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

Chronic Phase Chronic Myelogenous Leukemia Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

All eligible patients will begin asciminib in combination with a TKI on cycle 1 day 1 of the combination phase. They will continue combination therapy for a total of 12 cycles (minimum of 12 months). Each cycle will be ~28 days. 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 also discontinue their TKI and be monitored off treatment. The primary endpoint of this study is the 12-month 'second' TFR rate after completion of 12 cycles of combination 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. Therefore, the total duration of the subject participation trial will be approximately five years (one year on combination treatment phase plus three years in the TFR phase plus one year of long-term follow-up post TFR or early discontinuation. ;

Related Conditions & MeSH terms

• Chronic Phase Chronic Myelogenous Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Leukemia, Myeloid, Chronic-Phase

• NCT number: NCT04838041
• Study type: Interventional
• Source: Medical College of Wisconsin
• Contact: Medical College of Wisconsin Cancer Center Clinical Trials Offic
• Phone: 414-805-8900
• Email: cccto@mcw.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: November 11, 2021
• Completion date: July 2029