trialsTrialActive

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

A phase 3 trial of Asciminib and Nilotinib in chronic myeloid leukaemia, run by Novartis Pharmaceuticals, active and no longer recruiting.

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) is a phase 3 interventional study registered as NCT05456191 by Novartis Pharmaceuticals, with 568 participants enrolled, started 2022-11-21 and due to reach its primary completion in 2025-05-15. Interventions recorded: Asciminib and Nilotinib. Results have been posted on the registry.

Setting

A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase.

Phase

Phase 3

Sponsor

Novartis Pharmaceuticals

Registry

Started

2022-11-21

Reported

2026

Enrolled

568 enrolled

Outcomes

In plain words

What these results mean for people, not percentages

568 enrolled

Time to Discontinuation of Study Treatment Due to Adverse Event (TTDAE) (From Interim Analysis)primaryother endpoint

Asciminib: 16 participants; Nilotinib: 34 participants.
Put another way, the treated group had about 55 percent lower chance of the event at any given time (hazard ratio 0.45, likely range 0.25 to 0.81).

This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
These results apply to the people the trial enrolled: A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

568 enrolled.

Time to Discontinuation of Study Treatment Due to Adverse Event (TTDAE) (From Interim Analysis)primary

HR 0.45 (0.25 to 0.81) · p = 0.004

Download

Figures from the ClinicalTrials.gov results section (first posted 2026-05-27), not from a publication

Endpoint	Arm	n	Value	HR (95% CI)	p	Source
Time to Discontinuation of Study Treatment Due to Adverse Event (TTDAE) (From Interim Analysis)primary	Asciminib	284	16 participants	0.45 (0.25 to 0.81)	0.004	link
	Nilotinib	282	34 participants	0.45 (0.25 to 0.81)	0.004	link

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cancers

Chronic myeloid leukaemia (CML)Chronic myeloid leukaemia, chronic phase

technologies

Small-molecule kinase inhibitors

drugs

ApprovedSmall-molecule allosteric ABL1 inhibitor (STAMP)

Asciminib · Scemblix

ApprovedSmall-molecule BCR-ABL1 TKI (second generation)

Nilotinib · Tasigna

companies

Advanced Accelerator Applications (Novartis)Novartis