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Frontline Asciminib Combination in Chronic Phase CML

NCT03906292 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 125

Last updated 2025-03-10

No results posted yet for this study

Summary

Adult male and female patients with newly diagnosed Philadelphia chromosome positive (Ph+) and/or BCR-ABL1 positive CML can be included in the study until 3 months after diagnosis. A \<4 week pretreatment with hydroxyurea is permitted. Patients treated for \<6 weeks with nilotinib 300 mg BID, imatinib 400 mg QD, dasatinib 100 mg QD or without any therapy are eligible for recruitment and will be allocated to the respective cohort. All patients must provide written informed consent to be enrolled in the trial. Cohorts were designed to allow assessment of QD and BID asciminib based combinations to optimize quality of life and compliance. Patients will not be randomized. In general, cohorts will be filled consecutively. Asciminib therapy will be commenced 12 weeks after start of nilotinib, imatinib or dasatinib and after recovery of hematopoiesis or in case of no therapy so far 6 weeks after diagnosis as first line treatment. Referred patients already treated with imatinib, nilotinib or dasatinib will remain on the initial drug and will be allocated to the respective cohort.

Conditions

  • Chronic Myeloid Leukemia

Interventions

DRUG

Imatinib

Imatinib 400 mg QD and asciminib 60 mg QD

DRUG

Nilotinib 300 mg

Nilotinib 300 mg BID and asciminib 20 mg BID or 40 mg QD

DRUG

Dasatinib

Dasatinib 100 mg QD and asciminib 80 mg QD

DRUG

Asciminib

Asciminib 80 mg QD Monotherapy

Sponsors & Collaborators

  • Ludwig-Maximilians - University of Munich

    collaborator OTHER

  • Novartis Pharmaceuticals

    collaborator INDUSTRY

  • University of Jena

    lead OTHER

Principal Investigators

  • Thomas Ernst, Prof. Dr. · University Hospital Jena

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-19
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03906292 on ClinicalTrials.gov