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Tazemetostat + Amdizalisib in R/R Lymphoma
NCT05713110Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2023
- Primary completion
- Dec 2024
- Countries
- 1
- Sponsor
- HUTCHMED
- Modality
- Small Molecules
- Drugs
- amdizatinib
- Conditions
- diffuse large B-cell lymphoma (DLBCL)Follicular lymphoma (FL)Mantle cell lymphoma (MCL)peripheral T-cell lymphoma (PTCL)
01
Overview
Phase 2, open-label, single-arm trial of amdizatinib in diffuse large B-cell lymphoma (DLBCL), Follicular lymphoma (FL), Mantle cell lymphoma (MCL) and 1 more, sponsored by HUTCHMED. Primary endpoints: Maximum Tolerated Dose / Recommended Phase 2 Dose, Objective Response Rate and 3 more. Started Feb 2023; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Tazemetostat + Amdizalisib
Combination of Tazemetostat (800 mg BID) and Amdizalisib (HMPL-689) orally in 28-day cycles.
03
Who it enrols
Adult patients with histologically confirmed relapsed/refractory lymphoma (DLBCL, FL, MCL, PTCL) who have failed or cannot tolerate standard treatment. Patients must have measurable disease and adequate organ function. Prior treatment with EZH2 or PI3K inhibitors is excluded.
04
Endpoints
Primary
Maximum Tolerated Dose / Recommended Phase 2 Dose
Objective Response Rate
Disease Control Rate
Duration of Response
Progression-Free Survival
Secondary
Objective Response Rate
Complete Response Rate
Overall Survival
Time to Maximum Concentration
Maximum Concentration
Area Under the Curve
Minimum Observed Concentration
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