safety and efficacy of ruxolitinib in anemic myelofibrosis patients

Phase 1

• Conditions: treatment of anemic myelofibrosis patients; MedDRA version: 19.0 Level: LLT Classification code 10074692 Term: Post essential thrombocythaemia myelofibrosis System Organ Class: 100000004864; MedDRA version: 19.0 Level: LLT Classification code 10074691 Term: Post polycythaemia vera myelofibrosis System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-003552-75-HU
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-11-29
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

- Male or female patients aged = 18 years of age.
- Patients must be diagnosed with PMF, according to the 2016 revised International Standard Criteria (Arber et al, 2016), PPV MF or PET-MF (Barosi 2008), irrespective of JAK2 mutation status.
- Patients with palpable splenomegaly that is equal to or greater than 5 cm below the left costal margin.
- Patients with a hemoglobin less than 10 g/dL
- Patients with a history of transfusions must have a documented transfusion record in the previous 12 weeks to baseline.
- Patients with a peripheral blood blast percentage count of < 10%.

Additional inclusion criteria as per full protocol may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Patients with prior treatment with any JAK1 or JAK2 inhibitor.
- Patients with inadequate bone marrow reserve at baseline visit asdemonstrated by at least one of the following:
? ANC that is = 1,000/µL.
? Platelet count that is <50,000/µL without the assistance of growth factors, thrombopoietic factors or platelet transfusions.
? Hemoglobin count that is = 6.5 g/dL despite transfusions.
- Patients with severely impaired renal function
- Patients with inadequate liver function
- Patients being treated concurrently with a strong (potent) systemic inhibitor or inducer of CYP3A4 at the time of Screening
- Acute viral hepatitis or active chronic hepatitis B or C infection.
- History of progressive multifocal leuko-encephalopathy (PML)

Additional exclusion criteria as per full protocol may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified