Your session is about to expire
← Back to Search
Tyrosine Kinase Inhibitor
Asciminib vs Nilotinib for Chronic Myeloid Leukemia (ASC4START Trial)
Phase 3
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, every 4 weeks from week 4 to week 12, after week 24, week 48, week 96, eot and every 4 weeks until 12 weeks after eot, assessed up to approximately 4,5 years.
Awards & highlights
ASC4START Trial Summary
This trial will compare two drugs to treat newly diagnosed Chronic Myelogenous Leukemia in Chronic Phase.
Who is the study for?
Adults (≥18 years) newly diagnosed with Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in chronic phase can join. They must be within 3 months of diagnosis, have an ECOG performance status of 0 or 1, and proper organ function. Excluded are those previously treated for CML (except hydroxyurea/anagrelide), with certain heart conditions, severe concurrent diseases, recent major surgery, other active malignancies within the past 3 years (some exceptions apply), a history of pancreatitis or liver disease, and known HIV/HBV/HCV infections.Check my eligibility
What is being tested?
The trial is testing the tolerability and effectiveness of two oral drugs: Asciminib versus Nilotinib in adults with newly diagnosed Ph+ CML-CP. Participants will receive one drug or the other to compare how well they tolerate them and how effective they are at treating their leukemia.See study design
What are the potential side effects?
Potential side effects for both Asciminib and Nilotinib include nausea, rash, fatigue, headaches, muscle pain; however specific side effects may vary between drugs. Heart problems like abnormal heartbeat could occur especially if there's a history of cardiac issues.
ASC4START Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, every 4 weeks from week 4 to week 12, after week 24, week 48, week 96, eot and every 4 weeks until 12 weeks after eot, assessed up to approximately 4.5 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, every 4 weeks from week 4 to week 12, after week 24, week 48, week 96, eot and every 4 weeks until 12 weeks after eot, assessed up to approximately 4.5 years.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to discontinuation of study treatment due to adverse event (TTDAE).
Secondary outcome measures
Malignant Neoplasms
Malignant Neoplasms
Duration of MMR
+19 moreASC4START Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AsciminibExperimental Treatment1 Intervention
Participants will receive asciminib 80 mg QD
Group II: NilotinibActive Control1 Intervention
Participants will receive nilotinib 300 mg BID
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Asciminib
FDA approved
Find a Location
Who is running the clinical trial?
Novartis PharmaceuticalsLead Sponsor
2,860 Previous Clinical Trials
4,197,759 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have only been treated with hydroxyurea or anagrelide for my CML.I have a severe illness that is not under control.I have had pancreatitis before.I have HIV but it is well-controlled with medication.I haven't had any other cancer besides this one in the last 3 years.My leukemia is in the chronic phase and has been confirmed to have the Philadelphia chromosome.My chronic myeloid leukemia matches specific criteria set in 2013.I am fully active or can carry out light work.I have not had major surgery in the last 4 weeks.I have a history of chronic Hepatitis B or C.I was diagnosed with chronic myeloid leukemia in the chronic phase less than 3 months ago.My organs are functioning well.I have a history of serious bleeding problems.I have a heart condition affecting its function or electrical activity.My kidney function is slightly impaired, but my lab values are normal or corrected.I have a history of liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Nilotinib
- Group 2: Asciminib
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any evidence to suggest Asciminib is not safe for human consumption?
"After careful consideration, our team at Power has assigned Asciminib a score of 3 given the prior clinical data suggesting its safety and efficacy. This is due to it being in Phase 3 of the trial process."
Answered by AI
How many centers are actively coordinating this research study?
"Currently, 80 different clinical sites are enrolling patients into this study. These locations span from Lille Cedex to Lyon and Dresden, as well as a multitude of other cities across the continent. It is imperative that participants pick the closest research centre in order to limit travel requirements for their participation."
Answered by AI
To what extent is this research project being populated by volunteers?
"Yes, the information on clinicaltrials.gov confirms that this medical investigation is currently seeking participants. The trial was initially listed on November 21st 2022 and has most recently been updated on June 8th 2023; 541 patients are being sought out from 80 different sites across the country."
Answered by AI
Has enrollment been opened for this medical experiment yet?
"According to clinicaltrials.gov, this trial has resumed recruitment and is now seeking participants since its initial posting on November 21st 2022 with the most recent update being made on June 8th 2023."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger