Asciminib for Chronic Myeloid Leukemia
(ASC2ESCALATE Trial)

Recruiting in Palo Alto (17 mi)

+108 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP- binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.

Research Team

Novartis

Principal Investigator

Novartis

Eligibility Criteria

This trial is for adults with chronic myeloid leukemia who have either failed or couldn't tolerate their first treatment, or are newly diagnosed and treated briefly. They should be in good physical condition, not in the advanced stages of leukemia, and without serious heart issues or a history of certain other cancers.

Inclusion Criteria

I experienced severe side effects from my cancer treatment that didn't improve with changes.

I've had severe blood-related side effects from treatment, even after the dose was lowered.

My BCR-ABL1 levels are above 10% after 6-12 months of first-line treatment.

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Exclusion Criteria

I have received previous treatment.

I do not have Long QT syndrome or a family history of sudden death.

I am not taking any strong drugs that affect liver enzymes with my 200 mg twice daily medication.

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Treatment Details

Interventions

Asciminib (Tyrosine Kinase Inhibitor)

Trial OverviewAsciminib (Scemblix) is being tested as a solo treatment for chronic myeloid leukemia. The study will include patients previously treated with one TKI drug that didn't work well or caused side effects, as well as new patients who've had minimal prior treatment.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: AsciminibExperimental Treatment1 Intervention

80 mg initial oral dose taken once a day with possible dose escalation