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CINC424A2X01B Rollover Protocol
CINC424A2X01B Rollover Protocol

NCT02386800

Active Not RecruitingPhase 4

Sponsor: Novartis Pharmaceuticals

Conditions: Primary Myelofibrosis, Polycythemia Vera, Graft Versus Host Disease, Acute Myeloid Leukemia, Thalassemia

Interventions: ruxolitinib, panobinostat

Countries: Australia, Belgium, Bulgaria, Canada, Chile, China, France, Germany

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.

Eligibility overview

Sex: ALL

Age: 1 Month to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (97)
  • Darlinghurst, New South Wales, Australia
  • Herston, Queensland, Australia
  • Wooloongabba, Queensland, Australia
  • Bedford Park, South Australia, Australia
  • Box Hill, Victoria, Australia
  • Clayton, Victoria, Australia
  • Franston, Victoria, Australia
  • Perth, Western Australia, Australia
  • St Leonards, Australia
  • Leuven, Vlaams Brabant, Belgium
  • Antwerp, Belgium
  • Bruges, Belgium
  • Liège, Belgium
  • Pleven, Bulgaria
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Toronto, Ontario, Canada
  • Santiago, RM, Chile
  • Viña del Mar, Valparaiso, Chile
  • Santiago, Chile
  • Hangzhou, Zhejiang, China
  • Beijing, China
  • Paris, France
  • Dresden, Saxony, Germany
  • Jena, Thuringia, Germany
  • Aachen, Germany
  • Dresden, Germany
  • Hamburg, Germany
  • Magdeburg, Germany
  • Mainz, Germany
  • + 67 more on CT.gov