CINC424A2X01B Rollover Protocol

Phase 4

Active, not recruiting

• Conditions: Primary Myelofibrosis; Polycythemia Vera; Thalassemia; Acute Myeloid Leukemia; Graft Versus Host Disease
• Interventions: Drug: ruxolitinib; Drug: panobinostat

• Registration Number: NCT02386800
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

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.

Study Timeline

• Study Start: 2015-03-05
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-03-06
• Study First Posted: 2015-03-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-18
• Primary Completion: 2027-09-16
• Study Completion: 2027-09-16

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination	ruxolitinib	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.
Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination	panobinostat	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 Measures

Name	Time	Method
Incidence and severity of AEs and SAEs	12 years	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).

Secondary Outcome Measures

Name	Time	Method
Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits.	12 years	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.
Incidence and severity of AEs and SAEs by treatment group	12 years	AEs and SAEs for participants in the Safety group will be listed and summarized by treatment group (ruxolitinib monotherapy / ruxolitinib + panobinostat combination)

Trial Locations

Locations (1)

Novartis Investigative Site; 🇹🇷 Talas Kayseri, Turkey