Golidocitinib Versus Placebo as Maintenance Therapy in PTCL Patients With Response (CR/PR) After First-Line Chemotherapy

Recruiting Phase 3 Interventional Study
Peripheral T Cell Lymphoma
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
68 (estimated)
Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Other
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About This Trial
This is a multicenter, randomized, double-blind, phase III clinical study comprising two arms: a golidocitinib group and a placebo group. The study aimed to evaluate the antitumor efficacy and safety of golidocitinib in patients who had achieved a response after first-line systemic therapy and were ineligible for hematopoietic stem cell transplantation. The investigational intervention consisted o…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * The subject must sign the informed consent form (ICF) in accordance with the relevant procedures described in the chapter, and be willing and able to comply with the requirements and restrictions listed in the ICF and this study protocol. * Age \>18 years at the time of signin…
Contacts

xianmin Song, MD

18616705298

shongxm@139.com

CONTACT