Upfront allo-HSCT after intensive chemotherapy for untreated aggressive ATL: JCOG0907, a single-arm, phase 3 trial.

• DOI: 10.1200/jco.2024.42.16_suppl.7001
• Publication Date: 2024-06-28T20:19:52Z
• Authors: Takuya Fukushima; Kunihiro Tsukasaki; Ryunosuke Machida; Dai Maruyama; Shinichi Makita; Shigeru Kusumoto; Shinsuke Iida; Masahito Tokunaga; Yasushi Miyazaki; Makoto Yoshimitsu; Ilseung Choi; Sawako Nakachi; Kana Miyazaki; Junya Makiyama; Kisato Nosaka; Hiroo Katsuya; Toshiro Kawakita; Taro Shibata; Haruhiko Fukuda; Hirokazu Nagai
• Keywords: Total body irradiation; Clinical endpoint

7001 Background: Aggressive adult T-cell leukemia-lymphoma (ATL) (i.e., acute, lymphoma and unfavorable chronic types) has poor prognosis with around a 1-year median survival time (MST) chemotherapy. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) provides durable response 3-year overall (3-y OS) of 40%. However, the results were mostly from retrospective studies. This single-arm, phase 3 trial by Japan Clinical Oncology Group (JCOG) evaluated upfront allo-HSCT for aggressive ATL (jRCTs031180243). Methods: Patients (pts) newly diagnosed who wished to receive eligible. At initiation, JCOG0907 was restricted myeloablative (MAST) pts aged ≤ 55 years. After protocol amendment in September 2014, reduced intensity (RIST) 56-65 years allowed. The treatment VCAP-AMP-VECP as induction chemotherapy based on JCOG9801 OS 24%) followed upon first remission an HLA-matched or 1-locus mismatched related donor, unrelated (UR) donor. MAST regimens consisted busulfan (BU)/cyclophosphamide (CPA) donors total body irradiation (TBI)/CPA UR donors. RIST BU/fludarabine (FLU) FLU/BU/TBI primary endpoint 3-y all registered pts. study whether lower limit two-sided 90% CI exceeded threshold 25%. Results: Between 2010 June 2020, 110 (72 27 lymphoma, 10 1 other) enrolled. Of 92 received (all transplants), 41 (19 22 RIST, 12 29 UR) per-protocol (study transplant) 51 (11 related, 15 25 cord blood) not specified protocol, 35 whom during 16 after progression. met 44.0% (90% CI, 36.0-51.6). MST 3.0 (95% 1.5-5.8) transplants 2.5 1.4-4.8) transplants. Multivariable analysis time-dependent covariate presence absence transplant revealed hazard ratio compared non-study 0.92 0.55-1.51). In transplants, treatment-related deaths (TRD) 16.7% 20.7% Among 70 died, causes death disease progression 34, TRD due 9, post-protocol 21, other 6. Conclusions: Upfront can be recommended chemotherapy-sensitive ATL, but its benefit is clear considering immortal bias suggested multivariable covariate. information: jRCTs031180243 .