Targeted Drug Combined With CHOP in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

Phase 2 Unknown 96 enrolled Ruijin Hospital

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This prospective，multi-center，open-label, controlled study will evaluate the efficacy and safety of targeted drug in combination with CHOP in treatment of newly diagnosed peripheral T-cell lymphoma.

Timeline

Start: 2020-07-29
Primary completion: 2023-04-20
Completion: 2024-04

Outcome

Met primary endpoint

paper The study met its primary endpoint. PMID 39175480 ↗

paper CRR at EOT in the CHOPX group was superior to the CHOP group (64.6% vs. 33.3%, OR 0.27, 95%CI 0.12-0.64; p = 0.004). PMID 39175480 ↗

Publications

Cai MC, Cheng S, Jing HM, Liu Y, Cui GH, Niu T, Shen JZ, Huang L, Wang X, Huang YH, Wang L, Xu PP, Zhao WL. Targeted agents plus CHOP compared with CHOP as the first-line treatment for newly diagnosed patients with peripheral T-cell lymphoma (GUIDANCE-03): an open-label, multicentre phase 2 clinical trial. Lancet Reg Health West Pac. 2024 Jul 29;50:101160. doi: 10.1016/j.lanwpc.2024.101160. eCollection 2024 Sep.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Azacitadine	Unknown	100 mg	Intravenous
Subject	Decitabine	Small molecule	10 mg/m2	Intravenous
Subject	Lenalidomide	Other / unclassified	25 mg	Oral
Subject	Tucidinostat	Small molecule	20 mg	Oral
Comparator	Cyclophosphamide	Other / unclassified	750 mg/m2	Intravenous
Comparator	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Comparator	Prednisone	Other / unclassified	60 mg/m2	Oral
Comparator	Vincristine	Small molecule	1.4 mg/m2	Intravenous