Primary MyelofibrosisPhase 4NCT02386800
CINC424A2X01B Rollover Protocol
A Phase 4 study testing ruxolitinib and panobinostat in people with Primary Myelofibrosis and Polycythemia Vera, run by Novartis Pharmaceuticals at 97 sites in 25 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 100 years
- Conditions the study is for
- Primary Myelofibrosis, Polycythemia Vera, Graft Versus Host Disease
- What is being tested?
- ruxolitinib and panobinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 97 sitesin 25 countries
- Study dates
- 5 Mar 2015to 5 Apr 2032
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
- Other protocol-defined Inclusion / Exclusion criteria may apply.
Trial locations and contacts
97 sites in 25 countries.
97 sites in 25 countries
Italy17 sites
Novartis Investigative Site
Ancona, AN, 60020
Novartis Investigative Site
Bari, BA, 70124
Novartis Investigative Site
Bologna, BO, 40138
Novartis Investigative Site
Brescia, BS, 25123
Novartis Investigative Site
Florence, FI, 50134
Novartis Investigative Site
Milan, MI, 20122
Novartis Investigative Site
Milan, MI, 20132
Novartis Investigative Site
Milan, MI, 20162
Novartis Investigative Site
Naples, 80138
Novartis Investigative Site
Orbassano, TO, 10043
Novartis Investigative Site
Palermo, PA, 90146
Novartis Investigative Site
Pavia, PV, 27100
Novartis Investigative Site
Reggio Calabria, RC, 89124
Novartis Investigative Site
Roma, RM, 00161
Novartis Investigative Site
Rozzano, MI, 20089
Novartis Investigative Site
San Giovanni Rotondo, FG, 71013
Novartis Investigative Site
Varese, VA, 21100
Australia9 sites
Novartis Investigative Site
Bedford Park, South Australia, 5041
Novartis Investigative Site
Box Hill, Victoria, 3128
Novartis Investigative Site
Clayton, Victoria, 3168
Novartis Investigative Site
Darlinghurst, New South Wales, 2010
Novartis Investigative Site
Franston, Victoria, 3199
Novartis Investigative Site
Herston, Queensland, 4029
Novartis Investigative Site
Perth, Western Australia, 6000
Novartis Investigative Site
St Leonards, 2065
Novartis Investigative Site
Wooloongabba, Queensland, 4102
Germany8 sites
Novartis Investigative Site
Aachen, 52074
Novartis Investigative Site
Dresden, Saxony, 01307
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Hamburg, 20246
Novartis Investigative Site
Jena, Thuringia, 07740
Novartis Investigative Site
Magdeburg, 39120
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Ulm, 89081
Japan8 sites
Novartis Investigative Site
Bunkyo Ku, Tokyo, 1138677
Novartis Investigative Site
Fukuoka, 8128582
Novartis Investigative Site
Isehara, Kanagawa, 2591193
Novartis Investigative Site
Nagoya, Aichi-ken, 4538511
Novartis Investigative Site
Nagoya, Aichi-ken, 4668560
Novartis Investigative Site
Osaka, 5458586
Novartis Investigative Site
Sapporo, Hokkaido, 0608648
Novartis Investigative Site
Suita, Osaka, 5650871
Hungary6 sites
Novartis Investigative Site
Budapest, 1097
Novartis Investigative Site
Debrecen, Hajdu Bihar Megye, 4032
Novartis Investigative Site
Kaposvár, 7400
Novartis Investigative Site
Kecskemét, 6001
Novartis Investigative Site
Szeged, H 6725
Novartis Investigative Site
Szombathely, 9700
Russia5 sites
Novartis Investigative Site
Moscow, 125167
Novartis Investigative Site
Moscow, 125284
Novartis Investigative Site
Moscow, 129110
Novartis Investigative Site
Petrozavodsk, 185019
Novartis Investigative Site
Saint Petersburg, 197022
Belgium4 sites
Novartis Investigative Site
Antwerp, 2020
Novartis Investigative Site
Bruges, 8000
Novartis Investigative Site
Leuven, Vlaams Brabant, 3000
Novartis Investigative Site
Liège, 4000
South Africa4 sites
Novartis Investigative Site
Cape Town, Western, 7800
Novartis Investigative Site
Pretoria, Gauteng, 0181
Novartis Investigative Site
Pretoria, 0027
Novartis Investigative Site
Soweto, Gauteng, 2013
Sweden4 sites
Novartis Investigative Site
Huddinge, SE-14186
Novartis Investigative Site
Luleå, 971 80
Novartis Investigative Site
Lund, 221 85
Novartis Investigative Site
Uddevalla, 451 80
Turkey (Türkiye)4 sites
Novartis Investigative Site
Ankara, Sihhiye Altindag, 06230
Novartis Investigative Site
Istanbul, Fatih, 34093
Novartis Investigative Site
Izmir, 35100
Novartis Investigative Site
Kayseri, Melikgazi, 38039
Bulgaria3 sites
Novartis Investigative Site
Pleven, 5800
Novartis Investigative Site
Plovdiv, 4002
Novartis Investigative Site
Sofia, 1431
Chile3 sites
Novartis Investigative Site
Santiago, RM, 7500922
Novartis Investigative Site
Santiago, 8420383
Novartis Investigative Site
Viña del Mar, Valparaiso, 2540364
South Korea3 sites
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 06591
Spain3 sites
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Pamplona, Navarre, 31008
Novartis Investigative Site
Salamanca, 37007
China2 sites
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Hangzhou, Zhejiang, 310003
Greece2 sites
Novartis Investigative Site
Athens, 115 27
Novartis Investigative Site
Pátrai, 265 04
Israel2 sites
Novartis Investigative Site
Afula, 1834111
Novartis Investigative Site
Jerusalem, 9112001
Poland2 sites
Novartis Investigative Site
Gliwice, Silesian Voivodeship, 44-101
Novartis Investigative Site
Wroclaw, 50-367
Portugal2 sites
Novartis Investigative Site
Lisbon, 1099-023
Novartis Investigative Site
Lisbon, 1649-035
About this study
Official title: 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.
Read the 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.
- Conditions
- Primary Myelofibrosis, Polycythemia Vera, Graft Versus Host Disease, Acute Myeloid Leukemia, Thalassemia
- Being tested
- ruxolitinib, panobinostat
- 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
- Medical subject headings
- Primary Myelofibrosis, Polycythemia Vera, Graft vs Host Disease, Leukemia, Myeloid, Acute, Thalassemia, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ruxolitinibDrug
Also called INC424, Jakavi
ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study
panobinostatDrug
Also called LBH589, Farydak
panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ruxolitinib; Drug: panobinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 years
Secondary outcomes (2)
Percentage of participants with clinical benefit as assessed by the investigator at scheduled visits.
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.
Measured: 12 years
Incidence and severity of AEs and SAEs by treatment group
AEs and SAEs for participants in the Safety group will be listed and summarized by treatment group (ruxolitinib monotherapy / ruxolitinib + panobinostat combination)
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study start5 Mar 2015
- Primary completion5 Apr 2032 (estimated)
- Study completion5 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharma, A.G, Study director, Novartis Pharma, A.G.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02386800
- Sponsor's protocol ID
- CINC424A2X01B
- Other IDs
- 2014-003527-22, 2024-515283-31-00, 2014
- Status last verified
- Oct 2026
- First submitted
- 6 Mar 2015
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02386800
- Acronym / sponsor ID
- CINC424A2X01B
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2015 (actual)
- Primary completion
- 5 Apr 2032 (estimated)
- Study completion
- 5 Apr 2032 (estimated)
- First posted
- 12 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination | Experimental | Drug: ruxolitinib, Drug: panobinostatAll 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. |
Who may qualify
- Ages
- 1 month to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
- Other protocol-defined Inclusion / Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ruxolitinibAlso: INC424, Jakaviruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study | Drug | Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination |
| panobinostatAlso: LBH589, Farydakpanobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study | Drug | Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination |
Primary outcome
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).
2 secondary outcomes
Percentage of participants with clinical benefit as assessed by the investigator at scheduled visits.
Time frame: 12 years
Incidence and severity of AEs and SAEs by treatment group
Time frame: 12 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharma, A.G study director
Novartis Pharma, A.G.
97 sites in 25 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ruxolitinib and panobinostat in people with Primary Myelofibrosis and Polycythemia Vera, run by Novartis Pharmaceuticals at 97 sites in 25 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in Italy, Australia, Germany, Japan, Hungary and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of AEs and SAEs (time frame: 12 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.