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Ibrutinib in Untreated High Risk Smoldering Mantle Cell Lymphoma
NCT03282396Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Jun 2020
- Primary completion
- Feb 2028
- Countries
- 1
- Sponsor
- University of Texas MD Anderson Cancer Center
- Modality
- Small Molecules
- Drugs
- ibrutinib
- Conditions
- mantle cell lymphoma (MCL)
01
Overview
Phase 2, open-label, single-arm trial of ibrutinib in mantle cell lymphoma (MCL), sponsored by University of Texas MD Anderson Cancer Center. Primary endpoint: Progression-Free Survival up to 3.5 years. Started Jun 2020; status: active, not recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (ibrutinib)
Participants receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days for 5 years in the absence of disease progression or unacceptable toxicity.
03
Who it enrols
Adults with previously untreated, high-risk smoldering mantle cell lymphoma (CD20+, cyclin D1+) with measurable disease, adequate organ function, and no prior BTK inhibitor exposure.
04
Endpoints
Primary
Progression-Free Survival
Secondary
Incidence of adverse events
Response rate
Response duration
Overall survival
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