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.
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