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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

Must not have

- ECOG 0-3

- Completion of 12 cycles on the combination therapy phase

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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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 completed 12 cycles of combination therapy.

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I have had a stem cell transplant from a donor.

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My leukemia has entered an advanced stage.

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I have had pancreatitis in the last year.

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I am currently being treated for another cancer.

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I have been treated with asciminib before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

One-year "second" treatment-free remission.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Nilotinib

2005

Completed Phase 4

~2670

Dasatinib

2012