CINC424A2X01B Rollover Protocol

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02386800
Phase
PHASE4
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
1 Month - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • ruxolitinib — DRUG
    ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study
  • panobinostat — DRUG
    panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study

Study Details

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.

Key Dates

Start date
Mar 5, 2015
Status verified
May 2026
Primary completion
Sep 16, 2027
Completion
Sep 16, 2027

Study Design

Enrollment
279 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination
    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.

Primary Outcome Measure

Incidence and severity of AEs and SAEs [ Time Frame: 12 years ]

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