Phase
Condition
Myelofibrosis
White Cell Disorders
Post-polycythemia Vera Myelofibrosis
Treatment
Ruxolitinib
INCA033989
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Life expectancy > 6 months.
Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
Participants with MF and ET as defined in the protocol.
Exclusion
Exclusion Criteria:
Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
Active invasive malignancy over the previous 2 years.
Active HBV/HCV, HIV.
History of clinically significant or uncontrolled cardiac disease.
Has undergone any prior allogenic or autologous stem-cell transplantation or suchtransplantation is planned.
Laboratory values outside the Protocol-defined ranges.
Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any timewithin 4 weeks before the first dose of study treatment.
Prior history of major bleeding, or thrombosis within the last 3 months prior tostudy enrollment.
Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy,biological therapy, endocrine therapy, targeted therapy, antibody, orhypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
For TGBs only: Undergoing treatment with a potent/strong inhibitor or inducer of CYP 3A4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose ofstudy treatment, or expected to receive such treatment during the study.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study Design
Connect with a study center
Royal Brisbane and Women'S Hospital
Herston, Queensland 04029
AustraliaActive - Recruiting
Royal Brisbane and Women'S Hospital
Herston 6931014, Queensland 2152274 04029
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia 05000
AustraliaActive - Recruiting
Royal Adelaide Hospital
Adelaide 2078025, South Australia 2061327 05000
AustraliaSite Not Available
Peter Maccallum Cancer Centre
Melbourne, Victoria 03000
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 03004
AustraliaActive - Recruiting
Peter Maccallum Cancer Centre
North Melbourne, Victoria 03051
AustraliaSite Not Available
Peter Maccallum Cancer Centre
Melbourne 2158177, Victoria 2145234 03000
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne 2158177, Victoria 2145234 03004
AustraliaSite Not Available
Princess Margaret Cancer Center
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Princess Margaret Cancer Center
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaSite Not Available
Hopital Maisonneuve-Rosemont, Montreal, Qc
Montreal, Quebec H1T 2M4
CanadaActive - Recruiting
Hopital Maisonneuve-Rosemont, Montreal, Qc
Montreal 6077243, Quebec 6115047 H1T 2M4
CanadaSite Not Available
Odense University Hospital
Odense C, 05000
DenmarkSite Not Available
Odense University Hospital
Odense C 11746507, 05000
DenmarkSite Not Available
Sjaellands Universitetshospital
Roskilde, 04000
DenmarkActive - Recruiting
Sjaellands Universitetshospital
Roskilde 2614481, 04000
DenmarkSite Not Available
Vejle Hospital
Vejle, 07100
DenmarkActive - Recruiting
Vejle Hospital
Vejle 2610613, 07100
DenmarkSite Not Available
Institut Bergonie
Bordeaux, 33076
FranceActive - Recruiting
Institut Bergonie
Bordeaux 3031582, 33076
FranceSite Not Available
Chu Nimes
Nimes, 30029
FranceSite Not Available
Chu Nimes
Nîmes, 30029
FranceActive - Recruiting
Chu Nimes
Nîmes 2990363, 30029
FranceSite Not Available
Hospital Saint Louis
Paris, 75010
FranceActive - Recruiting
Hospital Saint Louis
Paris 2988507, 75010
FranceSite Not Available
Institut Gustave Roussy
Villejuif, 94805
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif 2968705, 94805
FranceSite Not Available
Institut Gustave Roussy
Villejuif Cedex, 94805
FranceSite Not Available
University Medical Center Rwth Aachen
Aachen, 52074
GermanyActive - Recruiting
University Medical Center Rwth Aachen
Aachen 3247449, 52074
GermanySite Not Available
Universitatsklinikum Halle (Saale)
Halle, 06120
GermanyActive - Recruiting
Universitatsklinikum Halle (Saale)
Halle 2911522, 06120
GermanySite Not Available
Universitatsklinikum Ulm
ULM, 89081
GermanySite Not Available
Universitätsklinikum Ulm
Ulm, 89081
GermanyActive - Recruiting
Universitätsklinikum Ulm
Ulm 2820256, 89081
GermanySite Not Available
Aou Policlinico S. Orsola-Malpighi
Bologna, 40138
ItalyActive - Recruiting
Aou Policlinico S. Orsola-Malpighi Bologna
Bologna, 40138
ItalyActive - Recruiting
Aou Policlinico S. Orsola-Malpighi Bologna&Nbsp;
Bologna, 40138
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi
Bologna, 40138
ItalyActive - Recruiting
L Azienda Ospedaliero-Universitaria Di Bologna Policlinico S. Orsola - Malpighi
Bologna, 40138
ItalySite Not Available
Aou Policlinico S. Orsola-Malpighi
Bologna 3181928, 40138
ItalySite Not Available
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Firenze, 50134
ItalySite Not Available
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence, 50134
ItalyActive - Recruiting
Azienda Ospedaliero-Universitaria Careggi (Aouc)
Florence 3176959, 50134
ItalySite Not Available
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan, 20122
ItalyActive - Recruiting
Fondazione Irccs Ca Granda Ospedale Maggiore
Milan 3173435, 20122
ItalySite Not Available
National Cancer Center Hospital East
Chiba, 277-8577
JapanSite Not Available
National Cancer Center Hospital East
Chiba 2113015, 277-8577
JapanSite Not Available
National Cancer Center Hospital East
Chiba-ken, 277-0882
JapanActive - Recruiting
Kagoshima University Hospital
Kagoshima, 890-8520
JapanActive - Recruiting
Kagoshima University Hospital
Kagoshima 1860827, 890-8520
JapanSite Not Available
Osaka Metropolitan University Hospital
Osaka, 545-8586
JapanActive - Recruiting
Osaka Metropolitan University Hospital
Osaka 1853909, 545-8586
JapanSite Not Available
Osaka City University Hospital
Osaka-fu, 545-8586
JapanSite Not Available
Nippon Medical School Hospital
Tokyo, 113-8603
JapanActive - Recruiting
Nippon Medical School Hospital
Tokyo 1850147, 113-8603
JapanSite Not Available
Mie University Hospital
Tsu, 514-0001
JapanActive - Recruiting
Mie University Hospital
Tsu 1849796, 514-0001
JapanSite Not Available
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid 3117735, 28041
SpainSite Not Available
Hospital Universitari I Politecnic La Fe
Valencia, 46026
SpainActive - Recruiting
Hospital Universitari I Politecnic La Fe
Valencia 2509954, 46026
SpainSite Not Available
Guys and St Thomas Nhs Foundation Trust
London, SE1 9RT
United KingdomActive - Recruiting
Guys and St Thomas Nhs Foundation Trust
London 2643743, SE1 9RT
United KingdomSite Not Available
The Christie Nhs Foundation Trust Uk
Manchester, M20 4BV
United KingdomActive - Recruiting
The Christie Nhs Foundation Trust Uk
Manchester 2643123, M20 4BV
United KingdomSite Not Available
University of Oxford
Oxford, OX3 7LE
United KingdomActive - Recruiting
University of Oxford
Oxford 2640729, OX3 7LE
United KingdomSite Not Available

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