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Tyrosine Kinase Inhibitor

Asciminib Combinations for Chronic Myeloid Leukemia (ALERTCML Trial)

Phase 2
Recruiting
Led By Jorge Cortes, MD
Research Sponsored by Augusta University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate organ function: AST and ALT < 3 times the institutional upper limit of normal (ULN), Creatinine < 1.5 times the institutional upper limit of normal, Total bilirubin < 1.5 times the institutional ULN or < 3.0 x the institutional ULN with Gilbert Syndrome (unless direct bilirubin is within normal limits), Adequately controlled blood pressure, defined as systolic blood pressure of <140 mmHq and diastolic of <90 mmHg, at the time of enrollment, Serum lipase less than or equal to 1.5 x ULN. For serum lipase > ULN - less than or equal to 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis.
Age ≥18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

ALERTCML Trial Summary

This trial is testing a new leukemia drug, and whether adding another drug may help patients who don't respond well to the first drug.

Who is the study for?
Adults over 18 with newly diagnosed Chronic Myeloid Leukemia in chronic phase, who have not been treated for more than 30 days. They must have normal organ function and agree to effective contraception. Excluded are those with advanced CML stages, other active cancers, recent pancreatitis, certain blood disorders or taking strong CYP3A4 inhibitors/inducers.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of asciminib as an initial oral treatment for new Chronic Myeloid Leukemia patients. If no response after up to 36 months, a low dose of dasatinib, imatinib or nilotinib may be added at the doctor's choice.See study design
What are the potential side effects?
Possible side effects include digestive issues (like pancreatitis), changes in blood counts leading to increased infection risk or bleeding problems, liver enzyme alterations and potential interactions with other drugs metabolized by specific liver enzymes.

ALERTCML Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I can take care of myself and perform daily activities.

ALERTCML Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure 1: Deep Molecular Response

ALERTCML Trial Design

1Treatment groups
Experimental Treatment
Group I: AsciminibExperimental Treatment4 Interventions
Asciminib 80mg taken orally once a day starting cycle 1 day 1 for up to 24 months during the single agent asciminib phase. Patients who have not achieved MR4.5 after 24 months will be given a low dose tyrosine kinase inhibitor (low-TKI). There will be three options of low-TKIs to be given at the investigator's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Asciminib
2018
Completed Phase 1
~570

Find a Location

Who is running the clinical trial?

Augusta UniversityLead Sponsor
210 Previous Clinical Trials
85,020 Total Patients Enrolled
H. Jean Khoury Cure CML ConsortiumOTHER
2 Previous Clinical Trials
102 Total Patients Enrolled
Jorge Cortes, MDPrincipal InvestigatorAugusta University
31 Previous Clinical Trials
1,476 Total Patients Enrolled

Media Library

Asciminib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05143840 — Phase 2
Myeloid Leukemia Research Study Groups: Asciminib
Myeloid Leukemia Clinical Trial 2023: Asciminib Highlights & Side Effects. Trial Name: NCT05143840 — Phase 2
Asciminib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05143840 — Phase 2

Frequently Asked Questions

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

Are there any US-based medical facilities implementing this investigation?

"This research project is recruiting participants at several different medical establishments, such as the Roswell Park Comprehensive Cancer Center in Buffalo, the Froedtert Hospital & The Medical College of Wisconsin in Milwaukee, and Georgia Cancer Center at Augusta University in Augusta."

Answered by AI

Has Asciminib received the necessary authorization from the FDA?

"The safety of Asciminib was evaluated as a 2, since it falls under Phase 2 clinical trials and has yet to demonstrate efficacy in humans."

Answered by AI

What is the aggregate of individuals taking part in this experiment?

"This clinical trial requires a total of 8 participants that match the predetermined eligibility criteria. These individuals can join this medical study at sites like Roswell Park Comprehensive Cancer Center in Buffalo, New york and Froedtert Hospital & the Medical College of Wisconsin located in Milwaukee, Georgia."

Answered by AI

Has this trial ever been conducted prior to its current iteration?

"As of today, 44 clinical trials are underway to evaluate the efficacy of asciminib. These research projects span 587 cities and 47 nations. Novartis Pharmaceuticals conducted the initial trial in 2008 with 34 participants; since then, 82 experiments have been concluded successfully."

Answered by AI

What prior inquiries have been conducted regarding Asciminib?

"Novartis Investigative Site first initiated research on asciminib in 2008 and has since completed 82 studies. There are 44 ongoing trials, with a substantial amount located in Buffalo, New york."

Answered by AI

Are there any openings for volunteers in this experiment?

"Affirmative. Clinicaltrials.gov hosts information which affirms that this clinical trial, first posted on April 22nd 2022, is actively enrolling subjects. Notably, 8 patients need to be recruited from 4 separate medical centres."

Answered by AI
~2 spots leftby Feb 2025