Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT02386800

CINC424A2X01B Rollover Protocol

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

Sex: All
Ages: 1 Month – 100 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 296
Sponsor: Novartis Pharmaceuticals

Location: Novartis Investigative Site Darlinghurst New South Wales

Summary

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 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02386800). StuddyBuddy aggregates publicly available trial information.