A Study of Full Treatment-free Remission in Patients With Chronic Myeloid Leukemia

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

Outcome

Outcome not reported

Stopped (Business): “Sponsor decision: The primary endpoint of the core/TF1 was achieved, and the sample size of Extension/TFR2 was unlikely to yield meaningful results. No new safety signals were observed. For these reasons, continuing the study was not justified.”

Drugs

Indications