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Spots Global Cancer Trial Database for Frontline Asciminib Combination in Chronic Phase CML

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Trial Identification

Brief Title: Frontline Asciminib Combination in Chronic Phase CML

Official Title: Frontline Asciminib Combination in Chronic Phase CML

Study ID: NCT03906292

Study Description

Brief 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.

Detailed Description: 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Universitätsklinikum Aachen Medizinische Klinik IV, Aachen, , Germany

Charite Universitätsmeditin Berlin, Campus Virchow Klinikum, Berlin, , Germany

Universitätsklinikum Bonn, Bonn, , Germany

Klinikum Bremen Mitte, Bremen, , Germany

Klinikum Chemnitz gGmbH, Chemnitz, , Germany

GOKOS GmbH, Dresden, , Germany

Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, , Germany

Universitätsklinikum Erlangen, Erlangen, , Germany

Universitätsklinikum Essen, Essen, , Germany

Universitätsklinikum Frankfurt, Frankfurt, , Germany

Universitätsklinikum Freiburg, Freiburg, , Germany

Universitätsklinikum Jena, Jena, , Germany

Universitätsklinikum Leipzig, Leipzig, , Germany

Gemeinschaftspraxis Dres. Müller/ Kröning/ Jentsch-Ullrich/ Tietze/ Krogel, Magdeburg, , Germany

Universitätsmedizin der Johannes- Gutenberg Universität Mainz, Mainz, , Germany

Universitätsmedizin Mannheim, Mannheim, , Germany

Universitätsklinikum Gießen und Marburg, Marburg, , Germany

Klinikum rechts der Isar, München, , Germany

Brüderkrankenhaus St. Josef Paderborn, Paderborn, , Germany

Krankenhaus Barmherzige Brüder Regensburg, Regensburg, , Germany

Universitätsklinikum Ulm, Ulm, , Germany

Contact Details

Name: Thomas Ernst, Prof. Dr.

Affiliation: University Hospital Jena

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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