Phase
Condition
Anemia
Post-essential Thrombocythemia Myelofibrosis
Thrombosis
Treatment
ruxolitinib
INCB000928
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Participants with MF who are transfusion-dependent or present with symptomaticanemia, defined as follows:
Anemia: An Hgb value < 10 g/dL demonstrated during screening recorded on 3separate occasions with at least 7 days between measurements (Note: RBCtransfusion must be at least 2 weeks before the Hgb measurement duringscreening).
Transfusion-dependent: Participant has received at least 4 units of RBCtransfusions during the 28 days immediately preceding Cycle 1 Day 1 OR hasreceived an average of at least 4 units of RBC transfusions in the 8 weeksimmediately preceding Cycle 1 Day 1, for an Hgb level of < 8.5 g/dL, in theabsence of bleeding or treatment-induced anemia. In addition, the most recenttransfusion episode must have occurred in the 28 days before Cycle 1 Day 1.
- ECOG performance status score of the following:
0 or 1 for the dose-escalation stages.
0, 1, or 2 for the dose-expansion stage.
Life expectancy is greater than 6 months
Agreement to avoid pregnancy or fathering children.
Ineligible to receive or have not responded to available therapies for anemia suchas ESAs.
For TGA:
Participants previously treated with JAK inhibitors for at least 12 weeks.
Participants with intermediate-2 or high DIPSS MF according to IWG-MRT criteria.
For TGB:
Participants must have been on a therapeutic and stable regimen of ruxolitinib forat least 12 consecutive weeks immediately preceding the first dose of studytreatment.
Participants with intermediate-1, intermediate-2, or high DIPSS MF according toIWG-MRT criteria.
For TGC:
Participants must be JAK inhibitor treatment naive (no prior treatment with any JAKinhibitor) and have an indication for initiation of ruxolitinib treatment.
Participants with intermediate-1, intermediate-2, or high DIPSS MF according toIWG-MRT criteria.
Exclusion
Exclusion Criteria:
Undergone any prior allogenic or autologous stem cell transplantation or a candidatefor such transplantation.
Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy,biological therapy, endocrine therapy, targeted therapy, antibody or hypomethylatingagent to treat the participant's disease, with the exception of ruxolitinib for TGBonly, within 5 half-lives or 28 days (whichever is shorter) before the first dose ofstudy treatment.
Laboratory Values outside of protocol defined range at screening.
Study Design
Connect with a study center
Princess Margaret Cancer Center
Toronto, Ontario M5G 2M9
CanadaSite Not Available
McGill University Jewish General Hospital
Montreal, Quebec H3T1E2
CanadaSite Not Available
St Paul'S Hospital
Vancouver, V6Z2A5
CanadaSite Not Available
Centre Hospitalier D'Angers
Angers Cedex 01, 49033
FranceSite Not Available
Institut Paoli-Calmettes
Marseille, 13009
FranceSite Not Available
Institut Paoli Calmettes
Marseille Cedex 9, 13273
FranceSite Not Available
Institut Paoli-Calmettes
Marseille Cedex 9, 13273
FranceActive - Recruiting
Hospital Saint Louis
Paris, 75010
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94800
FranceSite Not Available
Azienda Ospedaliera Papa Giovanni Xxiii
Bergamo, 24127
ItalySite Not Available
S Orsolas University Hospital Seragnoli Institute of Hematology
Bologna, 40138
ItalySite Not Available
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Firenze, 50134
ItalySite Not Available
Azienda Ospedaliera Universitaria San Luigi Gonzaga Orbassano
Orbassano, 10043
ItalySite Not Available
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo
Pavia, 27100
ItalySite Not Available
Ospedale Santa Maria Della Misericordia Perugia
Perugia, 06124
ItalySite Not Available
Tokyo Medical and Dental University Hospital
Bunkyo-ku, 113-8519
JapanSite Not Available
Chiba Cancer Center
Chiba, 260-8717
JapanSite Not Available
Gifu Municipal Hospital
Gifu, 500-8513
JapanSite Not Available
Kansai Medical University Hospital
Hirakata, 573-1191
JapanSite Not Available
Kumamoto Shinto General Hospital
Kumamoto, 862-8655
JapanSite Not Available
Osaka International Cancer Institute
Osaka, 541-8567
JapanSite Not Available
Osaka International Cancer Institute
Osaka-shi, 541-8567
JapanSite Not Available
University Hospital of Wales
Cardiff, WLS CF14 4XW
United KingdomSite Not Available
United Lincolnshire Hospitals
Boston, PE21 9QS
United KingdomSite Not Available
Lincoln County Hospital
Lincoln, LN2 5QY
United KingdomSite Not Available
Churchill Hospital
Oxford, OX3 7LE
United KingdomSite Not Available
Royal Cornwall Hospital Truro Sunrise Centre
Truro, TR1 3LJ
United KingdomSite Not Available
Genesiscare Center
Windsor, SL4 3HD
United KingdomSite Not Available
City of Hope National Medical Center
Duarte, California 91010
United StatesSite Not Available
City of Hope Orange County
Irvine, California 92618
United StatesSite Not Available
Usc Norris Comprehensive Cancer Center
Los Angeles, California 90089
United StatesSite Not Available
Stanford Cancer Center
Palo Alto, California 94304
United StatesSite Not Available
Prebys Cancer Center
San Diego, California 92103
United StatesSite Not Available
Emory University - Winship Cancer Institute
Atlanta, Georgia 30322
United StatesSite Not Available
Emory University-Winship Cancer Institute
Atlanta, Georgia 30322
United StatesSite Not Available
Loyola University Medical Center
Maywood, Illinois 60153
United StatesSite Not Available
Start Midwest
Grand Rapids, Michigan 49546
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Weill Cornell Medical Centers
New York, New York 10065
United StatesSite Not Available
Duke University Medical Center, Department of Hematologic Malignancies and Cellular Therapy
Durham, North Carolina 27705
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Md Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
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