A Phase 2 interventional study of Imatinib and Nilotinib 300 mg in Chronic Myeloid Leukemia, sponsored by University of Jena. Active, not recruiting at 21 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by University of Jena · Phase 2, Interventional, and Treatment
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.
Despite the dramatic progress made over the past decade with TKIs in the treatment of CML, allogeneic stem cell transplant remains the only proven curative therapy. To achieve cure or benefit from treatment-free remissions with pharmacologically-based therapies, it is estimated that patients will likely need to achieve a sustained reduction in tumor burden corresponding to a deep molecular response of at least 4 logs (MR4). Currently, only 30.8% of patients achieve a deep molecular response after 12 months of treatment with single agent nilotinib.
The development of the novel and potent BCR-ABL1 allosteric inhibitor, asciminib, presents an opportunity to assess the effect of a different mechanism of inhibition of BCR-ABL1 in the first-line treatment of CML to enhance speed of response and to increase the patient population benefitting from deep molecular response. Dosing a combination of asciminib with an ATP-site inhibitor also has the potential to prevent the emergence of resistance due to point mutations being acquired in one of the binding sites.
The safety, tolerability and pharmacokinetic profile of asciminib as a single agent and in combination with either nilotinib or imatinib or dasatinib was assessed in a phase-I study. At the doses chosen here, all three combination treatments were well tolerated.
Since in all patient cohorts the standard of care therapy will remain the backbone of initial therapy, there is no reason to expect an efficacy problem with the combination therapies.
Exclusion Criteria:
Known impaired cardiac function, including any of the following:
Standard therapy of Imatinib 400 mg QD and asciminib 60 mg QD
Drug: Imatinib · Drug: Asciminib
Standard therapy of Nilotinib 300 mg BID and asciminib 20 mg BID
Drug: Nilotinib 300 mg · Drug: Asciminib
Standard therapy of Nilotinib 300 mg BID and asciminib 40 mg QD
Drug: Nilotinib 300 mg · Drug: Asciminib
Standard therapy of Dasatinib 100 mg QD and asciminib 80 mg QD
Drug: Dasatinib · Drug: Asciminib
Asciminib 80 mg QD as a single agent
Drug: Asciminib
Imatinib 400 mg QD and asciminib 60 mg QD
Also known as: Imatinib 400 mg QD and asciminib 60 mg QD
Nilotinib 300 mg BID and asciminib 20 mg BID or 40 mg QD
Also known as: Nilotinib 300 mg BID and asciminib 20 mg BID or 40 mg QD
Dasatinib 100 mg QD and asciminib 80 mg QD
Also known as: Dasatinib 100 mg QD and asciminib 80 mg QD
Asciminib 80 mg QD Monotherapy
deep molecular response (Rate of MR4)
Achievement of deep molecular response (MR4) throught standardized testing of BCR-ABL-transcript Levels
Time frame: at month 12 after Start of Standard-Therapy
deep molecular Response (Rate of MR4.5)
Achievement of deep molecular response (MR4.5) throught standardized testing of BCR-ABL-transcript Levels
Time frame: at month 36 after Start of Standard-Therapy
molecular response (MMR and MR4.5)
Achievement of deep molecular response throught standardized testing of BCR-ABL-transcript levels
Time frame: at and by 6, 12, 18, 24, 36 and 60 months after Start of Therapy
Adverse Events
Incidence of adverse events grade 1-5 and 3-5
Time frame: at and by baseline, 3, 6, 12, 15, 18, 21, 24, 36 and 60 months after Start of Therapy
Progression free survival
Progression free survival at the end of the study
Time frame: at month 60 after Start of Therapy
Overall survival
Overall survival at the end of the study
Time frame: at month 60 after Start of Therapy
Maintenance of MR4.5 during Asciminib-monotherapy
Achievement of deep molecular response (MR4.5) throught standardized testing of BCR-ABL-transcript Levels
Time frame: at month 36 and 60 after Start of Therapy
Achievement and durability of treatment-free remission
Achievement of deep molecular response (MR4) throught standardized testing of BCR-ABL-transcript Levels
Time frame: months 37 and 60 after Start of Therapy
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive→
University of Jena