CINC424A2X01B Rollover Protocol

Last updated: November 24, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

4

Condition

Myelofibrosis

Acute Myeloid Leukemia

Bone Marrow Disorder

Treatment

panobinostat

ruxolitinib

Clinical Study ID

NCT02386800
CINC424A2X01B
2014-003527-22
  • Ages 1-100
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Key Inclusion criteria:

  1. Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsoredclinical study, are receiving either ruxolitinib or combination of ruxolitinib andpanobinostat, and fulfilled all of the requirements of the parent protocol.

  2. Patient is currently benefiting from the treatment with ruxolitinib monotherapy orcombination of ruxolitinib and panobinostat, as determined by the investigator

  3. Patient has demonstrated compliance, as assessed by the investigator, with theparent study protocol requirements

  4. Patient currently has no evidence of progressive disease, as determined by theinvestigator, following previous treatment with ruxolitinib or combination ofruxolitinib and panobinostat

Exclusion

Key Exclusion criteria:

  1. Patient has been permanently discontinued from study treatment in the parent studydue to any reason.

  2. Patient's indication is currently approved and reimbursed in the correspondingcountry 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 agreeto abstinence or, if sexually active, do not agree to the use of highly effectivecontraception, throughout the study and for up to 30 days after stopping studytreatment.

Other protocol-defined Inclusion / Exclusion criteria may apply.

Study Design

Total Participants: 279
Treatment Group(s): 2
Primary Treatment: panobinostat
Phase: 4
Study Start date:
March 05, 2015
Estimated Completion Date:
September 16, 2027

Study Description

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.

Connect with a study center

  • Novartis Investigative Site

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • Novartis Investigative Site

    Kogarah, New South Wales 2217
    Australia

    Site Not Available

  • Novartis Investigative Site

    Darlinghurst 2169378, New South Wales 2155400 2010
    Australia

    Site Not Available

  • Novartis Investigative Site

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Novartis Investigative Site

    Herston 6931014, Queensland 2152274 4029
    Australia

    Site Not Available

  • Novartis Investigative Site

    Wooloongabba, Queensland 2152274 4102
    Australia

    Site Not Available

  • Novartis Investigative Site

    Bedford Park, South Australia 5041
    Australia

    Site Not Available

  • Novartis Investigative Site

    Bedford Park 2076918, South Australia 2061327 5041
    Australia

    Site Not Available

  • Novartis Investigative Site

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Novartis Investigative Site

    Clayton, Victoria 3168
    Australia

    Site Not Available

  • Novartis Investigative Site

    Box Hill 2174360, Victoria 2145234 3128
    Australia

    Site Not Available

  • Novartis Investigative Site

    Clayton 2171400, Victoria 2145234 3168
    Australia

    Site Not Available

  • Novartis Investigative Site

    Franston, Victoria 2145234 3199
    Australia

    Site Not Available

  • Novartis Investigative Site

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Novartis Investigative Site

    Perth 2063523, Western Australia 2058645 6000
    Australia

    Site Not Available

  • Novartis Investigative Site

    St Leonards, 2065
    Australia

    Site Not Available

  • Novartis Investigative Site

    St Leonards 8029783, 2065
    Australia

    Site Not Available

  • Novartis Investigative Site

    Leuven 2792482, Vlaams Brabant 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Antwerp 2803138, 2020
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Antwerpen, 2020
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Bruges 2800931, 8000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Brugge, 8000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Leuven, 3000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Liege, 4000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Liège 2792413, 4000
    Belgium

    Site Not Available

  • Novartis Investigative Site

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Plovdiv 728193, 4002
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Sofia, 1413
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Sofia 727011, 1431
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Toronto 6167865, Ontario 6093943 M5G 1X8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Santiago, RM 7500922
    Chile

    Site Not Available

  • Novartis Investigative Site

    Viña del Mar 3868121, Región de Valparaíso 3868621 2540364
    Chile

    Site Not Available

  • Novartis Investigative Site

    Vina del Mar, Valparaiso 2540364
    Chile

    Site Not Available

  • Novartis Investigative Site

    Santiago 3871336, 8420383
    Chile

    Site Not Available

  • Novartis Investigative Site

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Novartis Investigative Site

    Hangzhou 1808926, Zhejiang 1784764 310003
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing, 100730
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing 1816670, 100730
    China

    Site Not Available

  • Novartis Investigative Site

    Copenhagen, DK-2100
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Copenhagen 2618425, DK-2100
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Paris 2988507, 75475
    France

    Site Not Available

  • Novartis Investigative Site

    Paris 10, 75475
    France

    Site Not Available

  • Novartis Investigative Site

    Paris Cedex 10, 75475
    France

    Site Not Available

  • Novartis Investigative Site

    Dresden 2935022, Saxony 2842566 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Jena 2895044, Thuringia 2822542 07740
    Germany

    Site Not Available

  • Novartis Investigative Site

    Aachen, 52074
    Germany

    Site Not Available

  • Novartis Investigative Site

    Aachen 3247449, 52074
    Germany

    Site Not Available

  • Novartis Investigative Site

    Dresden, 01307
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg, 20246
    Germany

    Site Not Available

  • Novartis Investigative Site

    Hamburg 2911298, 20246
    Germany

    Site Not Available

  • Novartis Investigative Site

    Jena, 07740
    Germany

    Site Not Available

  • Novartis Investigative Site

    Leipzig, 04103
    Germany

    Site Not Available

  • Novartis Investigative Site

    Magdeburg, 39120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Magdeburg 2874545, 39120
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mainz, 55131
    Germany

    Site Not Available

  • Novartis Investigative Site

    Mainz 2874225, 55131
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ulm, 89081
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ulm 2820256, 89081
    Germany

    Site Not Available

  • Novartis Investigative Site

    Goudi-Athens, GR 115 27
    Greece

    Site Not Available

  • Novartis Investigative Site

    Patra - RIO, GR 265 04
    Greece

    Site Not Available

  • Novartis Investigative Site

    Athens, 115 27
    Greece

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  • Novartis Investigative Site

    Athens 264371, 115 27
    Greece

    Site Not Available

  • Novartis Investigative Site

    Patras, 265 00
    Greece

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  • Novartis Investigative Site

    Pátrai 255683, 265 04
    Greece

    Site Not Available

  • Novartis Investigative Site

    Debrecen 721472, Hajdu Bihar Megye 4032
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Budapest, H-1097
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Budapest 3054643, H-1097
    Hungary

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  • Novartis Investigative Site

    Debrecen, 4032
    Hungary

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  • Novartis Investigative Site

    Kaposvar, 7400
    Hungary

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  • Novartis Investigative Site

    Kaposvár 3050616, 7400
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Kecskemet, 6001
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Kecskemét 3050434, 6001
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szeged, H 6725
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szeged 715429, H 6725
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szombathely, H-9700
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szombathely 3044310, H-9700
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Pune, Maharashtra 411004
    India

    Site Not Available

  • Novartis Investigative Site

    Pune 1259229, Maharashtra 1264418 411004
    India

    Site Not Available

  • Novartis Investigative Site

    Afula, 1834111
    Israel

    Site Not Available

  • Novartis Investigative Site

    Afula 295740, 1834111
    Israel

    Site Not Available

  • Novartis Investigative Site

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Novartis Investigative Site

    Jerusalem 281184, 9112001
    Israel

    Site Not Available

  • Novartis Investigative Site

    Ancona, AN 60126
    Italy

    Site Not Available

  • Novartis Investigative Site

    Ancona 3183089, AN 60126
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bari, BA 70124
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bari 3182351, BA 70124
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bologna, BO 40138
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bologna 3181928, BO 40138
    Italy

    Site Not Available

  • Novartis Investigative Site

    Brescia, BS 25123
    Italy

    Site Not Available

  • Novartis Investigative Site

    Brescia 3181554, BS 25123
    Italy

    Site Not Available

  • Novartis Investigative Site

    San Giovanni Rotondo, FG 71013
    Italy

    Site Not Available

  • Novartis Investigative Site

    San Giovanni Rotondo 3168234, FG 71013
    Italy

    Site Not Available

  • Novartis Investigative Site

    Firenze, FI 50134
    Italy

    Site Not Available

  • Novartis Investigative Site

    Florence 3176959, FI 50134
    Italy

    Site Not Available

  • Novartis Investigative Site

    Cagliari, ITA 09121
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milan 6951411, MI 20122
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20132
    Italy

    Site Not Available

  • Novartis Investigative Site

    Rozzano, MI 20089
    Italy

    Site Not Available

  • Novartis Investigative Site

    Rozzano 3168837, MI 20089
    Italy

    Site Not Available

  • Novartis Investigative Site

    Palermo, PA 90146
    Italy

    Site Not Available

  • Novartis Investigative Site

    Palermo 2523920, PA 90146
    Italy

    Site Not Available

  • Novartis Investigative Site

    Pavia, PV 27100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Pavia 3171366, PV 27100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Reggio Calabria, RC 89100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Reggio Calabria 2523630, RC 89124
    Italy

    Site Not Available

  • Novartis Investigative Site

    Roma, RM 00165
    Italy

    Site Not Available

  • Novartis Investigative Site

    Roma 8957247, RM 00161
    Italy

    Site Not Available

  • Novartis Investigative Site

    Orbassano, TO 10043
    Italy

    Site Not Available

  • Novartis Investigative Site

    Orbassano 3171986, TO 10043
    Italy

    Site Not Available

  • Novartis Investigative Site

    Varese, VA 21100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Varese 3164699, VA 21100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Napoli, 80138
    Italy

    Site Not Available

  • Novartis Investigative Site

    Napoli 9031661, 80138
    Italy

    Site Not Available

  • Novartis Investigative Site

    Nagoya, Aichi 453-8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Nagoya 1856057, Aichi-ken 1865694 453-8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuoka city, Fukuoka 812-8582
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuoka 1863967, Fukuoka 1863958 812-8582
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sapporo city, Hokkaido 060 8648
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sapporo 2128295, Hokkaido 2130037 060 8648
    Japan

    Site Not Available

  • Novartis Investigative Site

    Isehara, Kanagawa 259-1193
    Japan

    Site Not Available

  • Novartis Investigative Site

    Isehara 1861449, Kanagawa 1860291 259-1193
    Japan

    Site Not Available

  • Novartis Investigative Site

    Suita, Osaka 565 0871
    Japan

    Site Not Available

  • Novartis Investigative Site

    Suita city, Osaka 565 0871
    Japan

    Site Not Available

  • Novartis Investigative Site

    Suita 1851483, Osaka 1853904 565 0871
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo ku, Tokyo 113-8677
    Japan

    Site Not Available

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo 1850144 113-8677
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka, 545-8586
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka 1853909, 545-8586
    Japan

    Site Not Available

  • Novartis Investigative Site

    Seoul, 03080
    Korea, Republic of

    Site Not Available

  • Novartis Investigative Site

    Beirut, 1107 2020
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Beirut 276781, 113-0236
    Lebanon

    Site Not Available

  • Novartis Investigative Site

    Monterrey, Nuevo Leon 64718
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Monterrey 3995465, Nuevo León 3522542 64718
    Mexico

    Site Not Available

  • Novartis Investigative Site

    Gliwice 3099230, Silesian Voivodeship 3337497 44-101
    Poland

    Site Not Available

  • Novartis Investigative Site

    Gliwice, Slaskie 44-101
    Poland

    Site Not Available

  • Novartis Investigative Site

    Wroclaw, 50 367
    Poland

    Site Not Available

  • Novartis Investigative Site

    Wroclaw 3081368, 50 367
    Poland

    Site Not Available

  • Novartis Investigative Site

    Lisboa, 1649 035
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Lisbon 2267057, 1099-023
    Portugal

    Site Not Available

  • Novartis Investigative Site

    Moscow 524901, 125167
    Russia

    Site Not Available

  • Novartis Investigative Site

    Petrozavodsk 509820, 185019
    Russia

    Site Not Available

  • Novartis Investigative Site

    Saint Petersburg 498817, 197022
    Russia

    Site Not Available

  • Novartis Investigative Site

    Moscow, 125284
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Petrozavodsk, 185019
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Sain Petersburg, 197022
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Saint Petersburg, 197022
    Russian Federation

    Site Not Available

  • Novartis Investigative Site

    Bratislava, 833 40
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Bratislava 3060972, 833 40
    Slovakia

    Site Not Available

  • Novartis Investigative Site

    Soweto, Gauteng 2013
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Soweto 953781, Gauteng 1085594 2013
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Cape Town, Western 7800
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Cape Town 3369157, Western 7800
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Pretoria, 0027
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Pretoria 964137, 0027
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Novartis Investigative Site

    Salamanca, Castilla y Leon 37007
    Spain

    Site Not Available

  • Novartis Investigative Site

    Salamanca 3111108, Castille and León 3336900 37007
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona 3128760, Catalonia 3336901 08003
    Spain

    Site Not Available

  • Novartis Investigative Site

    Barcelona, Catalunya 08003
    Spain

    Site Not Available

  • Novartis Investigative Site

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Novartis Investigative Site

    Pamplona 3114472, Navarre 3115609 31008
    Spain

    Site Not Available

  • Novartis Investigative Site

    Huddinge, SE-14186
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Huddinge 2704620, SE-14186
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Lulea, SE 971 80
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Luleå 604490, SE 971 80
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Lund, SE-221 85
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Lund 2693678, SE-221 85
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Uddevalla, 451 80
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Uddevalla 2666670, 451 80
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Bangkok, 10700
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Bangkok 1609350, 10700
    Thailand

    Site Not Available

  • Novartis Investigative Site

    Ankara, 06230
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Istanbul, 34093
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Izmir, 35100
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Sihhiye/Ankara, 06100
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Talas / Kayseri, 38039
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Talas Kayseri, 38039
    Turkey

    Site Not Available

  • Novartis Investigative Site

    Istanbul 745044, Fatih 34093
    Turkey (Türkiye)

    Site Not Available

  • Novartis Investigative Site

    Kayseri 308464, Melikgazi 38039
    Turkey (Türkiye)

    Site Not Available

  • Novartis Investigative Site

    Ankara 323786, Sihhiye-Altindag 06230
    Turkey (Türkiye)

    Site Not Available

  • Novartis Investigative Site

    Izmir 311046, 35100
    Turkey (Türkiye)

    Site Not Available

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