Chronic Lymphocytic Leukemia and Other B-cell Malignancies
Conditions
Brief summary
1. Cohort 1: undetectable measurable residual disease (uMRD) rate: percentage of patients achieving uMRD as measured in peripheral blood mononuclear cells (PBMCs) by the ClonoSEQ assay. Bone marrow aspirate is required to confirm a CR and uMRD by peripheral blood., 2. Cohort 2: ORR: percentage of patients achieving a complete response (CR), or PR using iwCLL Response Criteria guidelines (Hallek et al, 2018)
Detailed description
1. Cohort 1: Duration of uMRD, Time to measurable residual disease (MRD) conversion, complete response (CR) rate, Duration of CR, Time to CR, 2. Cohort 2: Duration of response (DOR), Time to response, 3. Cohort 1 and Cohort 2: • Progression-free survival (PFS), Overall survival (OS) • Incidence of treatment-emergent adverse events (TEAEs) and treatment-related AEs, physical examinations, vital signs, electrocardiograms (ECGs), and laboratory values • PK parameters: Cmax, Tmax, AUC0-t, and Cmin for emavusertib and zanubrutinib
Interventions
Sponsors
Curis Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cohort 1: undetectable measurable residual disease (uMRD) rate: percentage of patients achieving uMRD as measured in peripheral blood mononuclear cells (PBMCs) by the ClonoSEQ assay. Bone marrow aspirate is required to confirm a CR and uMRD by peripheral blood., 2. Cohort 2: ORR: percentage of patients achieving a complete response (CR), or PR using iwCLL Response Criteria guidelines (Hallek et al, 2018) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cohort 1: Duration of uMRD, Time to measurable residual disease (MRD) conversion, complete response (CR) rate, Duration of CR, Time to CR, 2. Cohort 2: Duration of response (DOR), Time to response, 3. Cohort 1 and Cohort 2: • Progression-free survival (PFS), Overall survival (OS) • Incidence of treatment-emergent adverse events (TEAEs) and treatment-related AEs, physical examinations, vital signs, electrocardiograms (ECGs), and laboratory values • PK parameters: Cmax, Tmax, AUC0-t, and Cmin for emavusertib and zanubrutinib | — |
Outcome results
None listed