INCB 50465-205 (CITADEL-205) (R/R)
A phase 2, open-label, 2-cohort, multicenter study of INCB050465, a PI3Kδ inhibitor, in relapsed or refractory mantle cell lymphoma previously treated with or without a BTK inhibitor (CITADEL-205)
Study treatments
| Experimental cohort 1
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Participants who have previously received ibrutinib --> INCB50465 will be given at the protocol-defined dose
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| Experimental cohort 2
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Participants who have not previously received a BTK inhibitor --> INCB50465 will be given at the protocol-defined dose
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Inclusion criteria
- Age 18 years and older
- Documented failure to achieve at least PR with, or documented disease progression after, the most recent treatment regimen
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
- ECOG score of 0-2
Exclusion criteria
- History of central nervous system lymphoma
- Prior treatment with idelalisib, other selective PI3Kδ inhibitors, or a pan PI3K inhibitor
- Allogneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of first dose of study treatment
- Active graft-versus-host disease
Participating sites
- Ghent University Hospital
- Institut Jules Bordet
- AZ Groeninge Kortrijk
- Centre Hospitalier de Jolimont
- Centre Hospitalier Universitaire UCL Namur