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Tyrosine Kinase Inhibitor

Asciminib + Imatinib for Chronic Myeloid Leukemia

Phase 2
Recruiting
Led By Ehab Atallah, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with CML in chronic phase and have either the b3a2 (e14a2) or b2a2 (e13a2) variants that give rise to the p210 BCR-ABL protein. Subtype classification whether b3a2 (e14a2) or b2a2 (e13a2) is not required for study eligibility
- Surgically sterile
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial will study the effects of a new drug on patients with chronic myeloid leukemia who have attempted to discontinue imatinib.

Who is the study for?
Adults diagnosed with chronic phase chronic myeloid leukemia (CP-CML) who have tried to stop taking imatinib once before but relapsed. They must be on imatinib again, agree to use two contraception methods if of childbearing potential, and meet specific health criteria including a stable molecular response for over two years and an ECOG performance status of 0-3.Check my eligibility
What is being tested?
The trial is testing the combination therapy of Asciminib plus Imatinib in patients with CP-CML who previously relapsed after stopping treatment. It's a single-arm phase II study aiming for 41-51 participants to see if this combo can allow them to achieve treatment-free remission.See study design
What are the potential side effects?
Potential side effects may include liver issues indicated by increased bilirubin levels, pancreatitis, changes in blood cell counts leading to higher infection risk or bleeding problems, heart rhythm abnormalities seen on an ECG, and possibly other organ function alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chronic phase CML with a specific protein variant.
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I have undergone surgery to prevent pregnancy or fathering children.
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My test results show a stable low level of cancer for over 2 years.
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I can care for myself but may not be able to do heavy physical work.
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I have been retaking imatinib for at least a year after my first treatment failed and plan to continue it.
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I am a male and agree to follow the birth control requirements.
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I have tried stopping imatinib once before with my doctor's advice.
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My cancer returned after stopping imatinib with a specific test result.
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I have been postmenopausal for at least one year.
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I am 18 years old or older.
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I agree to practice true abstinence as a form of contraception.
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I am a woman who is not pregnant, not breastfeeding, and not able to become pregnant.
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I agree to practice true abstinence as a form of contraception.
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I have been treated with imatinib for at least three years before stopping it.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
One-year "second" treatment-free remission.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Combination Therapy and Remission PhaseExperimental Treatment2 Interventions
All eligible patients will begin a combination of asciminib plus imatinib cycle 1 day 1 in the combination treatment phase. They will continue combination therapy for a total of 12 cycles (minimum of 12 months). At the end of 12 cycles asciminib will be discontinued and any patient who has met the criteria for the treatment free remission (TFR) screening phase will enter into the TFR phase. Once in the TFR phase, patients will discontinue their imatinib and be monitored off treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Asciminib
2018
Completed Phase 1
~20
Imatinib
2011
Completed Phase 3
~3940

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
608 Previous Clinical Trials
1,162,460 Total Patients Enrolled
H. Jean Khoury Cure CML ConsortiumOTHER
2 Previous Clinical Trials
59 Total Patients Enrolled
Ehab Atallah, MDPrincipal InvestigatorMedical College of Wisconsin
9 Previous Clinical Trials
667 Total Patients Enrolled

Media Library

Asciminib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04838041 — Phase 2
Chronic Myelogenous Leukemia Research Study Groups: Combination Therapy and Remission Phase
Chronic Myelogenous Leukemia Clinical Trial 2023: Asciminib Highlights & Side Effects. Trial Name: NCT04838041 — Phase 2
Asciminib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04838041 — Phase 2

Frequently Asked Questions

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

Is this research still looking for participants?

"The study, which was most recently updated on May 3rd, 2022, is still recruiting patients as noted on clinicaltrials.gov. This information was originally posted on November 11th, 2021."

Answered by AI

How many people are being given the chance to participate in this clinical trial?

"That is correct, the online clinicaltrials.gov database shows that this study is open for recruitment. This particular trial was posted on November 11th, 2021 and was edited most recently on May 3rd, 2022. The research team plans to enroll 51 individuals from 2 different locations."

Answered by AI

What is the usual purpose of taking Asciminib?

"Asciminib is used to treat several conditions, including newly diagnosed acute lymphoblastic leukaemia, refractory acute lymphoblastic leukemia (all), metastatic dermatofibrosarcoma protuberans."

Answered by AI

Has the FDA cleared Asciminib for use?

"While there is some evidence to support the safety of Asciminib, it only received a score of 2 because this medication has not been proven effective yet in clinical trials."

Answered by AI

Are there other scientific papers which feature Asciminib?

"At the moment, there are 65 different clinical trials testing Asciminib. Out of those, 19 are in Phase 3. Most of these studies are located in Adelaide, South Australia; however, 2050 research centres around the world are runningasciminib trials."

Answered by AI
~33 spots leftby Jun 2028