A phase IIIb, multi-center, open-label, treatment optimization study of oral asciminib in patients with Chronic Myelogenous Leukemia in chronic phase (CMLCP) previously treated with 2 or more tyrosine kinase inhibitors

Conditions

Chronic Myelogenous Leukemia in chronic phase (CML-CP)

Brief summary

MMR at 48 weeks

Detailed description

Type, frequency and severity of adverse events, changes in laboratory values that fall outside the pre-determined ranges and clinically notable ECG and other safety data (vital signs, physical examination)., MMR rate at weeks 12, 24, 36, 72, 96 and 144., MMR rate at week 48 for patients with MMR at baseline., Time from the date of randomization to the date of first documented MMR, Rate of BCR-ABL1 ≤ 10% and ≤1% at weeks 12, 24, 36 and 48, Rate of MR4 and MR4.5 at weeks 12, 24, 36, 48, 72, 96 and 144., Rate of complete cytogenetic response (CCyR) at weeks 48 and EOT., Additional chromosomal abnormalities and occurrence of high-risk ACAs, Rate of BCR-ABL1 ≤ 10%, BCR-ABL1 ≤1%, MMR, MR4 and MR4.5 by all-time points., Duration of MMR., Duration of MR4 without loss of MMR., Time from randomization to death., Time from randomization to treatment failure defined as BCR-ABL1 > 1%., Change in symptom burden and interference from baseline over time according to the MDASI-CML PRO instrument., Time from randomization to the earliest occurrence of documented disease progression to AP/BC or death

Related papers

No related papers found yet.

Interventions

DRUGASCIMINIB HYDROCHLORIDE

DRUGASCIMINIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
MMR at 48 weeks	—

Secondary

Measure	Time frame
Type, frequency and severity of adverse events, changes in laboratory values that fall outside the pre-determined ranges and clinically notable ECG and other safety data (vital signs, physical examination)., MMR rate at weeks 12, 24, 36, 72, 96 and 144., MMR rate at week 48 for patients with MMR at baseline., Time from the date of randomization to the date of first documented MMR, Rate of BCR-ABL1 ≤ 10% and ≤1% at weeks 12, 24, 36 and 48, Rate of MR4 and MR4.5 at weeks 12, 24, 36, 48, 72, 96 and 144., Rate of complete cytogenetic response (CCyR) at weeks 48 and EOT., Additional chromosomal abnormalities and occurrence of high-risk ACAs, Rate of BCR-ABL1 ≤ 10%, BCR-ABL1 ≤1%, MMR, MR4 and MR4.5 by all-time points., Duration of MMR., Duration of MR4 without loss of MMR., Time from randomization to death., Time from randomization to treatment failure defined as BCR-ABL1 > 1%., Change in symptom burden and interference from baseline over time according to the MDASI-CML PRO instrument., Time	—

Measure

Time frame

Type, frequency and severity of adverse events, changes in laboratory values that fall outside the pre-determined ranges and clinically notable ECG and other safety data (vital signs, physical examination)., MMR rate at weeks 12, 24, 36, 72, 96 and 144., MMR rate at week 48 for patients with MMR at baseline., Time from the date of randomization to the date of first documented MMR, Rate of BCR-ABL1 ≤ 10% and ≤1% at weeks 12, 24, 36 and 48, Rate of MR4 and MR4.5 at weeks 12, 24, 36, 48, 72, 96 and 144., Rate of complete cytogenetic response (CCyR) at weeks 48 and EOT., Additional chromosomal abnormalities and occurrence of high-risk ACAs, Rate of BCR-ABL1 ≤ 10%, BCR-ABL1 ≤1%, MMR, MR4 and MR4.5 by all-time points., Duration of MMR., Duration of MR4 without loss of MMR., Time from randomization to death., Time from randomization to treatment failure defined as BCR-ABL1 > 1%., Change in symptom burden and interference from baseline over time according to the MDASI-CML PRO instrument., Time

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Countries

Austria, France, Germany, Greece, Italy, Poland, Spain

Outcome results

None listed