Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Conditions
Brief summary
PFS assessed by IRC defined as the time from randomization to the first occurrence of progression or relapse using the iwCLL guidelines (Hallek Metal 2018) or death from any cause, whichever occurs first.
Detailed description
Key secondary endpoint: Overall survival (OS) defined as the time from randomization to the time of death from any cause., Other secondary efficacy endpoints: PFS assessed by investigator is defined as the time from randomization to the first occurrence of progression or relapse using the iwCLL guidelines (Hallek Metal 2018) or death from any cause, whichever occurs first., Other secondary efficacy endpoints: Overall response rate (ORR) is defined as the proportion of patients with complete response (CR), complete response with incomplete recovery (CRi) and partial repose (PR)., Other secondary efficacy endpoints: Proportion of patients with CR/CRi., Other secondary efficacy endpoints: Duration of Response., Other secondary efficacy endpoints: Proportion of patients with undetectable minimal residual disease., Safety endpoints: Incidence and severity of adverse events, serious adverse events and changes in laboratory results, including hematology and biochemistry, during and within 30 days of treatment discontinuation., Safety endpoints: Incidence of adverse events of interest, including atrial fibrillation and tumor lysis syndrome., Pharmacokinetics endpoint: Population PK analysis., Patient-Reported Outcome (PRO) Measures endpoint: The PRO outcome measures will evaluate the European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire Core-30 (QLQ-C30) and associated CLL module (QLQ-CLL17)., Health Economics and Outcomes Research (HEOR) endpoint: A EuroQoL5-Dimension (EQ-5D-5L) questionnaire will be used
Interventions
Sponsors
Ascentage Pharma Group Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS assessed by IRC defined as the time from randomization to the first occurrence of progression or relapse using the iwCLL guidelines (Hallek Metal 2018) or death from any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoint: Overall survival (OS) defined as the time from randomization to the time of death from any cause., Other secondary efficacy endpoints: PFS assessed by investigator is defined as the time from randomization to the first occurrence of progression or relapse using the iwCLL guidelines (Hallek Metal 2018) or death from any cause, whichever occurs first., Other secondary efficacy endpoints: Overall response rate (ORR) is defined as the proportion of patients with complete response (CR), complete response with incomplete recovery (CRi) and partial repose (PR)., Other secondary efficacy endpoints: Proportion of patients with CR/CRi., Other secondary efficacy endpoints: Duration of Response., Other secondary efficacy endpoints: Proportion of patients with undetectable minimal residual disease., Safety endpoints: Incidence and severity of adverse events, serious adverse events and changes in laboratory results, including hematology and biochemistry, during and within 30 | — |
Countries
Belgium, Bulgaria, Czechia, France, Germany, Hungary, Italy, Poland, Romania, Slovakia, Spain
Outcome results
None listed