Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic M… (NCT03578367) | Clinical Trial Compass
CompletedPhase 2
Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response.
United States, Austria, Canada104 participantsStarted 2018-11-22
Plain-language summary
To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP). An asciminib single agent arm (80 mg daily) was added after the primary analysis to evaluate if asciminib alone could lead to MR4.5 patients in Imatinib for at least one year who have never achieved deep molecular response (DMR).
Who can participate
Age range18 Years – 100 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female patients ≥ 18 years of age with a confirmed diagnosis of CML-CP.
* Minimum of one year (12 calendar months) treatment with imatinib first line for CML-CP (patients have to be on imatinib 400 mg QD at randomization and had no dose change in the past three months).
For Korea only:
(i) a minimum of one year (12 calendar months) of prior treatment with imatinib for patients with BCR::ABL1 levels \> 0.1%, ≤ 1% IS at the time of randomization.
(ii) a minimum of two years (24 calendar months) of prior treatment with imatinib for patients with BCR::ABL 1 levels \> 0.01%, ≤ 0.1% IS at the time of randomization.
* BCR::ABL1 levels \> 0.01% IS (International Scale) and ≤ 1% IS at the time of randomization as confirmed with a central assessment at screening; patients must not have achieved deep molecular response (MR4 IS) confirmed by 2 consecutive tests at any time during prior imatinib treatment. An isolated, single test result with BCR::ABL1 levels \< 0.01 % (MR4 IS) is allowed, however, it should not have been observed within the 9 months prior to randomization
* Patient must meet the following laboratory values before randomization:
* Absolute Neutrophil Count ≥ 1.5 x 10E9/L
* Platelets ≥ 75 x 10E9/L
* Hemoglobin ≥ 9 g/dL
* Serum creatinine \< 1.5 mg/dL
* Total bilirubin ≤ 1.5 x ULN (Upper Limit of Normal) except for patients with Gilbert's syndrome who may only be included with total bilirubin ≤ 3.0 x ULN
* Aspartate transaminase (AST) ≤ 3.…
What they're measuring
1
Molecular Response (MR)^4.5 Rate at 48 Weeks and Difference in Rate Between Asciminib + Imatinib and Imatinib Alone