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May 15, 2026American Journal of Hematology0 citations

RCLARITY : A Prospective Phase II Study of Rituximab Combined With Lenalidomide and Chidamide ( RLC ) for the Treatment of Relapsed/Refractory Angioimmunoblastic T‐Cell Lymphoma

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CLCong LiTLTao LeiXXXiyue Xu

Key Points

  • The aim was to assess the efficacy and safety of a combination treatment for relapsed/refractory angioimmunoblastic T-cell lymphoma.
  • Phase II trial involving 28 patients with relapsed/refractory angioimmunoblastic lymphoma.
  • Treated with rituximab, lenalidomide, and chidamide for up to 6 cycles in 28-day intervals.
  • Primary endpoint was progression-free survival with secondary endpoints including overall response rate and overall survival.
  • Overall response rate was 71.4%, with 32.1% achieving complete remission.
  • Median progression-free survival was 5.5 months (95% CI, 3.5-7.6) and median overall survival was 17.6 months (95% CI, 10.3-24.8).
  • 50% of patients with clonal Ig rearrangements achieved progression-free survival > 16 months.

Abstract

intravenously on Day 1), lenalidomide (15 mg orally on Days 1-21), and chidamide (30 mg orally twice weekly) in 28-day cycles for up to 6 cycles. The primary endpoint was progression-free survival (PFS). Secondary endpoints included the overall response rate (ORR), OS, duration of response (DoR), and safety. In total, 28 patients were enrolled between August 2019 and June 2024. The median age was 64 years (range, 44-70), and 71.4% had refractory disease. The ORR was 71.4% (complete remission: 32.1%), median PFS was 5.5 months (95% confidence interval CI, 3.5-7.6), median OS was 17.6 months (95% CI, 10.3-24.8), and median DoR among responders was 10.7 months (95% CI, 2.7-16.0). Notably, 50% of patients with clonal Ig heavy- or light-chain rearrangements achieved PFS > 16 months. All nine patients with baseline serum EBV-DNA positivity converted to undetectable levels after two cycles. No Grade 5 adverse events or venous thromboembolic events occurred. The most common hematological adverse events per cycle were leukopenia (14.3%), thrombocytopenia (12.4%), and neutropenia (11.4%). Overall, the RLC regimen induced clinically meaningful anti-tumor activity with manageable toxicity in patients with r/r AITL. Trial Registration: ClinicalTrials.gov identifier: NCT04319601.

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Cite This Study

Li et al. (2026) studied this question.

synapsesocial.com/papers/6a06b8dfe7dec685947ab6b1https://doi.org/10.1002/ajh.70366
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