Asciminib 40 mg BID single agent group for Chronic Myelogenous Leukemia (CML)

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Chronic Myelogenous Leukemia (CML)+2 MoreECG - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment

Eligible Conditions
  • Chronic Myelogenous Leukemia (CML)
  • Leukemia
  • Acute Lymphoblastic Leukemia

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 5 years

5 years
Number of participabts with adverse events (AEs) and serious adverse events (SAEs)
Percentage of participants with clinical benefit as assessed by Investigator

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

8 Treatment Groups

Asciminib 40 mg BID single agent group
1 of 8
Bosutinib-asciminib switch group
1 of 8
Asciminib in combination with dasatinib group
1 of 8
Asciminib 60 mg QD combined with imatinib group
1 of 8
Asciminib 40 mg QD combined with imatinib group
1 of 8
Asciminib in combination with imatinib group
1 of 8
Asciminib in combination with nilotinib group
1 of 8
Asciminib single agent group
1 of 8

Experimental Treatment

347 Total Participants · 8 Treatment Groups

Primary Treatment: Asciminib 40 mg BID single agent group · No Placebo Group · Phase 4

Asciminib 40 mg BID single agent groupExperimental Group · 2 Interventions: Pregnancy test, Asciminib single agent · Intervention Types: Procedure, Drug
Bosutinib-asciminib switch groupExperimental Group · 3 Interventions: ECG, Pregnancy test, Asciminib single agent · Intervention Types: Procedure, Procedure, Drug
Asciminib in combination with dasatinib group
Drug
Experimental Group · 1 Intervention: Dasatinib · Intervention Types: Drug
Asciminib 60 mg QD combined with imatinib groupExperimental Group · 3 Interventions: Pregnancy test, Asciminib, Imatinib · Intervention Types: Procedure, Drug, Drug
Asciminib 40 mg QD combined with imatinib groupExperimental Group · 3 Interventions: Pregnancy test, Asciminib, Imatinib · Intervention Types: Procedure, Drug, Drug
Asciminib in combination with imatinib groupExperimental Group · 2 Interventions: Asciminib, Imatinib · Intervention Types: Drug, Drug
Asciminib in combination with nilotinib groupExperimental Group · 2 Interventions: Asciminib, Imatinib · Intervention Types: Drug, Drug
Asciminib single agent group
Drug
Experimental Group · 1 Intervention: Asciminib single agent · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ECG
2016
Completed Phase 4
~33530
Pregnancy test
2017
N/A
~530
Asciminib
FDA approved
Imatinib
FDA approved
Dasatinib
2012
Completed Phase 2
~1890

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,717 Previous Clinical Trials
3,524,508 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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