Asciminib for Chronic Myelogenous Leukemia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Chronic Myelogenous Leukemiaasciminib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This study will be a single arm multicenter Phase II open-label, dose escalation study of asciminib in patients with CML-CP without T315I mutation who have had 1 prior TKIs for which they did not respond to treatment or were intolerant to treatment.

Eligible Conditions
  • Chronic Myelogenous Leukemia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 8 Secondary · Reporting Duration: Baseline up to 3, 6, 18, and 24 months

Month 12
Percentage of participants who achieve Major Molecular Response (MMR)
Month 24
Duration of MMR
Number of Adverse Events and Serious Adverse Events
Percentage of participants achieving Molecular Response (MR4.5)
Progression Free Survival (PFS)
Time to MMR
Time to Treatment Failure (TTF)
Month 24
Overall Survival (OS)
Month 24
MMR Rate - All scheduled time points

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

Asciminib
1 of 1

Experimental Treatment

92 Total Participants · 1 Treatment Group

Primary Treatment: Asciminib · No Placebo Group · Phase 2

Asciminib
Drug
Experimental Group · 1 Intervention: asciminib · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline up to 3, 6, 18, and 24 months

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,719 Previous Clinical Trials
3,525,162 Total Patients Enrolled
Daisy Yang, PhDStudy DirectorNovartis
Rodrigo Maegawa, MDStudy DirectorNovartis

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had at least one BCR-ABL1 positive test result at least 12 months after initiation of therapy.
You have developed a new BCR-ABL1 mutation which may cause resistance to study treatment.
>10% if 1L treatment duration between 6 and 12 months.
Patients with grade 3 or 4 toxicity (ANC or platelets) while on therapy that is recurrent after dose reduction to the lowest doses recommended by manufacturer.