NCT04838041

Protocol Number: HJKC3-0003. Treatment Free Remission After Asciminib Based Therapy in Chronic Phase Chronic Myeloid Leukemia (CP-CML) Patients Who Relapsed After a Prior Attempt at TKI Discontinuation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single arm phase II study that will enroll a minimum of 47 subjects with a maximum of 51. All patients will have a confirmed diagnosis of chronic phase chronic myeloid Leukemia and must have previously attempted to discontinue Tyrosine Kinase inhibitors (TKI). All patients must have restarted the same TKI they were on prior to discontinuation at the time of relapse in order to be eligible for this trial.

Detailed description

All eligible patients will begin asciminib plus/minus TKI on cycle 1 day 1 of the consolidation phase. They will continue therapy for a total of 12 cycles (minimum of 12 months). Each cycle will be \~28 days. At the end of 12 cycles, asciminib plus/minus TKI will be discontinued in patients who continue to satisfy the requirements for TFR attempt. The primary endpoint of this study is the 12-month 'second' TFR rate after completion of 12 cycles of asciminib based therapy. Patients will remain in the TFR phase of the study for up to three years and will have central PCR testing during the first two years. PCR testing will continue locally thereafter. Therefore, the total duration of the subject participation trial will be approximately five years (one year on consolidation phase + three years in the TFR phase + one year of long-term follow-up post TFR or early discontinuation.

Conditions

• Chronic Phase Chronic Myelogenous Leukemia

Interventions

Type	Name	Description
DRUG	Asciminib 40 MG	40 mg by mouth (PO) when used with imatinib.
DRUG	Asciminib 40 MG Twice Daily	40 mg twice daily when used with nilotinib.
DRUG	Asciminib 80 MG daily	80 mg daily when used with dasatinib or taken alone.
DRUG	Imatinib	Maximum dose of 400 mg PO once daily.
DRUG	Nilotinib	Maximum dose of 300 mg twice daily.
DRUG	Dasatinib	Maximum dose of 100 mg PO once daily.

Timeline

• Start date: 2021-11-11
• Primary completion: 2028-06-01
• Completion: 2029-07-01
• First posted: 2021-04-08
• Last updated: 2025-07-30

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study