Asciminib Frontline Risk Adapted

ConditionChronic Myeloid Leukemia (CML)

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorProf. Dr. med. Andreas Hochhaus

About this trial

This is a multi-center, prospective, non-randomized but stratified interventional phase II study of newly diagnosed CML patients in chronic phase. All patients will be treated with asciminib 80 mg QD. Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week 4 weeks after start of asciminib. The study will be conducted in Germany.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent must be obtained prior to participation in the trial

Newly diagnosed patients with BCR::ABL1+ CML-CP up to 12 weeks after diagnosis

Evidence of any BCR::ABL1 transcript except transcripts lacking ABL1 exon a2.

Male or female patients ≥ 18 years of age

Disqualifiers

Previous treatment for CML or any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea for a maximum of 12 weeks or any TKI for a maximum of 2 weeks.

BCR::ABL1 transcripts lacking ABL1 exon a2 (e.g., e13a3, e14a3, e1a3)

Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required)

History of myocardial infarction, angina pectoris, coronary artery bypass graft within 6 months prior to starting study treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

Dasatinib 80mg QD (5 days per week)
Drug
Patients with unfavorable risk factors will commence dasatinib 80 mg 5 days/week 4 weeks after start of asciminib.
Standarc of Care
Drug
Asciminib 80mg QD ist the usual standard of care therapy for CML

Treatment groups

200 Participants

are divided into 2 treatment groups

Group A: asciminib 80 mg QDActive comparator 1 intervention

Group B: Asciminib 80mg QD + Dasatinib 80mg QD (5 times a week)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Rate of MMR at 12 months

rate of response after 12 months

Time frame

12 months after start of therapy

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Prof. Dr. med. Andreas Hochhaus

Lead sponsor

University of Jena

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: