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Tyrosine Kinase Inhibitor

Treatment with Asciminib for Leukemia

Phase 2

Recruiting

Led By Elias Jabbour, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured

ECOG performance status ≤2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Study Summary

This trial aims to investigate if asciminib can effectively manage chronic myeloid leukemia (CML). The study will also assess the safety and potential benefits of this medication.

Who is the study for?

Adults over 18 with newly diagnosed Chronic Myeloid Leukemia in early phase (diagnosed within the last year) who have good organ function and no severe concurrent conditions. Must not be pregnant or breastfeeding, agree to use contraception, and can't have had extensive prior cancer treatments or certain heart diseases.Check my eligibility

What is being tested?

The trial is testing Asciminib's effectiveness and safety for controlling Chronic Myeloid Leukemia in its early stage. It will compare how well patients respond to this drug versus their condition without it.See study design

What are the potential side effects?

Asciminib may cause side effects such as liver issues, digestive disturbances, potential bleeding disorders, fatigue, muscle aches, and could potentially affect heart rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had hepatitis C but have been successfully treated and cured.

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I can take care of myself but might not be able to do heavy physical work.

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My liver and kidney functions are within the required limits.

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I have chronic hepatitis B but it's under control with treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety and adverse events (AEs)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment with AsciminibExperimental Treatment1 Intervention

Participants will take tablets of asciminib by mouth every day on this study. Participants should take it at least 1 hour before and 2 hours after eating. The tablets should be swallowed whole, not crushed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Asciminib

2018

Completed Phase 1

~570

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsIndustry Sponsor

2,860 Previous Clinical Trials

4,198,259 Total Patients Enrolled

151 Trials studying Leukemia

23,782 Patients Enrolled for Leukemia

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,426 Total Patients Enrolled

451 Trials studying Leukemia

31,468 Patients Enrolled for Leukemia

Elias Jabbour, MDPrincipal InvestigatorM.D. Anderson Cancer Center

13 Previous Clinical Trials

1,180 Total Patients Enrolled

13 Trials studying Leukemia

1,180 Patients Enrolled for Leukemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks and hazards associated with administering Asciminib as a therapeutic treatment for individuals?

"Based on our evaluation, Treatment with Asciminib is assigned a safety rating of 2. This determination aligns with the Phase 2 trial status, which indicates that there is limited data supporting safety but no evidence yet regarding efficacy."

Answered by AI

Are there any available slots for patients to participate in this research study?

"According to the available data on clinicaltrials.gov, this particular study is no longer actively seeking participants. The initial posting date was July 31st, 2024, and the most recent update occurred on January 24th, 2024. However, it is worth noting that there are currently a total of 1420 other studies enrolling patients at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

2024. "Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06236724.

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