CINC424A2X01B Rollover Protocol

NCT ID: NCT02386800

Last Updated: 2025-11-26

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

279 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-05

Study Completion Date

2027-09-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

ruxolitinib

Intervention Type DRUG

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

panobinostat

Intervention Type DRUG

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

Intervention Type DRUG

panobinostat

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

Intervention Type DRUG

Other Intervention Names

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INC424 Jakavi LBH589 Farydak

Eligibility Criteria

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Inclusion Criteria

1. 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.
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

1. Patient has been permanently discontinued from study treatment in the parent study due to any reason.
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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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)

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Countries

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Australia Belgium Bulgaria Canada Chile China France Germany Greece Hungary India Israel Italy Japan Lebanon Mexico Poland Portugal Russia South Africa South Korea Spain Sweden Thailand Turkey (Türkiye)

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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