All > Dasatinib

Asciminib for Chronic Myeloid Leukemia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
US Oncology P A, Tyler, TXChronic Myeloid LeukemiaAsciminib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effectiveness of asciminib versus another treatment for newly diagnosed patients with a certain type of blood cancer.

Eligible Conditions
  • Chronic Myeloid Leukemia (CML) Philadelphia Chromosome Positive

Treatment Effectiveness

Effectiveness Progress

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

Similar Trials

1
Bosutinib
1
Asciminib
1
Asciminib

Study Objectives

1 Primary · 32 Secondary · Reporting Duration: Planned total follow-up duration of 5 years

Week 48
PK of Asciminib: AUCtau and AUClast
PK of Asciminib: CL/F
PK of Asciminib: Tmax
Pharmacokinetics (PK) of Asciminib: Cmax
Trough plasma concentrations.
Week 96
Time to discontinuation of study treatment due to Adverse Events (TTDAE)
Year 5
BCR-ABL1≤1% at scheduled data collection time points
BCR-ABL1≤1% by scheduled data collection time points
Complete Hematological response (CHR) at all scheduled data collection time points
Complete Hematological response (CHR) by all scheduled data collection time points
Duration of MMR
Duration of MR4.0
Duration of MR4.5
Event Free Survival (EFS)
Failure Free Survival (FFS)
MR4.0 at scheduled data collection time points
MR4.0 by scheduled data collection time points
MR4.5 at all scheduled data collection time points
MR4.5 by all scheduled data collection time points
Major Molecular response at scheduled data collection time points
Major Molecular response by scheduled data collection time points
Overall Survival (OS)
Progression Free Survival (PFS)
Time to first MMR
Time to first MR4.0
Time to first MR4.5
Time to treatment failure (TTF)
Week 48
Major Molecular Response (MMR) at week 48
Week 96
Complete Cytogenic response (CCyR) at Week 48 & Week 96
Complete Cytogenic response (CCyR) by Week 48 & Week 96
Week 96
Major Molecular response at week 96
Week 96
Change from baseline in overall scores and individual scales of the EORTC QLQ-C30
Change from baseline in overall scores and individual scales of the EORTC QLQ-CML24

Trial Safety

Safety Progress

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

Similar Trials

1
Bosutinib
2
Asciminib
2
Asciminib

Trial Design

2 Treatment Groups

Investigator selected TKIs
1 of 2
Asciminib
1 of 2

Active Control

Experimental Treatment

402 Total Participants · 2 Treatment Groups

Primary Treatment: Asciminib · No Placebo Group · Phase 3

Asciminib
Drug
Experimental Group · 1 Intervention: Asciminib · Intervention Types: Drug
Investigator selected TKIsActiveComparator Group · 4 Interventions: Bosutinib, Nilotinib, Imatinib, Dasatinib · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Asciminib
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: planned total follow-up duration of 5 years

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,736 Previous Clinical Trials
3,543,912 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Has the FDA sanctioned Asciminib for public use?

"Asciminib falls into our "safe" category, with a 3/3 score. This is because it's a Phase 3 trial, meaning that there is not just some data supporting efficacy, but multiple rounds of data confirming its safety." - Anonymous Online Contributor

Unverified Answer

What has been the medical community's response to Asciminib thus far?

"Presently, there are one-hundred and forty different studies investigating Asciminib with twenty-nine in Phase 3. Many of the tests for this medication are taking place in Montreal, Quebec; however, 5884 other areas around the world are also running similar research." - Anonymous Online Contributor

Unverified Answer

What has Asciminib been shown to be an effective treatment for?

"Refractory [acute lymphoblastic leukemia](https://www.withpower.com/clinical-trials/acute-lymphoblastic-leukemia) (ALL) is most commonly treated with the medication asciminib. This drug is also used to manage other conditions, such as chordomas, blast phase, and refractory chronic phase chronic myeloid leukemia." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top