Chronic lymphocytic leukemia, Patients with relapsed CLL
Conditions
Brief summary
uMRD in bone marrow (BM) by flow cytometry after 26 cycles
Detailed description
Depth of MRD measured in BM after cycle 13 and 26, Depth of MRD measured in PB after cycle 8, 10, 13, 16, 19, 22, 26 and every 3-6 months thereafter, Best overall response rate (ORR) defined as the proportion of subjects with a complete response (CR), complete response with incomplete marrow recovery (CRi), or partial response (PR) according to IWCLL 2018 criteria, Progression free survival (PFS), defined as time from registration to the first occurrence of disease progression or death from any cause (whichever occurs first)., Event free survival (EFS), defined as time from registration to date start of first CLL treatment off protocol, progression or death, whichever comes first, Overall survival (OS), defined as the time from registration to death from any cause, Treatment free interval (TFI), defined as date of last protocol treatment to start date of first CLL treatment off protocol, or death from any cause whichever comes first, Incidence and severity of AEs, with severity determined according to NCI CTCAE v5.0, Exploratory: Depth of MRD by different techniques (flow cytometry, circulating tumor DNA (ctDNA), next-generation sequencing), Exploratory: TruCulture and flow cytometry for immune subsets and function, Exploratory: Grading of hematological toxicity according to IWCLL20, Exloratory: Disease-related symptoms and health-related quality of life (HRQoL) measured by following questionnaires: EORTC QLQ-C30, EORTC QLQCLL17 and PRO-CTCAE
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| uMRD in bone marrow (BM) by flow cytometry after 26 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Depth of MRD measured in BM after cycle 13 and 26, Depth of MRD measured in PB after cycle 8, 10, 13, 16, 19, 22, 26 and every 3-6 months thereafter, Best overall response rate (ORR) defined as the proportion of subjects with a complete response (CR), complete response with incomplete marrow recovery (CRi), or partial response (PR) according to IWCLL 2018 criteria, Progression free survival (PFS), defined as time from registration to the first occurrence of disease progression or death from any cause (whichever occurs first)., Event free survival (EFS), defined as time from registration to date start of first CLL treatment off protocol, progression or death, whichever comes first, Overall survival (OS), defined as the time from registration to death from any cause, Treatment free interval (TFI), defined as date of last protocol treatment to start date of first CLL treatment off protocol, or death from any cause whichever comes first, Incidence and severity of AEs, with severity determi | — |
Countries
Belgium, Denmark, Netherlands