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Active, Not Recruiting

NCT Number: NCT02386800

CINC424A2X01B Rollover Protocol

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Primary Myelofibrosis Acute Myeloid Leukemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Bone Marrow Diseases Bone Marrow Neoplasms Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Graft Versus Host Disease Graft vs Host Disease Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Hemoglobinopathies Immune System Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Lung Diseases Lung Diseases, Obstructive Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Organizing Pneumonia Polycythemia Vera Respiratory Tract Diseases Thalassemia

Age range

1 month–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Darlinghurst, New South Wales, Australia

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About this study

This roll-over protocol allows patients from multiple protocols, who are still receiving clinical benefit, to continue their treatment in one study that covers multiple indications. The population for the roll-over study should be consistent with the population defined in the parent studies. The primary eligibility criteria for a patient to enter the roll-over protocol is the participation and completion of a Novartis or Incyte study with ruxolitinib monotherapy or combination of ruxolitinib and panobinostat. Efficacy parameters will not be measured; however safety data and an evaluation of clinical benefit will be collected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion criteria:

  • 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.
  • 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
  • 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:

  • 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.
  • Pregnant or nursing (lactating) women.
  • 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.

Treatment and study plan

Ruxolitinib

Drug

ruxolitinib tablets or pediatric oral solution - participants continue ruxolitinib as they received in parent study

Other names: INC424, Jakavi

Panobinostat

Drug

panobinostat capsules - participants to continue receiving panobinostat in combination with ruxolitinib as per the parent study

Other names: LBH589, Farydak

Primary outcomes

  1. Incidence and severity of AEs and SAEs

    Time frame: 12 years

    The incidence of treatment-emergent AEs and SAEs (new or worsening from baseline) will be summarized by system organ class and/or preferred term, severity (based on CTCAE grades).

Secondary outcomes

  1. Proportion of participants with clinical benefit as assessed by the investigator at scheduled visits.

    Time frame: 12 years

    The analysis of clinical benefit will be descriptive only and cannot be compared to efficacy results of other studies. In addition, as clinical benefit was only added in protocol amendment 1, it may not be available for all participants.

  2. Incidence and severity of AEs and SAEs by treatment group

    Time frame: 12 years

    AEs and SAEs for participants in the Safety group will be listed and summarized by treatment group (ruxolitinib monotherapy / ruxolitinib + panobinostat combination)

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Open Label, Multi-center, Phase IV Study of Ruxolitinib or Ruxolitinib and Panobinostat Combination, for Patients Who Have Completed Prior Global Novartis or Incyte Sponsored Studies

Important dates

Study start
2015
Primary completion
2027
Study completion
2032
First posted
Mar 12, 2015
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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