CINC424A2X01B Rollover Protocol

Last updated: April 16, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

4

Condition

Red Blood Cell Disorders

Myelofibrosis

Thalassemia

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

    Herston, Queensland 4029
    Australia

    Site Not Available

  • Novartis Investigative Site

    Wooloongabba, Queensland 4102
    Australia

    Site Not Available

  • Novartis Investigative Site

    Bedford Park, South Australia 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

    Franston, Victoria 3199
    Australia

    Site Not Available

  • Novartis Investigative Site

    Perth, Western Australia 6000
    Australia

    Site Not Available

  • Novartis Investigative Site

    St Leonards, 2065
    Australia

    Site Not Available

  • Novartis Investigative Site

    Antwerpen, 2020
    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

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Plovdiv, 4002
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Sofia, 1413
    Bulgaria

    Site Not Available

  • Novartis Investigative Site

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Novartis Investigative Site

    Santiago, RM 7500922
    Chile

    Site Not Available

  • Novartis Investigative Site

    Vina del Mar, Valparaiso 2540364
    Chile

    Site Not Available

  • Novartis Investigative Site

    Hangzhou, Zhejiang 310003
    China

    Site Not Available

  • Novartis Investigative Site

    Beijing, 100730
    China

    Site Not Available

  • Novartis Investigative Site

    Copenhagen, DK-2100
    Denmark

    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

    Aachen, 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

    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

    Mainz, 55131
    Germany

    Site Not Available

  • Novartis Investigative Site

    Ulm, 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

    Site Not Available

  • Novartis Investigative Site

    Patras, 265 00
    Greece

    Site Not Available

  • Novartis Investigative Site

    Budapest, H-1097
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Debrecen, 4032
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Kaposvar, 7400
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Kecskemet, 6001
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szeged, H 6725
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Szombathely, H-9700
    Hungary

    Site Not Available

  • Novartis Investigative Site

    Pune, Maharashtra 411004
    India

    Site Not Available

  • Novartis Investigative Site

    Afula, 1834111
    Israel

    Site Not Available

  • Novartis Investigative Site

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Novartis Investigative Site

    Ancona, AN 60126
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bari, BA 70124
    Italy

    Site Not Available

  • Novartis Investigative Site

    Bologna, BO 40138
    Italy

    Site Not Available

  • Novartis Investigative Site

    Brescia, BS 25123
    Italy

    Site Not Available

  • Novartis Investigative Site

    San Giovanni Rotondo, FG 71013
    Italy

    Site Not Available

  • Novartis Investigative Site

    Firenze, FI 50134
    Italy

    Site Not Available

  • Novartis Investigative Site

    Cagliari, ITA 09121
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milano, MI 20162
    Italy

    Site Not Available

  • Novartis Investigative Site

    Rozzano, MI 20089
    Italy

    Site Not Available

  • Novartis Investigative Site

    Palermo, PA 90146
    Italy

    Site Not Available

  • Novartis Investigative Site

    Pavia, PV 27100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Reggio Calabria, RC 89100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Roma, RM 00161
    Italy

    Site Not Available

  • Novartis Investigative Site

    Orbassano, TO 10043
    Italy

    Site Not Available

  • Novartis Investigative Site

    Varese, VA 21100
    Italy

    Site Not Available

  • Novartis Investigative Site

    Napoli, 80138
    Italy

    Site Not Available

  • Novartis Investigative Site

    Nagoya, Aichi 453-8511
    Japan

    Site Not Available

  • Novartis Investigative Site

    Fukuoka city, Fukuoka 812-8582
    Japan

    Site Not Available

  • Novartis Investigative Site

    Sapporo city, Hokkaido 060 8648
    Japan

    Site Not Available

  • Novartis Investigative Site

    Isehara, Kanagawa 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

    Bunkyo ku, Tokyo 113-8677
    Japan

    Site Not Available

  • Novartis Investigative Site

    Osaka, 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

    Monterrey, Nuevo Leon 64718
    Mexico

    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

    Lisboa, 1649 035
    Portugal

    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

    Soweto, Gauteng 2013
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Cape Town, Western 7800
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Pretoria, 0027
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Salamanca, Castilla Y Leon 37007
    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

    Huddinge, SE-14186
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Lulea, SE 971 80
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Lund, SE-221 85
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Uddevalla, 451 80
    Sweden

    Site Not Available

  • Novartis Investigative Site

    Bangkok, 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

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