An open label, multi-center, Phase IV roll-over protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study or a study of ruxolitinib in combination with panobinostat (LBH589) or siremadlin (HDM201) or rineterkib (LTT462) and are judged by the investigator to benefit from continued treatment.

ovartis Pharma Services AG0 个研究点目标入组 366 人开始时间: 2015年7月10日最近更新: 2024年4月2日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: ovartis Pharma Services AG
入组人数: 366

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•- 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, or combinations of
•ruxolitinib and siremadlin (HDM201), or ruxolitinib and rineterkib
•(LTT462), and fulfilled all of the requirements of the parent protocol.
•Please refer to the list of parent studies in Appendix 2.
•- Patient is currently benefiting from the treatment with ruxolitinib
•monotherapy or combination of ruxolitinib and panobinostat, or
•combinations of ruxolitinib and siremadlin (HDM201), or ruxolitinib and
•rineterkib (LTT462), 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, or
•combinations of ruxolitinib and siremadlin (HDM201), or ruxolitinib and
•rineterkib (LTT462)
•- 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

排除标准

•- 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.
•- Patient has participated in a combination study other than the
•CINC424H12201 platform study providing combinations of either
•ruxolitinib and siremadlin or ruxolitinib and rineterkib, where ruxolitinib
•was dispensed in combination with another study medication
•- Sexually active males, unless they use a condom during intercourse
•while taking siremadlin or rineterkib and for 2 weeks after siremadlin or
•rineterkib discontinuation, and thus do not attempt to father a child in
•this period. A condom is required to be used also by vasectomized men
•in order to prevent delivery of the drug via seminal fluid.
•- Had history of documented severe hypersensitivity
•reactions/immunogenicity to a prior biologic product in any treatment
•arm OR received a monoclonal antibody or immunoglobulin-based agent:
•For treatment arms with rineterkib or siremadlin arms within =4
•weeks of screening or =5 half-lives whichever is shorter for rineterkib or
•siremadlin arms

研究者

发起方

ovartis Pharma Services AG

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