lymphoplasmacytic lymphoma, chronic lymphocytic leukemia, mantle cell lymphoma
Conditions
Brief summary
Run-in phase: GMR (GMR; ritonavir-boosted/unboosted) of ibrutinib AUC0-24. Adequate systemic exposure will be concluded if the lower bound of the 90% CI for the GMR exceeds 0.80., Extension phase: Incidence and severity of adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 6.
Detailed description
Run-in phase: Ibrutinib and ritonavir CL, Cmax, Tmax, Cmin., Run-in phase: QoL according to EORTC QLQ-C30, patient reported toxicity according to PRO-CTCAE, Extension phase: Ibrutinib and ritonavir CL, Cmax, Tmax, Cmin, AUC0-24, Extension phase: Adherence to combination therapy of ibrutinib and ritonavir and reasons for discontinuation, Extension phase: ORR, defined as the proportion of patients with complete response (CR) or (very good; VG) partial response (PR) at week 52 according to remission status criteria for CLL, LPL and MCL, Extension phase: Progression-free survival (PFS), Extension phase: Overall survival (OS), Extension phase: Association between overall response rate (ORR) and adverse events, Extension phase: Quality of life (QoL) according to EORTC QLQ-C30, patient reported toxicity according to PRO-CTCAE, Extension phase: Cost savings
Interventions
Sponsors
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Run-in phase: GMR (GMR; ritonavir-boosted/unboosted) of ibrutinib AUC0-24. Adequate systemic exposure will be concluded if the lower bound of the 90% CI for the GMR exceeds 0.80., Extension phase: Incidence and severity of adverse events (AEs) according to Common Terminology Criteria for Adverse Events (CTCAE) version 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Run-in phase: Ibrutinib and ritonavir CL, Cmax, Tmax, Cmin., Run-in phase: QoL according to EORTC QLQ-C30, patient reported toxicity according to PRO-CTCAE, Extension phase: Ibrutinib and ritonavir CL, Cmax, Tmax, Cmin, AUC0-24, Extension phase: Adherence to combination therapy of ibrutinib and ritonavir and reasons for discontinuation, Extension phase: ORR, defined as the proportion of patients with complete response (CR) or (very good; VG) partial response (PR) at week 52 according to remission status criteria for CLL, LPL and MCL, Extension phase: Progression-free survival (PFS), Extension phase: Overall survival (OS), Extension phase: Association between overall response rate (ORR) and adverse events, Extension phase: Quality of life (QoL) according to EORTC QLQ-C30, patient reported toxicity according to PRO-CTCAE, Extension phase: Cost savings | — |
Outcome results
None listed