Clinical trial · Interventional
A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms
Danish Study of Low-dose Interferon Alpha Versus Hydroxyurea in the Treatment of Philadelphia Chromosome Negative (Ph-)Chronic Myeloid Neoplasms.
NCT01387763CI-TRIAL-00058083DALIAHcompletedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Essential Thrombocythemia | Essential Thrombocythemia | ONTOLOGY_EXACT | 0.98 |
| Polycythemia Vera | Polycythemia Vera | ONTOLOGY_EXACT | 0.98 |
| Primary Myelofibrosis | Primary Myelofibrosis | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hydrea | Drug | Hydroxyurea | ALIAS |
| Pegasys | Drug | Peginterferon Alfa-2a | ALIAS |
| PegIntron | Drug | Peginterferon Alfa-2b | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- PegIntron <= 60 years
- description
- In patients \<= 60 years PegIntron is started at low-dose 35 micrograms once weekly. Dose escalation to 50 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 50 micrograms weekly at 12 months and 18 months respectively, dose escalation to 96 micrograms weekly.
- interventionNames
- Drug: PegIntron
- type
- ACTIVE_COMPARATOR
- label
- Pegasys <= 60 years
- description
- In patients \<= 60 years Pegasys is started at low-dose 45 micrograms once weekly. Dose escalation to 90 micrograms weekly if lack of complete hematological response at 4 months or lack of at least partial molecular response at 8 months. If complete hematological response or lack of at least partial molecular response is not achieved at 90 micrograms weekly at 12 months and 18 months respectively, dose escalation to 135 micrograms weekly.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBistrup CN, Larsen MK, Junker P, Skov V, Kjaer L, Knudsen TA, Karsdal M, Willumsen N, Hasselbalch HC. Collagen Turnover Is Associated with Disease Severity, Bone Marrow Fibrosis, and the JAK2V617F Variant Allele Frequency in Myeloproliferative Neoplasms. Cancers (Basel). 2026 Aug 6;18(15):2529. doi: 10.3390/cancers18152529. PMID 42588744