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

An open label, multi-center, Phase IV rollover protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study or ruxolitinib and panobinostat (LBH589) combination study, and are judged by the investigator to benefit from continued treatment

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/05/033375

Enrollment

453

Registered

2021-05-05

Start date

Unknown

Completion date

Unknown

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D898- Other specified disorders involving the immune mechanism, not elsewhere classified

Interventions

Intervention1: oral pediatric formulation: Subjects below 12 years to be given oral formulation as per parent protocol. Patient to continue taking medication till patient benefits. Intervention2: rux

Eligibility

Inclusion criteria

Inclusion criteria: Patient is currently enrolled in a Novartis-sponsored Global Drug Development (GDD) or Global Medical Affairs (GMA) study or Incyte-sponsored study (where Incyte can delegate the sponsorship to a preferred CRO, if applicable) that is approved to enroll into this rollover study, and 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.

Exclusion criteria

Exclusion criteria: 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 local country for ruxolitinib monotherapy or other study drugs in the combination treatment (panobinostat).

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events as a Measure of Safety and TolerabilityTimepoint: 5 years	—

Secondary

Measure	Time frame
The secondary objective of the study is to evaluate clinical benefit as assessed by the investigator. Proportion of patients with clinical benefit as assessed by the investigator will be summarized at scheduled visitsTimepoint: 5 Years	—

Countries

Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lebanon, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Republic of Korea, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom

Contacts

Public ContactMurugananthan K

Novartis Healthcare PVT LTD

murugananthan.k@novartis.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026