UnknownPhase 2/3

Precision Diagnosis Directing HDACi Chidamide Target Therapy for Adult ETP-ALL

China70 participantsStarted 2016-02-14

Plain-language summary

ETP-ALL is a recently recognized high-risk subgroup and the optimal therapeutic approaches are poorly characterized. Based on the pediatric-inspired, PEG-L-asparaginase-intensified and MRD-directed PDT-ALL-2016 protocol, this open-label, one-arm, multi-site trial is aimed to evaluate the safety and effect of a novel oral histone deacetylase inhibitor chidamide for adult ETP-ALL/LBL in CHINA.

Who can participate

Age range14 Years – 55 Years

SexALL

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Inclusion Criteria: * 14-55 years old; * ETP-ALL newly diagnosed; * signed written informed consent Exclusion Criteria: * Pregnant women; * History of pancreatitis; * History of diabetes; * History of active peptic ulcer disease in the past 6 months; * History of arteriovenous thrombosis in the past 6 months; * Severe active infection; * Allergic to any drugs in PDT-ETP-ALL.

What they're measuring

Event free survival

Timeframe: 3 years

Trial details

NCT IDNCT03553238

SponsorNanfang Hospital, Southern Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-30

Contact for this trial

Hongsheng Zhou, MD, Ph.D

+862062787349 zhs1@i.smu.edu.cn

View on ClinicalTrials.gov More Leukemia, Acute trials