A study for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study or ruxolitinib and panobinostat (LBH589) combination study and are judged by the investigator to benefit from continued treatment
- Conditions
- This roll-over study is designed to accept patients with varied disease origins. Please refer to the parent protocol for the disease background information and rationale for use of ruxolitinib in their individual indications.MedDRA version: 21.0Level: LLTClassification code 10074689Term: Post polycythemia vera myelofibrosisSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10074690Term: Post essential thrombocythemia myelofibrosisSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10074691Term: Post polycythaemia vera myelofibrosisSystem Organ Class: 100000004864MedDRA version: 21.0Level: LLTClassification code 10074692Term: Post essential thrombocythaemia myelofibrosisSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10036061Term: Polycythemia veraSystem Organ Class: 100000004864MedDRA version: 20.1Level: LLTClassification code 10054658Term: ThalassemiaSystem Organ Class: 100000004850MedDRA version: 20.1Level: PTClassification code 10066264Term: Acute graft versus host disease in intestineSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.1Level: PTClassification code 10066262Term: Acute graft versus host disease in skinSystem Organ Class: 10021428 - Immune system disordersMedDRA version: 20.1Level: PTClassification code 10066263Term: Acute graft versus host disease in liverSystem Organ Class: 10021428 - Immune system disorders
- Registration Number
- EUCTR2014-003527-22-BG
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 366
- 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, and 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
- Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures
- Patient currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with ruxolitinib or combination of ruxolitinib and panobinostat
- 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.
Note 1: If the patient is a minor, the parent who signs the informed consent for the minor must be a legally recognized parent or guardian. Where deemed appropriate by the clinician, and the child's parent or guardian, the child will also be included in the alldiscussions about the trials and the minor aged 12 and above assent will be obtained. The parent or guardian will sign on the designated line on the ICF attesting to the fact that the child
had given consent.
Note 2: if the minor is an adolescent female, she will be informed during the assent process that for safety purpose, a pregnancy test is required.
She will also be told that if it is positive, she will be counseled and will be assisted in telling her parents. If the minor does not want to proceed,
she will be advised not to sign consent and her enrollment in this protocol will end.
Are the trial subjects under 18? yes
Number of subjects for this age range: 38
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 196
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 132
- 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 (if the patient is receiving combination treatment in the parent study)
- Patient has participated in a combination trial other than the panobinostat and ruxolitinib combination trial (CLBH589X2106), where ruxolitinib was dispensed in combination with another study medication and the patient is still receiving combination therapy.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- 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 as defined below, throughout the study and for up to 30 days after stopping study treatment. If local regulations are more stringent than the contraception methods listed in the protocol and in Section 7.1.7 to prevent pregnancy, the local regulations will apply as described in the ICF.
Highly effective contraception methods include: see protocol.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate long term safety data i.e. SAEs and AEs.;Secondary Objective: To evaluate clinical benefit as assessed by the investigator<br><br>Other secondary:<br>- To evaluate long term safety data by ruxolitinib in monotherapy or in combination with panobinostat<br>- To evaluate clinical benefit by ruxolitinib in monotherapy or in combination with panobinostat;Primary end point(s): Frequency and severity of SAEs/AEs<br>;Timepoint(s) of evaluation of this end point: through study completion estimated to be approximately 12 years
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits<br><br>Other secondary:<br>- frequency and severity of AEs/SAEs<br>- Proportion of patients with clinical benefit as assessed by the<br>investigator at scheduled visits;Timepoint(s) of evaluation of this end point: at every visit that occur every 12 weeks until EOT<br>other secondary:<br>- at every visit that occur every 12 weeks until End of Trial<br>- at every visit that occur every 12 weeks until End of Trial