drugset / Trial / NCT03874858
A Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is constituted of two stage: Treatment-Free Remission 1 (TFR1) stage and Treatment-Free Remission 2 (TFR2) stage. The purpose of the TFR1 stage is to assess the effect of nilotinib reduced to half the standard dose for 12 months on treatment-free remission in patients with Chronic Myeloid Leukemia - Chronic Phase (CML-CP) treated with first-line nilotinib who reached a sustained deep molecular response before entering the study. The purpose of the TFR2 stage is to evaluate whether the use of asciminib in combination with nilotinib after failure of a first attempt at TFR can lead to higher and more durable TFR rates after a second attempt at TKI discontinuation than those reported in other studies.
Timeline
- Start
- 2019-03-22
- Primary completion
- 2025-10-15
- Completion
- 2025-10-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Asciminib | Unknown | 40 mg | Oral |
| Subject | Nilotinib | Small molecule | 300 mg | Oral |