Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
279 participants
INTERVENTIONAL
2015-03-05
2027-09-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination
All participants will receive either ruxolitinib monotherapy or ruxolitinib in combination with panobinostat, at the same dose/schedule that they were taking in the parent study.
ruxolitinib
ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study
panobinostat
panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study
Interventions
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ruxolitinib
ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study
panobinostat
panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator
3. Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
4. Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat
Exclusion Criteria
2. Patient's indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat.
3. Pregnant or nursing (lactating) women.
4. Female patients of childbearing potential (e.g. are menstruating) who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception, throughout the study and for up to 30 days after stopping study treatment.
1 Month
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharma, A.G
Role: STUDY_DIRECTOR
Novartis Pharma, A.G.
Locations
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Novartis Investigative Site
Darlinghurst, New South Wales, Australia
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Herston, Queensland, Australia
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Wooloongabba, Queensland, Australia
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Bedford Park, South Australia, Australia
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Box Hill, Victoria, Australia
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Clayton, Victoria, Australia
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Franston, Victoria, Australia
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Perth, Western Australia, Australia
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St Leonards, , Australia
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Leuven, Vlaams Brabant, Belgium
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Antwerp, , Belgium
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Bruges, , Belgium
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Liège, , Belgium
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Pleven, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Toronto, Ontario, Canada
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Viña del Mar, Región de Valparaíso, Chile
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Santiago, RM, Chile
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Santiago, , Chile
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Hangzhou, Zhejiang, China
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Beijing, , China
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Paris, , France
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Dresden, Saxony, Germany
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Jena, Thuringia, Germany
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Aachen, , Germany
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Dresden, , Germany
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Hamburg, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Ulm, , Germany
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Athens, , Greece
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Pátrai, , Greece
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Debrecen, Hajdu Bihar Megye, Hungary
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Budapest, , Hungary
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Kaposvár, , Hungary
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Kecskemét, , Hungary
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Szeged, , Hungary
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Szombathely, , Hungary
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Pune, Maharashtra, India
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Afula, , Israel
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Jerusalem, , Israel
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Ancona, AN, Italy
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Bari, BA, Italy
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Bologna, BO, Italy
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Brescia, BS, Italy
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San Giovanni Rotondo, FG, Italy
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Florence, FI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Rozzano, MI, Italy
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Palermo, PA, Italy
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Pavia, PV, Italy
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Reggio Calabria, RC, Italy
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Roma, RM, Italy
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Orbassano, TO, Italy
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Varese, VA, Italy
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Napoli, , Italy
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Nagoya, Aichi-ken, Japan
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Nagoya, Aichi-ken, Japan
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Fukuoka, Fukuoka, Japan
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Sapporo, Hokkaido, Japan
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Isehara, Kanagawa, Japan
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Suita, Osaka, Japan
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Bunkyo Ku, Tokyo, Japan
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Osaka, , Japan
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Beirut, , Lebanon
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Monterrey, Nuevo León, Mexico
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Gliwice, Silesian Voivodeship, Poland
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Wroclaw, , Poland
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Lisbon, , Portugal
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Lisbon, , Portugal
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Petrozavodsk, , Russia
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Saint Petersburg, , Russia
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Pretoria, Gauteng, South Africa
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Soweto, Gauteng, South Africa
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Cape Town, Western, South Africa
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Pretoria, , South Africa
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Seoul, Korea, South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Salamanca, Castille and León, Spain
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Barcelona, Catalonia, Spain
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Pamplona, Navarre, Spain
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Huddinge, , Sweden
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Luleå, , Sweden
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Lund, , Sweden
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Uddevalla, , Sweden
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Bangkok, , Thailand
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Istanbul, Fatih, Turkey (Türkiye)
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Kayseri, Melikgazi, Turkey (Türkiye)
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Ankara, Sihhiye-Altindag, Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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2014-003527-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CINC424A2X01B
Identifier Type: -
Identifier Source: org_study_id
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