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CLINICAL STUDY · NCT02386800

CINC424A2X01B Rollover Protocol

Active, not recruitingPhase 4Interventional

Sponsored by Novartis Pharmaceuticals

Condition
Primary Myelofibrosis, Polycythemia Vera, Graft Versus Host Disease, Acute Myeloid Leukemia, Thalassemia
Study locations
97 reported sites
Study updated
19 Oct 2026
Source
ClinicalTrials.gov

Overall study status is shown above. Individual hospitals may have a different recruitment status.

THE STUDY

About this study

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.
Full 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
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.

PARTICIPATION

Who may participate

Minimum age
1 Month
Maximum age
100 Years
Sex eligibility
All sexes
Healthy volunteers
Not accepted

Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.

Full inclusion and exclusion criteria
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.

NEAR YOU

Study locations worldwide

97 sites

Check the individual site’s status and contact the listed study team for current availability.

Novartis Investigative Site

Not reported

Darlinghurst, New South Wales, 2010, Australia

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Herston, Queensland, 4029, Australia

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Wooloongabba, Queensland, 4102, Australia

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Bedford Park, South Australia, 5041, Australia

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Box Hill, Victoria, 3128, Australia

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Franston, Victoria, 3199, Australia

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Perth, Western Australia, 6000, Australia

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Leuven, Vlaams Brabant, 3000, Belgium

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Viña del Mar, Valparaiso, 2540364, Chile

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Debrecen, Hajdu Bihar Megye, 4032, Hungary

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

San Giovanni Rotondo, FG, 71013, Italy

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Monterrey, Nuevo León, 64718, Mexico

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Gliwice, Silesian Voivodeship, 44-101, Poland

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Pretoria, Gauteng, 0181, South Africa

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Soweto, Gauteng, 2013, South Africa

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Cape Town, Western, 7800, South Africa

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Istanbul, Fatih, 34093, Turkey (Türkiye)

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Kayseri, Melikgazi, 38039, Turkey (Türkiye)

Contact details are not published in this record. Check official study record ↗

Novartis Investigative Site

Not reported

Ankara, Sihhiye Altindag, 06230, Turkey (Türkiye)

Contact details are not published in this record. Check official study record ↗

WHAT IS BEING STUDIED

Treatments and study groups

Interventions

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

Study groups: Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination

Other names: INC424, Jakavi

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

Study groups: Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination

Other names: LBH589, Farydak

Study groups

Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combinationExperimental
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.

Interventions: Drug: ruxolitinib, Drug: panobinostat

RESEARCH DETAILS

Study design

Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Study model
Single group
Masking
None (open label)
Enrolment
279 participants · Actual

TIMELINE & MEASURES

Dates and outcomes

Study started
5 Mar 2015 · Actual
Primary completion
5 Apr 2032 · Estimated
Study completion
5 Apr 2032 · Estimated
First registered
12 Mar 2015 · Estimated
Last registry update
19 Oct 2026 · Actual
Status last verified
Oct 2026
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).

Time frame: 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.

Time frame: 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)

Time frame: 12 years

STUDY TEAM

Sponsor and contacts

Lead sponsor
Novartis Pharmaceuticals
Sponsor type
Industry
Collaborators
Not reported
Organisation study ID
CINC424A2X01B

Central study contacts

No central contact is currently reported. Check the site contacts or the official record.

Study officials
Novartis Pharma, A.GStudy director · Novartis Pharma, A.G.

Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.

FURTHER READING

Results, documents and references

No results are posted in this registry record

This does not mean the study has no findings. Results may not yet have been submitted or published here.

No study documents are listed in this record.

Source: ClinicalTrials.gov · Data fetched 21 Oct 2026, 18:43 GMT+0530

Registry data timestamp: 2026-10-21T09:00:05

Registry content is reformatted for readability; original study text is not rewritten. Missing information is labelled “Not reported”. Records are supplied by study sponsors or investigators and can change.

ClinicalTrials.gov does not endorse PharmaBharat. Listing a study does not mean it has been evaluated or approved by a government agency. Information is for research awareness and is not medical advice. Data source terms · Registry disclaimer

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