RCLARITY: A Prospective Phase II Study of Rituximab Combined With Lenalidomide and Chidamide (RLC) for the Treatment...

Area of Science:

• Hematology
• Oncology
• Clinical Trials

Background:

• Relapsed/refractory angioimmunoblastic T-cell lymphoma (AITL) has a poor prognosis with limited treatment options.
• Novel therapeutic strategies are urgently needed for patients with r/r AITL.

Purpose of the Study:

• To evaluate the efficacy and safety of a chemotherapy-free regimen (rituximab, lenalidomide, and chidamide - RLC) in adult patients with r/r AITL.
• To assess progression-free survival (PFS), overall response rate (ORR), overall survival (OS), duration of response (DoR), and safety of the RLC regimen.

Main Methods:

• A single-arm, multicenter, prospective Phase II trial (RCLARITY) was conducted.
• Twenty-eight adult patients with r/r AITL received rituximab, lenalidomide, and chidamide for up to 6 cycles.
• Primary endpoint was PFS; secondary endpoints included ORR, OS, DoR, and safety.

Main Results:

• The ORR was 71.4% (32.1% complete remission).
• Median PFS was 5.5 months, median OS was 17.6 months, and median DoR was 10.7 months.
• The RLC regimen demonstrated manageable toxicity, with no Grade 5 adverse events or venous thromboembolic events.

Conclusions:

• The RLC regimen exhibits clinically meaningful anti-tumor activity and manageable toxicity in patients with r/r AITL.
• This chemotherapy-free approach represents a promising therapeutic option for this challenging patient population.