Clinical trial · Interventional
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
NCT02386800CI-TRIAL-00122978active not recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Graft Versus Host Disease | — | UNRESOLVED | — |
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
| Primary Myelofibrosis | Primary Myelofibrosis | ONTOLOGY_EXACT | 0.98 |
| Thalassemia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| panobinostat | Drug | Panobinostat | ALIAS |
| ruxolitinib | Drug | Ruxolitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Ruxolitinib monotherapy or ruxolitinib plus panobinostat in combination
- description
- 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.
- interventionNames
- Drug: ruxolitinib
- Drug: panobinostat
Primary outcomes (1)
- measure
- Incidence and severity of AEs and SAEs
- timeFrame
- 12 years
- description
- 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 outcomes (2)
- measure
- Percentage of participants with clinical benefit as assessed by the investigator at scheduled visits.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Month
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.