drugset / Trial / NCT01933906
Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response
Phase 1
Completed
12 enrolled
Study Group of Medical Tumour Therapy (AGMT)
AOP Orphan Pharmaceuticals AG · collab
NaSingle-groupOpen-labelTreatment
Summary
In this phase I pilot study, it is planned to investigate the feasibility and safety of adding an interferon therapy to an preexisting imatinib treatment in patients with chronic phase chronic myeloid leukaemia. The participating patients have already reached a response during their imatinib therapy (CCyR) but have still a detectable disease (no molecular response MR 4.5 or better).
Timeline
- Start
- 2013-08-30
- Primary completion
- 2018-11-14
- Completion
- 2018-11-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ropeginterferon alfa-2b | Protein / enzyme biologic | 100 ug | Subcutaneous |