Relapsed/refractory chronic lymphocytic leukemia
Conditions
Brief summary
Negativity rate of minimal residual disease (MRD) in peripher-al blood (PB) measured by multi-color flow cytometry at final restaging (RE) at the end of induction treatment (12 weeks after the start of the last induction cycle)
Detailed description
Overall response rate (ORR) according to iwCLL criteria at RE 12 weeks after the start of the last cycle of induction ther-apy including all patients achieving: - a complete response (CR), - CR with incomplete recovery of the bone marrow (CRi), or - a partial response (PR), CR/CRi rate at RE 12 weeks after the start of the last cycle of induction therapy, Safety parameters: Type, frequency, severity, and relation-ship to study treatment of - adverse events (AE), - serious adverse events (SAE) and - adverse events of particular/special interest (AEPI/AESI), MRD in PB measured by 4-color flow cytometry to guide the duration of maintenance therapy at: - RE 12 weeks after the start of the last cycle of induc-tion therapy in all patients responding to study treat-ment and - every 12 weeks (= approx. 3 months) during the maintenance phase - every 24 weeks (= approx. 6 months) during the fol-low-up, and MRD in PB measured by 4-color flow cytometry for the assessment of the kinetics of response to the different treat-ment phases at: - screening/baseline - staging after debulking (if applicable) - before start with zanubrutinib (cycle 2, d1) - before start with venetoclax (cycle 3, d1) - interim staging (after 3 induction cycles) - initial response assessment (after 6 induction cycles), MRD in bone marrow measured by 4-color flow cytometry op-tionally in patients with (clin.) CR/CRi (or PR almost fulfilling CR criteria, e.g. with residual splenomegaly) 12 weeks after achievement of MRD negativity in PB, Best response rate (BRR) until 6 months after RE, ORR after debulking, ORR after end of maintenance treatment, Progression-free survival (PFS), Event-free survival (EFS), Overall survival (OS), Duration of response in patients with - a complete response (CR), - a CR with incomplete recovery of the bone marrow (CRi), - a partial response (PR), Treatment-free survival (TFS) and time to next CLL treatment (TTNT)
Interventions
Sponsors
University Of Cologne
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negativity rate of minimal residual disease (MRD) in peripher-al blood (PB) measured by multi-color flow cytometry at final restaging (RE) at the end of induction treatment (12 weeks after the start of the last induction cycle) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) according to iwCLL criteria at RE 12 weeks after the start of the last cycle of induction ther-apy including all patients achieving: - a complete response (CR), - CR with incomplete recovery of the bone marrow (CRi), or - a partial response (PR), CR/CRi rate at RE 12 weeks after the start of the last cycle of induction therapy, Safety parameters: Type, frequency, severity, and relation-ship to study treatment of - adverse events (AE), - serious adverse events (SAE) and - adverse events of particular/special interest (AEPI/AESI), MRD in PB measured by 4-color flow cytometry to guide the duration of maintenance therapy at: - RE 12 weeks after the start of the last cycle of induc-tion therapy in all patients responding to study treat-ment and - every 12 weeks (= approx. 3 months) during the maintenance phase - every 24 weeks (= approx. 6 months) during the fol-low-up, and MRD in PB measured by 4-color flow cytometry for the assessment of the kinetics of re | — |
Countries
Germany
Outcome results
None listed