Phase
Condition
Red Blood Cell Disorders
Leukemia (Pediatric)
Bone Marrow Disorder
Treatment
N/AClinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Patients who either completed the 12 months AOP2014 treatment arm of the PROUD-PVstudy, or are currently participating in the CONTINUATION-PV, and at the "EoT visit" (End of treatment visit) of the PROUD-PV study or two weeks after the last assessmentvisit of the CONTINUATION-PV study, fulfill at least one of the following criteria:
Normalization of at least two out of three main blood parameters (Hct (Hematocrit), PLTs (Platelets) and WBCs (white blood cells) if these parameterswere moderately increased (Hct<50%, WBCs<20 x 109/L, PLTs<600 x 109/L) atbaseline visit of the PROUD-PV study, OR
>35% decrease of at least two out of three main blood parameters (Hct, PLTs andWBCs) if these parameters were massively increased (Hct>50%, WBCs>20 x 109/L,PLTs >600 x 109/L), at baseline visit of the PROUD-PV study, OR
Normalization of spleen size, if spleen was enlarged at baseline visit of thePROUD-PV study, OR
Otherwise a clear, medically verified benefit from treatment with AOP2014 (e.g.normalization of disease-related micro-vasculatory symptoms, substantial decreaseof JAK2 (Januskinase 2) allelic burden).
- Signed written ICF.
Exclusion
Exclusion Criteria: Withdrawal criteria, as specified in the PROUD-PV and CONTINUATION-PV studies, whichmandate treatment discontinuation.
Non-recovery from the AOP2014 related toxicities to the grade (usually, Grade I) whichallows continuation of the treatment.
HADS (Hospital Anxiety and Depression Scale) score of 11 or higher on either or bothof the subscales, and /or development or worsening of clinically significantdepression or suicidal thoughts.
Progressive and clinically significant increase of liver enzyme levels despite dosereduction, or if such increase is accompanied by increased bilirubin level, any signsor symptoms of a clinically significant autoimmune disease.
Clinically significant development of a new ophthalmologic disorder, or worsening of apre-existing one, during the study.
Loss of efficacy of AOP2014 or any comparable situation where no further benefits oftreatment continuation are expected by the investigator.
Study Design
Study Description
Connect with a study center
LKH Graz
Graz,
AustriaSite Not Available
University Hospital Innsbruck
Innsbruck,
AustriaSite Not Available
Elisabethinen Hospital Linz
Linz,
AustriaSite Not Available
Salzburg Regional Hospital
Salzburg,
AustriaSite Not Available
Hanusch Hospital
Vienna,
AustriaSite Not Available
Medical University Vienna
Vienna,
AustriaSite Not Available
Hospital Wels-Grieskirchen
Wels,
AustriaSite Not Available
Specialized Hospital for Active Treatment of Hematological Diseases
Sofia,
BulgariaSite Not Available
Multiprofile Hospital for Active Treatment - Hristo Botev, Vratsa, First Department of Internal Medicine
Vratsa,
BulgariaSite Not Available
University Hospital Brno
Brno,
Czech RepublicSite Not Available
University Hospital Hradec Kralove
Hradec Kralove,
Czech RepublicSite Not Available
Institute of Hematology and Blood Transfusion
Prague,
Czech RepublicSite Not Available
University Hospital Kralovske Vinohrady
Prague,
Czech RepublicSite Not Available
University Hospital Motol
Prague,
Czech RepublicSite Not Available
Institute Paoli-Calmettes
Marseilles,
FranceSite Not Available
Hospital Saint-Louis
Paris,
FranceSite Not Available
Clinical Research Center CIC
Poitiers,
FranceSite Not Available
St Istvan and St Laszlo Hospital of Budapest
Budapest,
HungarySite Not Available
University of Debrecen
Debrecen,
HungarySite Not Available
Bekes County Pandy Kalman Hospital, 1st Department of Medicine, Hematology
Gyula,
HungarySite Not Available
Kaposi Mor County Teaching Hospital
Kaposvar,
HungarySite Not Available
University of Szeged, Albert Szent-Gyorgyi Clinical Center, Koranyi fasor 6
Szeged,
HungarySite Not Available
Andrzej Mielecki Independent Public Clinical Hospital of Medical University of Silesia in Katowice
Katowice,
PolandSite Not Available
University Hospital in Cracow
Krakow,
PolandSite Not Available
Independent Public Teaching Hospital No.1 in Lublin
Lublin,
PolandSite Not Available
Fryderyk Chopin Provincial Specialized Hospital
Rzeszow,
PolandSite Not Available
Nicolaus Copernicus Municipal Specialist Hospital
Torun,
PolandSite Not Available
Institute of Hematology and Transfusion Medicine
Warsaw,
PolandSite Not Available
University Hospital with Outpatient Clinic F.D. Roosevelt
Banska Bystrica,
SlovakiaSite Not Available
Saint Cyril and Metod University Hospital Bratislava
Bratislava,
SlovakiaSite Not Available
Cherkasy Regional Oncology Center, Regional Treatment and Diagnostics Hematology Center
Cherkasy,
UkraineSite Not Available
Dnipropetrovsk City Multispecialty Clinical Hospital #4
Dnipropetrovsk,
UkraineSite Not Available
National Research Center for Radiation Medicine, Institute of Clinical Radiology
Kiev,
UkraineSite Not Available
Institute of Blood Pathology and Transfusion Medicine
Lviv,
UkraineSite Not Available
O.F. Herbachevskyi Regional Clinical Hospital
Zhytomyr,
UkraineSite Not Available
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