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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

NCT04838041 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-07-30

No results posted yet for this study

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.

Conditions

  • Chronic Phase Chronic Myelogenous Leukemia

Interventions

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.

Sponsors & Collaborators

  • H. Jean Khoury Cure CML Consortium

    collaborator OTHER

  • Medical College of Wisconsin

    lead OTHER

Principal Investigators

  • Ehab Atallah, MD · Medical College of Wisconsin

  • Michael J. Mauro, MD · Memorial Sloan Kettering Cancer Center

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
2021-11-11
Primary Completion
2028-06-30
Completion
2029-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04838041 on ClinicalTrials.gov