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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003527-22 | EudraCT Number |
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This is a long term safety study for patients that have been treated with either ruxolitinib or a combination of ruxolitinib with panobinostat, on a Novartis or Incyte sponsored study, who have been judged by the study Investigator to benefit from ongoing treatment.
This roll-over protocol allows patients from multiple protocols, who are still receiving clinical benefit, to continue their treatment in one study that covers multiple indications. The population for the roll-over study should be consistent with the population defined in the parent studies. The primary eligibility criteria for a patient to enter the roll-over protocol is the participation and completion of a Novartis or Incyte study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. Efficacy parameters will not be measured; however safety data and an evaluation of clinical benefit will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ruxolitinib | Drug | ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of AEs and SAEs | The incidence of treatment-emergent AEs and SAEs (new or worsening from baseline) will be summarized by system organ class and/or preferred term, severity (based on CTCAE grades). | 12 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits. | The analysis of clinical benefit will be descriptive only and cannot be compared to efficacy results of other studies. In addition, as clinical benefit was only added in protocol amendment 1, it may not be available for all participants. | 12 years |
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Key Inclusion criteria:
Key Exclusion criteria:
Other protocol-defined Inclusion / Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharma, A.G | Novartis Pharma, A.G. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Darlinghurst | New South Wales | 2010 | Australia | ||
| Novartis Investigative Site |
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| panobinostat | Drug | panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study |
|
|
| Incidence and severity of AEs and SAEs by treatment group | AEs and SAEs for participants in the Safety group will be listed and summarized by treatment group (ruxolitinib monotherapy / ruxolitinib + panobinostat combination) | 12 years |
| Herston |
| Queensland |
| 4029 |
| Australia |
| Novartis Investigative Site | Wooloongabba | Queensland | 4102 | Australia |
| Novartis Investigative Site | Bedford Park | South Australia | 5041 | Australia |
| Novartis Investigative Site | Box Hill | Victoria | 3128 | Australia |
| Novartis Investigative Site | Clayton | Victoria | 3168 | Australia |
| Novartis Investigative Site | Franston | Victoria | 3199 | Australia |
| Novartis Investigative Site | Perth | Western Australia | 6000 | Australia |
| Novartis Investigative Site | St Leonards | 2065 | Australia |
| Novartis Investigative Site | Leuven | Vlaams Brabant | 3000 | Belgium |
| Novartis Investigative Site | Antwerp | 2020 | Belgium |
| Novartis Investigative Site | Bruges | 8000 | Belgium |
| Novartis Investigative Site | Liège | 4000 | Belgium |
| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
| Novartis Investigative Site | Plovdiv | 4002 | Bulgaria |
| Novartis Investigative Site | Sofia | 1431 | Bulgaria |
| Novartis Investigative Site | Toronto | Ontario | M5G 1X8 | Canada |
| Novartis Investigative Site | Santiago | RM | 7500922 | Chile |
| Novartis Investigative Site | Viña del Mar | Valparaiso | 2540364 | Chile |
| Novartis Investigative Site | Santiago | 8420383 | Chile |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310003 | China |
| Novartis Investigative Site | Beijing | 100730 | China |
| Novartis Investigative Site | Paris | 75475 | France |
| Novartis Investigative Site | Dresden | Saxony | 01307 | Germany |
| Novartis Investigative Site | Jena | Thuringia | 07740 | Germany |
| Novartis Investigative Site | Aachen | 52074 | Germany |
| Novartis Investigative Site | Dresden | 01307 | Germany |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Magdeburg | 39120 | Germany |
| Novartis Investigative Site | Mainz | 55131 | Germany |
| Novartis Investigative Site | Ulm | 89081 | Germany |
| Novartis Investigative Site | Athens | 115 27 | Greece |
| Novartis Investigative Site | Pátrai | 265 04 | Greece |
| Novartis Investigative Site | Debrecen | Hajdu Bihar Megye | 4032 | Hungary |
| Novartis Investigative Site | Budapest | H-1097 | Hungary |
| Novartis Investigative Site | Kaposvár | 7400 | Hungary |
| Novartis Investigative Site | Kecskemét | 6001 | Hungary |
| Novartis Investigative Site | Szeged | H 6725 | Hungary |
| Novartis Investigative Site | Szombathely | H-9700 | Hungary |
| Novartis Investigative Site | Pune | Maharashtra | 411004 | India |
| Novartis Investigative Site | Afula | 1834111 | Israel |
| Novartis Investigative Site | Jerusalem | 9112001 | Israel |
| Novartis Investigative Site | Ancona | AN | 60020 | Italy |
| Novartis Investigative Site | Bari | BA | 70124 | Italy |
| Novartis Investigative Site | Bologna | BO | 40138 | Italy |
| Novartis Investigative Site | Brescia | BS | 25123 | Italy |
| Novartis Investigative Site | San Giovanni Rotondo | FG | 71013 | Italy |
| Novartis Investigative Site | Florence | FI | 50134 | Italy |
| Novartis Investigative Site | Milan | MI | 20122 | Italy |
| Novartis Investigative Site | Milan | MI | 20132 | Italy |
| Novartis Investigative Site | Milan | MI | 20162 | Italy |
| Novartis Investigative Site | Rozzano | MI | 20089 | Italy |
| Novartis Investigative Site | Palermo | PA | 90146 | Italy |
| Novartis Investigative Site | Pavia | PV | 27100 | Italy |
| Novartis Investigative Site | Reggio Calabria | RC | 89124 | Italy |
| Novartis Investigative Site | Roma | RM | 00161 | Italy |
| Novartis Investigative Site | Orbassano | TO | 10043 | Italy |
| Novartis Investigative Site | Varese | VA | 21100 | Italy |
| Novartis Investigative Site | Naples | 80138 | Italy |
| Novartis Investigative Site | Nagoya | Aichi-ken | 453-8511 | Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 4668560 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060-8648 | Japan |
| Novartis Investigative Site | Isehara | Kanagawa | 259-1193 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565-0871 | Japan |
| Novartis Investigative Site | Bunkyo Ku | Tokyo | 1138677 | Japan |
| Novartis Investigative Site | Fukuoka | 8128582 | Japan |
| Novartis Investigative Site | Osaka | 5458586 | Japan |
| Novartis Investigative Site | Beirut | 113-0236 | Lebanon |
| Novartis Investigative Site | Monterrey | Nuevo León | 64718 | Mexico |
| Novartis Investigative Site | Gliwice | Silesian Voivodeship | 44-101 | Poland |
| Novartis Investigative Site | Wroclaw | 50 367 | Poland |
| Novartis Investigative Site | Lisbon | 1099-023 | Portugal |
| Novartis Investigative Site | Lisbon | 1649-035 | Portugal |
| Novartis Investigative Site | Moscow | 125167 | Russia |
| Novartis Investigative Site | Moscow | 125284 | Russia |
| Novartis Investigative Site | Moscow | 129110 | Russia |
| Novartis Investigative Site | Petrozavodsk | 185019 | Russia |
| Novartis Investigative Site | Saint Petersburg | 197022 | Russia |
| Novartis Investigative Site | Pretoria | Gauteng | 0181 | South Africa |
| Novartis Investigative Site | Soweto | Gauteng | 2013 | South Africa |
| Novartis Investigative Site | Cape Town | Western | 7800 | South Africa |
| Novartis Investigative Site | Pretoria | 0027 | South Africa |
| Novartis Investigative Site | Seoul | 03080 | South Korea |
| Novartis Investigative Site | Seoul | 03722 | South Korea |
| Novartis Investigative Site | Seoul | 06591 | South Korea |
| Novartis Investigative Site | Barcelona | Catalonia | 08003 | Spain |
| Novartis Investigative Site | Pamplona | Navarre | 31008 | Spain |
| Novartis Investigative Site | Salamanca | 37007 | Spain |
| Novartis Investigative Site | Huddinge | SE-14186 | Sweden |
| Novartis Investigative Site | Luleå | SE 971 80 | Sweden |
| Novartis Investigative Site | Lund | SE-221 85 | Sweden |
| Novartis Investigative Site | Uddevalla | 451 80 | Sweden |
| Novartis Investigative Site | Bangkok | 10700 | Thailand |
| Novartis Investigative Site | Istanbul | Fatih | 34093 | Turkey (Türkiye) |
| Novartis Investigative Site | Kayseri | Melikgazi | 38039 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | Sihhiye-Altindag | 06230 | Turkey (Türkiye) |
| Novartis Investigative Site | Izmir | 35100 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| D011087 | Polycythemia Vera |
| D006086 | Graft vs Host Disease |
| D015470 | Leukemia, Myeloid, Acute |
| D013789 | Thalassemia |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019046 | Bone Marrow Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D007154 | Immune System Diseases |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C540383 | ruxolitinib |
| D000077767 | Panobinostat |
| ID | Term |
|---|---|
| D006877 | Hydroxamic Acids |
| D006898 | Hydroxylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002264 | Carboxylic Acids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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