A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms

• Status: Unknown status
• Trial end date: 2020-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare the efficacy and toxicity including quality of life of two types of low-dose interferon alpha compounds (PegIntron and Pegasys) with hydroxyurea (Hydrea), and to investigate the occurence of neutralizing antibodies against recombinant interferon.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Stauffer Larsen
• Treatments: Hydroxyurea; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Peginterferon alfa-2b

Criteria

Inclusion Criteria:

• Male or female > 18 years of age

• Newly diagnosed, or previously diagnosed untreated patients with ET, PV or PMF including prefibrotic myelofibrosis according to the WHO classification

• Active disease defined by one of the following criteria:

• need for phlebotomy

• leukocytosis > 10 mia/l

• thrombocytosis > 400 mia/l

• constitutional symptoms (fatigue, weight loss, night sweats or fewer > 38 degrees celsius)

• Pruritus

• splenomegaly causing symptoms

• previous thrombosis

Exclusion Criteria:

• Fertile women without a negative pregnancy test

• Other malignant disease within last 5 years

• ECOG performance score >/= 3

• Creatinine > 2x ULN

• Bilirubin > 1.5x ULN

• ALAT > 3x ULN

• Previous psychiatric disorder (depression)

• active autoimmune disease

• Uncontrolled thyroid disease