Clinical Trial to Assess The Efficacy and Safety of the Combination of Tisagenlecleucel And Ibrutinib in Mantle Cell Lymphoma
- Sponsor
- Peter MacCallum Cancer Centre, Australia
- Study ID
- NCT04234061
- Phase
- PHASE2
- Status
- Active Not Recruiting
Conditions
- Mantle Cell Lymphoma Recurrent
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- ibrutinib and Tisagenlecleucel — COMBINATION_PRODUCTSingle-arm study investigating combination of ibrutinib and Tisagenlecleucel treatment
Study Details
This is an open label, multi-center, single-arm, phase II study investigating the efficacy and safety of the combination of ibrutinib and Tisagenlecleucel in twenty patients with relapsed or refractory Mantle Cell Lymphoma (MCL) or who had sub-optimal response to standard therapy in the presence of TP53 mutation.
Key Dates
- Start date
- Apr 7, 2020
- Status verified
- Nov 2024
- Primary completion
- Sep 1, 2027
- Completion
- Sep 1, 2030
Study Design
- Enrollment
- 20 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Singleibrutinib and Tisagenlecleucel
Primary Outcome Measure
Estimate complete response (CR) rate at month 4 following the infusion of Tisagenlecleucel using the Lugano criteria [ Time Frame: 4 months after Tisagenlecleucel infusion using the Lugano criteria ]