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Asciminib as Initial Therapy for Patients With Chronic Myeloid Leukemia in Chronic Phase

NCT05143840 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-23

No results posted yet for this study

Summary

This study is a multicenter Phase 2, non-randomized, open-label single-group frontline study administering asciminib in patients with newly diagnosed Chronic Myeloid Leukemia-Chronic Phase (CML-CP). The aim of this study is to evaluate the efficacy and safety of asciminib in newly diagnosed CML-CP. Patients will receive asciminib 80 mg orally once daily during the single asciminib phase. Response is determined by PCR (polymerase chain reaction) blood test during the study. Patients who have not achieved a response after 24 months (but no later than 36 months) of single agent asciminib will be offered the addition of a low dose tyrosine kinase inhibitor (low-TKI) namely dasatinib, imatinib, or nilotinib at the investigator's discretion. The following doses of the TKIs will be used:

1. Dasatinib 50 mg daily
2. Imatinib 300 mg daily
3. Nilotinib 300 mg daily

Patients will discontinue study treatment if they experience disease progression, or unacceptable toxicity.

Conditions

  • Chronic Myeloid Leukemia, Chronic Phase
  • Adult CML
  • Leukemia, Myeloid
  • Leukemia,Myeloid, Chronic

Interventions

DRUG

Single Agent Asciminib

taken orally once a day starting cycle 1 day 1 for up to 24 months during the single agent asciminib phase. Asciminib is a potent allosteric inhibitor of BCR::ABL1.

COMBINATION_PRODUCT

Low TKI

Low dose tyrosine kinase inhibitor (lowTKI) (dasatinib 50 mg daily or imatinib 300 mg daily or nilotinib 300 mg daily) at investigators discretion, may be added to asciminib in the following situations: * Patients who have treatment failure at any time based on ELN criteria (Appendix 7) * Patients who have a warning response after 12 months of single agent asciminib based on ELN criteria (Appendix 7) * Patients who have not achieved MR4.5 after 24 months, but no later than 36 months, of single agent asciminib.

OTHER

Elective Free Treatment

Once central eligibility has been obtained the patient should discontinue asciminib and if applicable lowTKI within 14 days.

Sponsors & Collaborators

  • H. Jean Khoury Cure CML Consortium

    collaborator OTHER

  • Augusta University

    lead OTHER

Principal Investigators

  • Jorge Cortes, MD · Augusta University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-22
Primary Completion
2032-02-29
Completion
2032-02-29
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05143840 on ClinicalTrials.gov