Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at Fresno, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

A Phase II Multicenter, Open-label, Single-arm Dose Escalation Study of Asciminib Monotherapy in 2nd and 1st Line Chronic Phase - Chronic Myelogenous Leukemia (ASC2ESCALATE)

Details

Keywords

Chronic Myelogenous Leukemia - Chronic Phase, CML, Chronic Phase, Asciminib, ASC2ESCALATE, T315I mutation, BCR-ABL, MMR, TKI, Tyrosine Kinase Inhibitor, molecular response, adult, Leukemia, Myeloid Leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Chronic-Phase

Eligibility

Locations

  • UCSF Fresno Internal Medicine
    Fresno California 93701 United States
  • Alta Bates Summit Medical Center
    Oakland California 94609 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT05384587
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 196 people participating
Last Updated