CINC424A2X01B Rollover Protocol

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 Identifier: NCT02386800

Novartis Reference Number: CINC424A2X01B

Last Update: Jan 19, 2023

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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.

Condition

Primary Myelofibrosis

Polycythemia Vera

Graft Versus Host Disease

Acute Myeloid Leukemia

Thalassemia

Phase

Phase 4

Overall status

Recruiting

Start date

Mar 05, 2015

Completion date

Sep 16, 2027

Gender

All

Age(s)

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

Interventions

Drug

ruxolitinib

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

Drug

panobinostat

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

Eligibility Criteria

Key Inclusion criteria:

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:

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.