A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma

Recruiting Phase 1 Phase 2 Interventional Study
Relapsed/Refractory Primary Central Nervous System Lymphoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. 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 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
38 (estimated)
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine · Other
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About This Trial
This study is a prospective, single-arm, open label, Phase Ib/II clinical study to evaluate the safety and efficacy of selinexor in combination with temozolomide and anti-PD-1 monoclonal antibody in patients with relapsed/refractory primary central nervous system lymphoma(PCNSL). Phase Ib used a "3+3" dose-climbing design to confirm the safety, maximum-tolerated dose (MTD,if any) and recommended p…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Aged between 18 and 75 (inclusive). * Participants must be able to understand and be willing to sign a written informed consent document. * Eastern Cooperative Oncology Group performance status 0 to 3. * Life expectancy of ≥ 3 months (in the opinion of the investigator). * Pri…
Contacts

Xianggui Yuan

+8613989883884

yuanxg@zju.edu.cn

CONTACT

Wenbin Qian

+8613605801032

qianwb@zju.edu.cn

CONTACT