Combination Therapy with Interferon-Alpha2a and Ruxolitinibin Newly Diagnosed Patients with Polycythemia Vera.A Danish Safety and Efficacy Study.

Phase 1

• Conditions: Polycythemia Vera; MedDRA version: 20.1Level: LLTClassification code 10036061Term: Polycythemia veraSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-004150-13-DK
• Lead Sponsor: Zealand University hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-31
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Age = 18 years AND
2. A confirmed diagnosis of PV according to the WHO 2016 criteria AND
3. Biochemical evidence of active disease as defined by
a) Elevated hematocrit and/or red cell count and/or
b) Leucocyte count > 10 x 109/L and /or
c) Platelet count > 400 x 109/L.
OR
4. Hypermetabolic symptoms such as weight loss (> 10% within 6 months), night sweats and
subfebrilia (temperature> 38 º C for more than 2 weeks without signs of infection OR
5. Pruritus OR
6. Symptomatic splenomegaly OR
7. Presence of previous thrombosis

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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

1. Patients of childbearing potential without a negative pregnancy test prior to initiation of study drug. Participants must use contraceptives during the entire study period*.
2. Other active malignancy within the past 5 years (not including non-melanoma skin cancer and prostate cancer without need for treatment).
3. ECOG function scores> / = 3
4. Serum creatinine more than 2 x ULN
5. Total serum bilirubin greater than 1.5 x ULN
6. Plasma ALAT more than 3 x ULN
7. Former psychiatric disorder (depression diagnosed by a psychiatrist)
8. Uncontrolled metabolic disease.
9. Severe heart disease (heart failure NYHA class 3-4).
10. Severe myelosuppression. (WBC<1.5 Mill/L, PLA<100)
11. Chronic hepatitis with decompensated cirrhosis.
12. Chronic hepatitis in patients who have been or recently (within 6 months) has been treated with immunosuppressive drugs except for corticosteroid treatment.
13. Epilepsy and / or other serious CNS disorders.

Study & Design

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