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Tyrosine Kinase Inhibitor

Asciminib for Chronic Myelogenous Leukemia

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At any time after the initiation of therapy BCR-ABL1 >1% IS, emergence of resistance mutations, high-risk ACA
In addition, patients with failure of treatment according to the ELN 2020 recommendations will be eligible:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4, 12, 24, 48, 72, 96, 120 and at end of treatment (up to 144 weeks).
Awards & highlights

Study Summary

This trial will study the effectiveness of asciminib in patients with CML who have already been treated with two other TKIs.

Who is the study for?
This trial is for adults with chronic myelogenous leukemia in chronic phase (CML-CP) who have tried at least two Tyrosine Kinase Inhibitors without success or cannot tolerate them. They must not have had a stem-cell transplant, plan to undergo one soon, or have certain heart conditions or severe medical issues.Check my eligibility
What is being tested?
The study aims to find the best dose of asciminib for treating CML-CP after failure with other treatments. Patients will take either 40 mg twice daily or 80 mg once daily of asciminib and their response will be monitored according to specific criteria.See study design
What are the potential side effects?
Asciminib may cause side effects such as low blood cell counts leading to increased infection risk, bleeding problems, fatigue, liver issues, and possibly pancreatitis. Heart rhythm problems are also a concern.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has shown resistance or high-risk changes after starting treatment.
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My treatment failed according to the 2020 ELN guidelines.
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I've had severe blood-related side effects from treatment, even after the dose was lowered.
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I am 18 or older with chronic myeloid leukemia in the chronic phase.
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My cancer markers increased after starting treatment.
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I have been treated with at least 2 types of TKI medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4, 12, 24, 48, 72, 96, 120 and at end of treatment (up to 144 weeks).
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4, 12, 24, 48, 72, 96, 120 and at end of treatment (up to 144 weeks). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major molecular response (MMR) rate at Week 48 for all patients with no evidence of MMR at baseline.
Secondary outcome measures
Change in symptom burden and interference from baseline over time according to the MDASI-CML PRO instrument.
Cumulative molecular response rate of BCR-ABL1 ≤ 10%.
Cumulative molecular response rate of BCR-ABL1 ≤1%.
+17 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: ABL001Experimental Treatment3 Interventions
Participants will be treated with 80 mg of ABL001 (40 mg BID or 80mg QD). In patients not achieving MMR at 48 weeks or losing the response after the week 48 assessment up to week 108, asciminib dose may be escalated to 200 mg q.d. if in the investigator's opinion the patient may benefit from the escalation.

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,197,151 Total Patients Enrolled
151 Trials studying Leukemia
23,633 Patients Enrolled for Leukemia

Media Library

Asciminib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04948333 — Phase 3
Leukemia Research Study Groups: ABL001
Leukemia Clinical Trial 2023: Asciminib Highlights & Side Effects. Trial Name: NCT04948333 — Phase 3
Asciminib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04948333 — Phase 3

Frequently Asked Questions

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

Are there other ABL001 clinical trials that have used a 80mg once-daily dosage?

"There are 15 ongoing clinical trials researching ABL001 80mg QD. Of these, 4 are in Phase 3. The majority of the trial locations for this medication are in Houston, Texas; however, there are 486 total facilities running studies on ABL001 80mg QD."

Answered by AI

How can I sign up to help with this research?

"Patients with leukemia, myeloid and between the ages of 18 and 99 may be eligible for this clinical trial. A total of 195 individuals are being sought out by researchers."

Answered by AI

Has ABL001 80mg QD received FDA approval?

"ABL001 80mg QD receives a 3 for safety from our Power team. This is due to the fact that it is a Phase 3 trial, signifying that while there is data affirming efficacy, there are also multiple rounds of data confirming safety."

Answered by AI

Does this research project allow elderly individuals to participate?

"This clinical trial is seeking patients that fall between the ages of 18 to 99. There are other 448 trials for people under the age of majority and 1216 for seniors."

Answered by AI

How many individuals are currently enrolled in this experiment?

"Yes, this is an ongoing clinical trial that has been actively recruiting since October 13th 2021. The study's purpose is to find 195 participants at 2 different locations."

Answered by AI

Is this research leading the field in new discoveries?

"ABL001 80mg QD has been under investigation since 2014. The first trial, sponsored by Novartis Pharmaceuticals, took place that year and included 326 patients. After the initial study in 2014 showed promising results, ABL001 80mg QD received Phase 1 drug approval. Currently, there are 15 active trials for ABL001 80mg QD being conducted across 45 different countries and 146 cities."

Answered by AI

Are we still enrolling people in this research project?

"This clinical trial is still actively looking for participants, according to the latest update on clinicaltrials.gov from November 10th, 2022. The original posting date was October 13th, 2021."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Asciminib Treatment Optimization in ≥ 3rd Line CML-CP.
2021. "Asciminib Treatment Optimization in ≥ 3rd Line CML-CP.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04948333.
~12 spots leftby Jun 2024
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