drugset / Trial / NCT04838041
Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation
Phase 2
Recruiting
51 enrolled
Medical College of Wisconsin
H. Jean Khoury Cure CML Consortium · collab
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.
Timeline
- Start
- 2021-11-11
- Primary completion
- 2028-06
- Completion
- 2029-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asciminib | Unknown | 40 mg | Oral |
| Subject | Asciminib | Unknown | 80 mg | Oral |
| Background | Imatinib | Small molecule | 400 mg | Oral |
| Background | Nilotinib | Small molecule | 300 mg | — |
| Background | dasatinib anhydrous | Small molecule | 100 mg | Oral |