A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in A… (NCT05456191) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)
United States568 participantsStarted 2022-11-21
Plain-language summary
The primary purpose of this study was to assess the tolerability of oral asciminib (80 mg QD) in comparison with that of the second generation (2G) Tyrosine Kinase Inhibitor (TKI) nilotinib (300 mg BID), in adult patients with newly diagnosed Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).
Who can participate
Age range18 Years – 100 Years
SexALL
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Key Inclusion Criteria:
* Signed informed consent must be obtained prior to participation in the study.
* Male or female patients ≥ 18 years of age.
* Patients with CML-CP within 3 months of diagnosis.
* Diagnosis of CML-CP (European Leukemia Network \[ELN\] 2020 criteria) with cytogenetic confirmation of the Philadelphia (Ph) chromosome. A cryptic Ph chromosome should be confirmed by metaphase Fluorescence in situ Hybridization (FISH)
* Documented chronic phase CML will meet all the below criteria (Baccarani et al 2013):
* \< 15% blasts in peripheral blood and bone marrow,
* \< 30% blasts plus promyelocytes in peripheral blood and bone marrow,
* \< 20% basophils in the peripheral blood,
* Platelet (PLT) count ≥ 100 x 109/L (≥ 100,000/mm3),
* No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.
* Evidence of typical BCR::ABL1 transcript \[e14a2 and/or e13a2\] which is amenable to standardized RQ-PCR quantification by the central laboratory assessment. However, if a local qualitative assay, validated according to local regulation, from an accredited local laboratory has confirmed evidence of typical BCR::ABL1 transcript \[e14a2 and/or e13a2\], these results can be used for eligibility if the central Real Time Quantitative Polymerase Chain Reaction (RQ-PCR) results arrived are not available at the time of randomization.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate end organ function a…
What they're measuring
1
Time to discontinuation of study treatment due to adverse event (TTDAE).
Timeframe: From date of first dose to date of treatment discontinuation due to AE, assessed up to 5 years