Rollover An Open Label, Multi-center, Phase IV Rollover Protocol for Patients Who Have Completed a Global Novartis or Incyte Sponsored Ruxolitinib (INC424) or Ruxolitinib and Panobinostat (LBH589) Combination Study and Are Judged by the Investigator to Benefit From Continued Treatment
- Conditions
- SplenomegalyR16.1
- Registration Number
- LBCTR2020011380
- Lead Sponsor
- ovartis Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 4
Inclusion Criteria:
1.Patient is currently enrolled in a Novartis GDD or GMA-sponsored or Incyte-sponsored clinical study (where Incyte can delegate the sponsorship to a preferred CRO, if applicable) that is approved to enroll into this rollover study, is 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.Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
5.Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat
6.Written informed consent obtained prior to enrolling in roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness.
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 local country
3.Patient has participated in a combination trial (other than the specified panobinostat and ruxolitinib combination trial) where ruxolitinib was dispensed in combination with another study medication and the patient is still receiving combination therapy.
4.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until termination of gestation, confirmed by a positive hCG lab test.
5.Women of child-bearing potential, unless they are using highly effective methods of contraception throughout the study duration inclusive of the 30-day safety follow up.
6.Female patients between = 12 and < 18 years of age and of childbearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of highly effective contraception as defined below, throughout the study and for up to 30 days after stopping treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ame: Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: through study completion estimated to be approximately 10 years ];Timepoints: through study completion ;Measure: Adverse Events
- Secondary Outcome Measures
Name Time Method ame: 1.To evaluate clinical benefit as assessed by the investigator;Timepoints: approximately 10 years;Measure: clinical benefit as assessed by the investigator