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Clinical Trials in India / NCT02386800
Active, not recruiting Phase 4

CINC424A2X01B Rollover Protocol

NCT02386800 · tracked via the Priya Life Science India tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 4
Started
2015-03-05
Last updated
2026-08-20

Condition(s) studied

Primary MyelofibrosisPolycythemia VeraGraft Versus Host DiseaseAcute Myeloid LeukemiaThalassemia

Investigational drug(s) / intervention(s)

ruxolitinibpanobinostat

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

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

Study 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.

Eligibility

Sex
ALL
Min age
1 Month
Max age
100 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (97)

FacilityCityRegionStatus
Novartis Investigative Site Darlinghurst New South Wales
Novartis Investigative Site Herston Queensland
Novartis Investigative Site Wooloongabba Queensland
Novartis Investigative Site Bedford Park South Australia
Novartis Investigative Site Box Hill Victoria
Novartis Investigative Site Clayton Victoria
Novartis Investigative Site Franston Victoria
Novartis Investigative Site Perth Western Australia
Novartis Investigative Site St Leonards Australia
Novartis Investigative Site Leuven Vlaams Brabant
Novartis Investigative Site Antwerp Belgium
Novartis Investigative Site Bruges Belgium
Novartis Investigative Site Liège Belgium
Novartis Investigative Site Pleven Bulgaria
Novartis Investigative Site Plovdiv Bulgaria
Novartis Investigative Site Sofia Bulgaria
Novartis Investigative Site Toronto Ontario
Novartis Investigative Site Santiago RM
Novartis Investigative Site Viña del Mar Valparaiso
Novartis Investigative Site Santiago Chile
Novartis Investigative Site Hangzhou Zhejiang
Novartis Investigative Site Beijing China
Novartis Investigative Site Paris France
Novartis Investigative Site Dresden Saxony
Novartis Investigative Site Jena Thuringia
Novartis Investigative Site Aachen Germany
Novartis Investigative Site Dresden Germany
Novartis Investigative Site Hamburg Germany
Novartis Investigative Site Magdeburg Germany
Novartis Investigative Site Mainz Germany
Novartis Investigative Site Ulm Germany
Novartis Investigative Site Athens Greece
Novartis Investigative Site Pátrai Greece
Novartis Investigative Site Debrecen Hajdu Bihar Megye
Novartis Investigative Site Budapest Hungary
Novartis Investigative Site Kaposvár Hungary
Novartis Investigative Site Kecskemét Hungary
Novartis Investigative Site Szeged Hungary
Novartis Investigative Site Szombathely Hungary
Novartis Investigative Site Pune Maharashtra

+ 57 more sites — see the full list on the official registry below.

On this site

📄 Jakafi (ruxolitinib) drug profile →

More Novartis Pharmaceuticals trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02386800 on ClinicalTrials.gov ↗ ← All trials in India