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

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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Publication Details

Journal
American Journal of Hematology
Published
2026-05-12
DOI
https://doi.org/10.1002/ajh.70366
Primary Topic
Lymphoma Diagnosis and Treatment
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article
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article

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

X Chen, Xiyue Xu, Jialiang Lu, Xiang Weng et al.
American Journal of Hematology
Lymphoma Diagnosis and Treatment
article

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

X Chen, Xiyue Xu, Jialiang Lu, Xiang Weng, Zhilu Chen, Shuailing Peng, Shuiyun Han, Haiyan Yang, Xiu Zhu, Tao Lei, Haifeng Yu, Cong Li
article en

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.

American Journal of Hematology
Chinese Academy of Sciences (CN), Tongde Hospital of Zhejiang Province (CN), Zhejiang Cancer Hospital (CN), Jinhua Academy of Agricultural Sciences (CN), Jinhua Central Hospital (CN)
Good health and well-being
Openalex Percentile: Top 5%
Lymphoma Diagnosis and Treatment
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