← Back to Search

Tyrosine Kinase Inhibitor

Asciminib for Pediatric Chronic Myeloid Leukemia

Phase 1 & 2
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female participants in the Pediatric formulation group must be ≥ 1 and less than 18 years of age at study entry. Male or female participants in the Adult formulation group must be ≥ 14 and less than 18 years of age with a body weight of ≥ 40 kg at study entry
Participants with Ph+ CML-CP must meet specific laboratory values at the screening visit including percentages of blasts, promyelocytes, basophils, neutrophils, platelet count, absence of extramedullary leukemic involvement, prior treatment with a minimum of one TKI, failure or intolerance to the most recent TKI therapy, specific performance status, adequate renal, hepatic, pancreatic, and cardiac function, electrolyte values within normal limits, and evidence of typical BCR-ABL1 transcript [e14a2 and/or e13a2] at the time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after first dose at week 1 day 1, 4 weeks, 52 weeks
Awards & highlights

Study Summary

This trial is testing a new cancer drug in children. The goal is to see if it works better than other drugs already being used to treat kids with cancer.

Who is the study for?
This trial is for pediatric patients aged 1 to <18 years with chronic myeloid leukemia who have been treated with at least one TKI. They must not be pregnant, have a history of severe liver disease or pancreatitis, and cannot plan for a stem cell transplant. Eligible participants should have stable blood counts and organ functions.Check my eligibility
What is being tested?
The study tests two formulations of asciminib (pediatric and adult) in young patients previously treated with tyrosine kinase inhibitors (TKIs). It aims to establish the appropriate dose for children while assessing safety by comparing responses between age groups.See study design
What are the potential side effects?
Potential side effects are not specified but may include those common to cancer treatments such as nausea, fatigue, changes in blood counts leading to increased infection risk, liver issues, and potential heart problems.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after first dose at week 1 day 1, 4 weeks, 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and after first dose at week 1 day 1, 4 weeks, 52 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
Primary PK parameter: AUCtau
Primary Pharmacokinetic (PK) parameter: AUClast
Secondary PK parameter: Cmax
+2 more
Secondary outcome measures
Hematologic responses
Molecular responses
Questionnaire on acceptability and palatability after first dose, 4 and 52 weeks

Trial Design

1Treatment groups
Experimental Treatment
Group I: AsciminibExperimental Treatment2 Interventions
This arm consists of 2 groups: The pediatric formulation group where the dose is based on body weight (1.3mg/kg) The adult formulation group where participants will receive a flat dose of 40mg BID

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,324 Total Patients Enrolled

Media Library

Asciminib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04925479 — Phase 1 & 2
Myeloid Leukemia Research Study Groups: Asciminib
Myeloid Leukemia Clinical Trial 2023: Asciminib Highlights & Side Effects. Trial Name: NCT04925479 — Phase 1 & 2
Asciminib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04925479 — Phase 1 & 2

Frequently Asked Questions

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

Are adults of age eligible for this test?

"The least amount of time that a patient has to have lived is 1 year, and the maximum age requirement for this study is 18 years old."

Answered by AI

What other medical studies have there been on children's reactions to Asciminib?

"Asciminib Pediatric formulation group is being studied in 486 locations across the globe, with the majority of research taking place in New South Wales. Of the 15 total trials, 4 are currently in Phase 3."

Answered by AI

Do you have any information about whether this clinical trial is still enrolling patients?

"Yes, this study is currently recruiting patients. According to the clinicaltrials.gov website, the trial was originally posted on December 27th, 2021 and was last edited on October 14th, 2022."

Answered by AI

How many volunteers are being sought for this experiment?

"That is accurate, the clinical trial in question is detailed on clinicaltrials.gov and it is currently looking for 34 individuals to participate across 2 sites. The study was originally posted on December 27th, 2021 and was last updated on October 14th, 2022."

Answered by AI

May I enroll myself in this research project?

"This clinical trial is enrolling 34 participants with myeloid leukemia between the ages of 1 Year and 18. Most importantly, applicants must meet the following criteria: - Participants with Ph+ CML-CP must meet all of the following laboratory values at the screening visit. In the case where bone marrow blast and promyelocyte counts are available, these will be accepted if done within 56 days prior to the screening visit, to avoid unnecessary repetition of this test., - < 15% blasts in peripheral blood and bone marrow, - < 30% combined blasts plus promyelocytes in peripheral blood and"

Answered by AI

Is this a new or innovative study?

"Research into Asciminib Pediatric formulation group began in 2014 with a study that was sponsored by Novartis Pharmaceuticals. The first Phase 1 clinical trial included 326 patients and after its completion, the drug received approval. Today, 15 different trials are ongoing across 45 countries and 146 cities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia
2021. "Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04925479.
~17 spots leftby Sep 2026
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