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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

- Surgically sterile

- Eastern Cooperative Oncology Group (ECOG) performance status 0-3

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 undergone surgery to prevent pregnancy or fathering children.

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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 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 am 18 years old or older.

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I have been treated with imatinib for at least three years before stopping it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

3Treatment groups

Experimental Treatment

Group I: Asciminib 80 mg daily plus dasatinib (maximum dose of 100 mg PO once daily)Experimental Treatment2 Interventions

All eligible patients will begin a combination of asciminib in combination with a TKI 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 TKI and be monitored off treatment.

Group II: Asciminib 40 mg twice daily plus nilotinib (maximum dose of 300 mg twice daily)Experimental Treatment2 Interventions

Group III: Asciminib 40 mg PO daily plus imatinib (maximum dose of 400 mg PO once daily)Experimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dasatinib

2012

Completed Phase 3

~2320

Nilotinib

2005

Completed Phase 4

~2670

Imatinib

2011

Completed Phase 3

~3940

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

610 Previous Clinical Trials

1,162,662 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: Asciminib 40 mg twice daily plus nilotinib (maximum dose of 300 mg twice daily), Asciminib 40 mg PO daily plus imatinib (maximum dose of 400 mg PO once daily), Asciminib 80 mg daily plus dasatinib (maximum dose of 100 mg PO once daily)

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

Recent research and studies

clinicaltrials.govStudy

Protocol Number: HJKC3-0003. Treatment Free Remission After Combination Therapy With Asciminib (ABL001) Plus Tyrosine Kinase Inhibitors (TKI) in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

Ehab L Atallah 2021. "Protocol Number: HJKC3-0003. Treatment Free Remission After Combination Therapy With Asciminib (ABL001) Plus Tyrosine Kinase Inhibitors (TKI) in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04838041.

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