburg
ZIP/Postal Code
194044
Country
Russian Federation
Facility Name
Royal Liverpool University Hospital
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Belfast Health and Social Care Trust
City
Belfast
State/Province
N. Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 OYN
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Hammersmith Hosp - ICH NHS Trust
City
London
ZIP/Postal Code
W12 OHS
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
29522138
Citation
Mascarenhas J, Hoffman R, Talpaz M, Gerds AT, Stein B, Gupta V, Szoke A, Drummond M, Pristupa A, Granston T, Daly R, Al-Fayoumi S, Callahan JA, Singer JW, Gotlib J, Jamieson C, Harrison C, Mesa R, Verstovsek S. Pacritinib vs Best Available Therapy, Including Ruxolitinib, in Patients With Myelofibrosis: A Randomized Clinical Trial. JAMA Oncol. 2018 May 1;4(5):652-659. doi: 10.1001/jamaoncol.2017.5818.
Results Reference
background
PubMed Identifier
34551507
Citation
Verstovsek S, Mesa R, Talpaz M, Kiladjian JJ, Harrison CN, Oh ST, Vannucchi AM, Rampal R, Scott BL, Buckley SA, Craig AR, Roman-Torres K, Mascarenhas JO. Retrospective analysis of pacritinib in patients with myelofibrosis and severe thrombocytopenia. Haematologica. 2022 Jul 1;107(7):1599-1607. doi: 10.3324/haematol.2021.279415.
Results Reference
derived
PubMed Identifier
33275766
Citation
Tremblay D, Mesa R, Scott B, Buckley S, Roman-Torres K, Verstovsek S, Mascarenhas J. Pacritinib demonstrates spleen volume reduction in patients with myelofibrosis independent of JAK2V617F allele burden. Blood Adv. 2020 Dec 8;4(23):5929-5935. doi: 10.1182/bloodadvances.2020002970.
Results Reference
derived
Learn more about this trial
Pacritinib Versus Best Available Therapy to Treat Patients With Myelofibrosis and Thrombocytopenia
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