Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|University of Jena|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Thomas Ernst, Prof. Dr.|
|Principal Investigator Affiliation||University Hospital Jena|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Chronic Myeloid Leukemia|
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.
Experimental: Asciminib 60mg QD
Standard therapy of Imatinib 400 mg QD and asciminib 60 mg QD
Experimental: Asciminb 20 mg BID
Standard therapy of Nilotinib 300 mg BID and asciminib 20 mg BID
Experimental: Asciminib 40 mg QD
Standard therapy of Nilotinib 300 mg BID and asciminib 40 mg QD
Experimental: Asciminib 80 mg QD
Standard therapy of Dasatinib 100 mg QD and asciminib 80 mg QD
Experimental: Asciminib 80 mg QD monotherapy
Asciminib 80 mg QD as a single agent
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
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.