NCT05864742View on ClinicalTrials.gov

Genetically Risk-Stratified Venetoclax, Ibrutinib, Rituximab (± Navitoclax) in Relapsed/Refractory Mantle Cell Lymphoma

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 7, 2023

Primary Completion Date

June 1, 2026

Study Completion Date

June 1, 2029

Conditions
Mantle Cell Lymphoma Refractory
Interventions
DRUG

Ibrutinib

560 mg daily continuously

DRUG

Venetoclax

Oral daily. Dose escalation every 7 days (if no TLS) 20mg, 50mg, 100mg, 200mg and 400mg

DRUG

Navitoclax

Oral daily. Dose-escalation every 14 days (if plt \>75x10\^9/L) 50mg, 100mg, 150mg, and 200mg (target dose)

DRUG

Rituximab

375mg/m2, intravenous. To be given on day 1 of weeks 1, 2, 3, 4 of C1 and day 1 of C2-C8

Trial Locations (3)

3000

Peter MacCallum Cancer Centre, Parkville

4102

Princess Alexandra Hospital, Woolloongabba

5042

Flinders Medical Centre, Bedford Park

All Listed Sponsors
lead

Peter MacCallum Cancer Centre, Australia

OTHER

NCT05864742 - Genetically Risk-Stratified Venetoclax, Ibrutinib, Rituximab (± Navitoclax) in Relapsed/Refractory Mantle Cell Lymphoma | Biotech Hunter | Biotech Hunter