CINC424A2X01B Rollover Protocol

NCT02386800 | Active Not Recruiting Phase 4

• 2 other identifiers: CINC424A2X01B2014-003527-22
• Study Type: interventional
• Target: 279
• Locations: 25 countries
• Sites: 97

Brief 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.

Conditions

Primary Myelofibrosis; Polycythemia Vera; Graft Versus Host Disease; Acute Myeloid Leukemia; Thalassemia

Keywords

Myelofibrosis; MF; Polycythemia vera; PV; Acute Graft versus Host Disease; aGvHD; Chronic Graft versus Host Disease; cGvHD; Acute Myeloid Leukemia; AML; Thalassemia; Ruxolitinib; INC424; Panobinostat; LBH589

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits.

  12 years

• Incidence and severity of AEs and SAEs by treatment group

  12 years

Study Arms (1)

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.

Drug: ruxolitinib; Drug: panobinostat

Interventions

ruxolitinib DRUG

ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study

Also known as: INC424, Jakavi

Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination

panobinostat DRUG

panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study

Also known as: LBH589, Farydak

Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination

Eligibility Criteria

• Age: 1 Month - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study, are receiving either ruxolitinib or combination of ruxolitinib and panobinostat, and fulfilled all of the requirements of the parent protocol.
• Patient is currently benefiting from the treatment with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat, as determined by the investigator
• Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements
• Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat

You may not qualify if:

• Patient has been permanently discontinued from study treatment in the parent study due to any reason.
• Patient's indication is currently approved and reimbursed in the corresponding country for ruxolitinib monotherapy or combination of ruxolitinib and panobinostat.
• Pregnant or nursing (lactating) women.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (97)

Novartis Investigative Site

Darlinghurst, New South Wales, 2010, Australia

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Novartis Investigative Site

Herston, Queensland, 4029, Australia

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Novartis Investigative Site

Wooloongabba, Queensland, 4102, Australia

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Novartis Investigative Site

Bedford Park, South Australia, 5041, Australia

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Novartis Investigative Site

Box Hill, Victoria, 3128, Australia

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Novartis Investigative Site

Clayton, Victoria, 3168, Australia

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Novartis Investigative Site

Franston, Victoria, 3199, Australia

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Novartis Investigative Site

Perth, Western Australia, 6000, Australia

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Novartis Investigative Site

St Leonards, 2065, Australia

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Novartis Investigative Site

Leuven, Vlaams Brabant, 3000, Belgium

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Novartis Investigative Site

Antwerp, 2020, Belgium

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Novartis Investigative Site

Bruges, 8000, Belgium

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Novartis Investigative Site

Liège, 4000, Belgium

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Novartis Investigative Site

Pleven, 5800, Bulgaria

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Novartis Investigative Site

Plovdiv, 4002, Bulgaria

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Novartis Investigative Site

Sofia, 1431, Bulgaria

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Novartis Investigative Site

Toronto, Ontario, M5G 1X8, Canada

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Novartis Investigative Site

Viña del Mar, Región de Valparaíso, 2540364, Chile

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Novartis Investigative Site

Santiago, RM, 7500922, Chile

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Novartis Investigative Site

Santiago, 8420383, Chile

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Novartis Investigative Site

Hangzhou, Zhejiang, 310003, China

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Novartis Investigative Site

Beijing, 100730, China

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Novartis Investigative Site

Paris, 75475, France

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Novartis Investigative Site

Dresden, Saxony, 01307, Germany

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Novartis Investigative Site

Jena, Thuringia, 07740, Germany

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Novartis Investigative Site

Aachen, 52074, Germany

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Novartis Investigative Site

Dresden, 01307, Germany

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Novartis Investigative Site

Hamburg, 20246, Germany

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Novartis Investigative Site

Magdeburg, 39120, Germany

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Novartis Investigative Site

Mainz, 55131, Germany

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Novartis Investigative Site

Ulm, 89081, Germany

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Novartis Investigative Site

Athens, 115 27, Greece

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Novartis Investigative Site

Pátrai, 265 04, Greece

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Novartis Investigative Site

Debrecen, Hajdu Bihar Megye, 4032, Hungary

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Novartis Investigative Site

Budapest, H-1097, Hungary

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Novartis Investigative Site

Kaposvár, 7400, Hungary

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Novartis Investigative Site

Kecskemét, 6001, Hungary

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Novartis Investigative Site

Szeged, H 6725, Hungary

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Novartis Investigative Site

Szombathely, H-9700, Hungary

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Novartis Investigative Site

Pune, Maharashtra, 411004, India

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Novartis Investigative Site

Afula, 1834111, Israel

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Novartis Investigative Site

Jerusalem, 9112001, Israel

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Novartis Investigative Site

Ancona, AN, 60126, Italy

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Novartis Investigative Site

Bari, BA, 70124, Italy

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Novartis Investigative Site

Bologna, BO, 40138, Italy

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Novartis Investigative Site

Brescia, BS, 25123, Italy

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Novartis Investigative Site

San Giovanni Rotondo, FG, 71013, Italy

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Novartis Investigative Site

Florence, FI, 50134, Italy

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Novartis Investigative Site

Milan, MI, 20122, Italy

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Novartis Investigative Site

Milan, MI, 20132, Italy

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Novartis Investigative Site

Milan, MI, 20162, Italy

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Novartis Investigative Site

Rozzano, MI, 20089, Italy

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Novartis Investigative Site

Palermo, PA, 90146, Italy

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Novartis Investigative Site

Pavia, PV, 27100, Italy

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Novartis Investigative Site

Reggio Calabria, RC, 89124, Italy

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Novartis Investigative Site

Roma, RM, 00161, Italy

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Novartis Investigative Site

Orbassano, TO, 10043, Italy

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Novartis Investigative Site

Varese, VA, 21100, Italy

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Novartis Investigative Site

Naples, 80138, Italy

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Novartis Investigative Site

Nagoya, Aichi-ken, 453-8511, Japan

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Novartis Investigative Site

Nagoya, Aichi-ken, 4668560, Japan

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Novartis Investigative Site

Sapporo, Hokkaido, 0608648, Japan

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Novartis Investigative Site

Isehara, Kanagawa, 259-1193, Japan

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Novartis Investigative Site

Suita, Osaka, 5650871, Japan

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Novartis Investigative Site

Bunkyo Ku, Tokyo, 1138677, Japan

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Novartis Investigative Site

Fukuoka, 8128582, Japan

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Novartis Investigative Site

Osaka, 5458586, Japan

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Novartis Investigative Site

Beirut, 113-0236, Lebanon

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Novartis Investigative Site

Monterrey, Nuevo León, 64718, Mexico

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Novartis Investigative Site

Gliwice, Silesian Voivodeship, 44-101, Poland

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Novartis Investigative Site

Wroclaw, 50 367, Poland

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Novartis Investigative Site

Lisbon, 1099-023, Portugal

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Novartis Investigative Site

Lisbon, 1649-035, Portugal

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Novartis Investigative Site

Moscow, 125167, Russia

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Novartis Investigative Site

Moscow, 125284, Russia

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Novartis Investigative Site

Moscow, 129110, Russia

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Novartis Investigative Site

Petrozavodsk, 185019, Russia

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Novartis Investigative Site

Saint Petersburg, 197022, Russia

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Novartis Investigative Site

Pretoria, Gauteng, 0181, South Africa

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Novartis Investigative Site

Soweto, Gauteng, 2013, South Africa

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Novartis Investigative Site

Cape Town, Western, 7800, South Africa

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Novartis Investigative Site

Pretoria, 0027, South Africa

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Novartis Investigative Site

Seoul, Korea, 03080, South Korea

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Novartis Investigative Site

Seoul, 03722, South Korea

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Novartis Investigative Site

Seoul, 06591, South Korea

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Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

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Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

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Novartis Investigative Site

Salamanca, 37007, Spain

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Novartis Investigative Site

Huddinge, SE-14186, Sweden

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Novartis Investigative Site

Luleå, SE 971 80, Sweden

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Novartis Investigative Site

Lund, SE-221 85, Sweden

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Novartis Investigative Site

Uddevalla, 451 80, Sweden

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Novartis Investigative Site

Bangkok, 10700, Thailand

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Novartis Investigative Site

Istanbul, Fatih, 34093, Turkey (Türkiye)

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Novartis Investigative Site

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

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Novartis Investigative Site

Ankara, Sihhiye-Altindag, 06230, Turkey (Türkiye)

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Novartis Investigative Site

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Primary Myelofibrosis; Polycythemia Vera; Graft vs Host Disease; Leukemia, Myeloid, Acute; Thalassemia; Bronchiolitis Obliterans Syndrome

Interventions

ruxolitinib; Panobinostat

Condition Hierarchy (Ancestors)

Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Immune System Diseases; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic Acids; Hydroxylamines; Amines; Organic Chemicals; Hydroxy Acids; Carboxylic Acids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Novartis Pharma, A.G

  Novartis Pharma, A.G.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2015
• First Posted: March 12, 2015
• Study Start: March 5, 2015
• Primary Completion (Estimated): September 16, 2027
• Study Completion (Estimated): September 16, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

PL (2); IN (1); TH (1); BE (4); TU (4); LE (1); AU (9); CA (1); HU (6); PT (2); ZA (4); BU (3); GR (2); FR (1); IL (2); IT (17); CL (3); DE (8); JP (8); CN (2); ME (1); RU (5); KR (3); SE (4); ES (3)