Trials / Active Not Recruiting
Active Not RecruitingNCT04234061
Clinical Trial to Assess The Efficacy and Safety of the Combination of Tisagenlecleucel And Ibrutinib in Mantle Cell Lymphoma
A Phase II, Open-Label, Single Arm Trial to Assess The Efficacy and Safety of the Combination of Tisagenlecleucel And Ibrutinib in Mantle Cell Lymphoma
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Peter MacCallum Cancer Centre, Australia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| COMBINATION_PRODUCT | ibrutinib and Tisagenlecleucel | Single-arm study investigating combination of ibrutinib and Tisagenlecleucel treatment |
Timeline
- Start date
- 2020-04-07
- Primary completion
- 2027-09-01
- Completion
- 2030-09-01
- First posted
- 2020-01-21
- Last updated
- 2024-11-07
Locations
1 site across 1 country: Australia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04234061. Inclusion in this directory is not an endorsement.