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Clinical Trials/2024-518216-39-00
2024-518216-39-00Not yet recruitingPhase 2

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

Region Sjaelland1 site in 1 country25 target enrollmentStarted: November 4, 2024Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Not yet recruiting
Enrollment
25
Locations
1
Primary Endpoint
Safety Profile: relevant adverse events (AE), serious AEs (SAE), withdrawal due to AEs/SAE
Study OverviewEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Safety profile of COMBI therapy in patients with polycythemia Vera after 24 months

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •The participant must meet criteria 1–3 AND at least one of 4–8
  • •Age ≥ 18 years AND
  • •A confirmed diagnosis of PV according to the WHO 2016 criteria AND
  • •A negative test for active or latent tuberculosis (from within the last month)
  • •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
  • •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
  • •Pruritus OR
  • •Symptomatic splenomegaly OR
  • •Presence of previous thrombosis

Exclusion Criteria

  • •Patients of childbearing potential without a negative pregnancy test prior to initiation of study drug. Participants must use contraceptives during the entire study period*.
  • •Other active malignancy within the past 5 years (not including non-melanoma skin cancer and prostate cancer without need for treatment).
  • •ECOG function scores> / = 3
  • •Serum creatinine more than 2 x ULN
  • •Total serum bilirubin greater than 1.5 x ULN
  • •Plasma ALAT more than 3 x ULN
  • •Former psychiatric disorder (depression diagnosed by a psychiatrist)
  • •Uncontrolled metabolic (endocrinological) disease.
  • •Severe heart disease (heart failure NYHA class 3-4).
  • •Severe myelosuppression. (WBC<1.5 Mill/L, PLA<100)
  • •Chronic hepatitis with decompensated cirrhosis.
  • •Chronic hepatitis in patients who have been or recently (within 6 months) has been treated with immunosuppressive drugs except for corticosteroid treatment.
  • •Epilepsy and / or other serious CNS disorders. *Spiral, birth control pills, implants, transdermal patch, vaginal ring or transdermal injection. Sterile / infertile subjects are exempt from the use of contraception. To be considered sterile or infertile, one must generally be surgically sterilized (vasectomy, bilateral tubectomy, hysterectomy or ovariectomy) or be postmenopausal, defined as absent menstruation for at least 12 months before study enrollment.

Outcomes

Primary Outcomes

Safety Profile: relevant adverse events (AE), serious AEs (SAE), withdrawal due to AEs/SAE

Safety Profile: relevant adverse events (AE), serious AEs (SAE), withdrawal due to AEs/SAE

Secondary Outcomes

  • 1. Safety Profile: adverse events (AE), serious AEs (SAE), withdrawal, AEs/SAEs 2. Efficacy Profile: a) Proportion of patients achieving complete hematological remission (HCT < 45, PLA ≤400 and WBC < 10) after 3, 6, 8, 9, 12, 18 and 24 months. b) Remission rates at 12 and 24 months. c) JAK2V617F allele burden measured at baseline and after 3,6,12 and 24 months. d) Proportion of patients suffering thrombosis and/or hemorrhage at 12 at 24 months. with more e)-j)

Investigators

Sponsor Class
Hospital/Clinic/Other health care facility
Responsible Party
Principal Investigator
Principal Investigator

Sponsor/PI Hans Hasselbalch

Scientific

Region Sjaelland

Study Sites (1)

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