drugset / Trial / NCT03831776
Long-acting Low Dose Ropeginterferon for Chronic Myeloid Leukemia Treated With Bosutinib From Diagnosis
Phase 2
Completed
212 enrolled
St. Olavs Hospital
Haukeland University Hospital · collabHelse Stavanger HF · collabHenri Mondor University Hospital · collabHôpital Mignot, Versailles Paris · collabHôpital René Huguenin · collabOdense University Hospital · collabOslo University Hospital · collabUniversity Hospital of North Norway · collabUppsala University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
To study the efficacy and safety of combination of Ro-Peg-interferon-α2b (RoPegIFN) with Bosutinib (BOS) in comparison to BOS monotherapy, as frontline therapy for newly diagnosed chronic myeloid leukemia patients, and to estimate efficacy of the addition of RoPegIFN to BOS in terms of deep molecular response with the aim of increasing the proportion of patients who may achieve treatment free remission. (NCMLSG study #NordCML012)
Timeline
- Start
- 2019-03-25
- Primary completion
- 2024-12-31
- Completion
- 2024-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bosutinib | Small molecule | 400 mg | — |
| Subject | Ro-Peg-Interferon α2b | Unknown | 50 ug | Subcutaneous |