Asciminib vs Nilotinib for Chronic Myeloid Leukemia
(ASC4START Trial)

Recruiting in Palo Alto (17 mi)

+137 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The study is designed to compare the tolerability of asciminib versus nilotinib for the treatment of newly diagnosed, previously untreated patients with Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).

Eligibility Criteria

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.

Inclusion Criteria

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.

+4 more

Exclusion 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.

+8 more

Participant Groups

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.

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

Asciminib is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Scemblix for:

Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) in adults previously treated with ≥2 tyrosine kinase inhibitors (TKIs)
Ph+ CML in CP with the T315I mutation
newly diagnosed Ph+ CML in CP

🇪🇺 Approved in European Union as Scemblix for:

Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) in adults previously treated with ≥2 tyrosine kinase inhibitors (TKIs)
Ph+ CML in CP with the T315I mutation