CINC424A2X01B Rollover Protocol

August 18, 2026 updated by: Novartis Pharmaceuticals

Open Label, Multi-center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
279

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +81337978748

Study Locations

  • Australia
      • St Leonards, Australia, 2065
        • Novartis Investigative Site
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • Novartis Investigative Site
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Novartis Investigative Site
      • Wooloongabba, Queensland, Australia, 4102
        • Novartis Investigative Site
    • South Australia
      • Bedford Park, South Australia, Australia, 5041
        • Novartis Investigative Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Novartis Investigative Site
      • Clayton, Victoria, Australia, 3168
        • Novartis Investigative Site
      • Franston, Victoria, Australia, 3199
        • Novartis Investigative Site
    • Western Australia
      • Perth, Western Australia, Australia, 6000
        • Novartis Investigative Site
  • Belgium
      • Antwerp, Belgium, 2020
        • Novartis Investigative Site
      • Bruges, Belgium, 8000
        • Novartis Investigative Site
      • Liège, Belgium, 4000
        • Novartis Investigative Site
    • Vlaams Brabant
      • Leuven, Vlaams Brabant, Belgium, 3000
        • Novartis Investigative Site
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Novartis Investigative Site
      • Plovdiv, Bulgaria, 4002
        • Novartis Investigative Site
      • Sofia, Bulgaria, 1431
        • Novartis Investigative Site
  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • Novartis Investigative Site
  • Chile
      • Santiago, Chile, 8420383
        • Novartis Investigative Site
    • RM
      • Santiago, RM, Chile, 7500922
        • Novartis Investigative Site
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2540364
        • Novartis Investigative Site
  • China
      • Beijing, China, 100730
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Novartis Investigative Site
  • France
      • Paris, France, 75475
        • Novartis Investigative Site
  • Germany
      • Aachen, Germany, 52074
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Novartis Investigative Site
      • Magdeburg, Germany, 39120
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Ulm, Germany, 89081
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Novartis Investigative Site
    • Thuringia
      • Jena, Thuringia, Germany, 07740
        • Novartis Investigative Site
  • Greece
      • Athens, Greece, 115 27
        • Novartis Investigative Site
      • Pátrai, Greece, 265 04
        • Novartis Investigative Site
  • Hungary
      • Budapest, Hungary, 1097
        • Novartis Investigative Site
      • Kaposvár, Hungary, 7400
        • Novartis Investigative Site
      • Kecskemét, Hungary, 6001
        • Novartis Investigative Site
      • Szeged, Hungary, H 6725
        • Novartis Investigative Site
      • Szombathely, Hungary, H-9700
        • Novartis Investigative Site
    • Hajdu Bihar Megye
      • Debrecen, Hajdu Bihar Megye, Hungary, 4032
        • Novartis Investigative Site
  • India
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Novartis Investigative Site
  • Israel
      • Afula, Israel, 1834111
        • Novartis Investigative Site
      • Jerusalem, Israel, 9112001
        • Novartis Investigative Site
  • Italy
      • Naples, Italy, 80138
        • Novartis Investigative Site
    • AN
      • Ancona, AN, Italy, 60020
        • Novartis Investigative Site
    • BA
      • Bari, BA, Italy, 70124
        • Novartis Investigative Site
    • BO
      • Bologna, BO, Italy, 40138
        • Novartis Investigative Site
    • BS
      • Brescia, BS, Italy, 25123
        • Novartis Investigative Site
    • FG
      • San Giovanni Rotondo, FG, Italy, 71013
        • Novartis Investigative Site
    • FI
      • Florence, FI, Italy, 50134
        • Novartis Investigative Site
    • MI
      • Milan, MI, Italy, 20162
        • Novartis Investigative Site
      • Milan, MI, Italy, 20132
        • Novartis Investigative Site
      • Milan, MI, Italy, 20122
        • Novartis Investigative Site
      • Rozzano, MI, Italy, 20089
        • Novartis Investigative Site
    • PA
      • Palermo, PA, Italy, 90146
        • Novartis Investigative Site
    • PV
      • Pavia, PV, Italy, 27100
        • Novartis Investigative Site
    • RC
      • Reggio Calabria, RC, Italy, 89124
        • Novartis Investigative Site
    • RM
      • Roma, RM, Italy, 00161
        • Novartis Investigative Site
    • TO
      • Orbassano, TO, Italy, 10043
        • Novartis Investigative Site
    • VA
      • Varese, VA, Italy, 21100
        • Novartis Investigative Site
  • Japan
      • Fukuoka, Japan, 8128582
        • Novartis Investigative Site
      • Osaka, Japan, 5458586
        • Novartis Investigative Site
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 453-8511
        • Novartis Investigative Site
      • Nagoya, Aichi-ken, Japan, 4668560
        • Novartis Investigative Site
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Novartis Investigative Site
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Novartis Investigative Site
    • Osaka
      • Suita, Osaka, Japan, 5650871
        • Novartis Investigative Site
    • Tokyo
      • Bunkyo Ku, Tokyo, Japan, 1138677
        • Novartis Investigative Site
  • Lebanon
      • Beirut, Lebanon, 113-0236
        • Novartis Investigative Site
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64718
        • Novartis Investigative Site
  • Poland
      • Wroclaw, Poland, 50-367
        • Novartis Investigative Site
    • Silesian Voivodeship
      • Gliwice, Silesian Voivodeship, Poland, 44-101
        • Novartis Investigative Site
  • Portugal
      • Lisbon, Portugal, 1099-023
        • Novartis Investigative Site
      • Lisbon, Portugal, 1649-035
        • Novartis Investigative Site
  • Russia
      • Moscow, Russia, 125167
        • Novartis Investigative Site
      • Moscow, Russia, 125284
        • Novartis Investigative Site
      • Moscow, Russia, 129110
        • Novartis Investigative Site
      • Petrozavodsk, Russia, 185019
        • Novartis Investigative Site
      • Saint Petersburg, Russia, 197022
        • Novartis Investigative Site
  • South Africa
      • Pretoria, South Africa, 0027
        • Novartis Investigative Site
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0181
        • Novartis Investigative Site
      • Soweto, Gauteng, South Africa, 2013
        • Novartis Investigative Site
    • Western
      • Cape Town, Western, South Africa, 7800
        • Novartis Investigative Site
  • South Korea
      • Seoul, South Korea, 03080
        • Novartis Investigative Site
      • Seoul, South Korea, 03722
        • Novartis Investigative Site
      • Seoul, South Korea, 06591
        • Novartis Investigative Site
  • Spain
      • Salamanca, Spain, 37007
        • Novartis Investigative Site
    • Catalonia
      • Barcelona, Catalonia, Spain, 08003
        • Novartis Investigative Site
    • Navarre
      • Pamplona, Navarre, Spain, 31008
        • Novartis Investigative Site
  • Sweden
      • Huddinge, Sweden, SE-14186
        • Novartis Investigative Site
      • Luleå, Sweden, SE 971 80
        • Novartis Investigative Site
      • Lund, Sweden, 221 85
        • Novartis Investigative Site
      • Uddevalla, Sweden, 451 80
        • Novartis Investigative Site
  • Thailand
      • Bangkok, Thailand, 10700
        • Novartis Investigative Site
  • Turkey (Türkiye)
      • Izmir, Turkey (Türkiye), 35100
        • Novartis Investigative Site
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34093
        • Novartis Investigative Site
    • Melikgazi
      • Kayseri, Melikgazi, Turkey (Türkiye), 38039
        • Novartis Investigative Site
    • Sihhiye-Altindag
      • Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key 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

Key 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.

Other protocol-defined Inclusion / Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Drug: ruxolitinib
ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study
Other Names:
  • Jakavi
  • INC424
Drug: panobinostat
panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study
Other Names:
  • Farydak
  • LBH589

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of AEs and SAEs
Time Frame: 12 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of AEs and SAEs by treatment group
Time Frame: 12 years
AEs and SAEs for participants in the Safety group will be listed and summarized by treatment group (ruxolitinib monotherapy / ruxolitinib + panobinostat combination)
12 years
Percentage of participants with clinical benefit as assessed by the investigator at scheduled visits.
Time Frame: 12 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Novartis Pharma, A.G, Novartis Pharma, A.G.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 5, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CINC424A2X01B
  • 2014-003527-22 (EudraCT Number)
  • 2024-515283-31-00 (Registry Identifier: EU CTIS)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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