Actively Recruiting
A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-07-31
38
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 phaseII dose (RP2D) of selinexor in combination with fixed dose of temozolomide and anti-PD-1 monoclonal antibody for 6 cycles. Phase II was a comprehensive evaluation of efficacy and safety. Subjects who achieved complete remission or partial remission were treated with anti-PD-1 monoclonal antibody maintenance therapy until disease progression or recurrence, intolerance of toxicity, death, loss of follow-up, withdrawal of notification (whatever happened first).
CONDITIONS
Official Title
A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years inclusive
- Able to understand and willing to sign informed consent
- Eastern Cooperative Oncology Group performance status between 0 and 3
- Life expectancy of at least 3 months
- Primary central nervous system lymphoma of B-cell origin confirmed by pathology
- Measurable disease with at least 1.0 cm in short diameter by enhanced MRI
- Recurrent or refractory PCNSL with at least one prior methotrexate-based systemic treatment
- Non-hematological toxicities from previous treatments resolved to grade 1 or normal (except hair loss)
- Adequate bone marrow and organ function without recent blood transfusion or medications to correct counts
- Women of reproductive potential must agree to use effective birth control during therapy and for 6 months after
- Sexually active men must agree to use effective contraception during therapy and for 6 months after
- Able to undergo multiple MRI/CT and lumbar puncture exams
- Able to swallow oral tablets or capsules without difficulty
- Good compliance and willingness to follow visit, dosing, laboratory, and test schedules
You will not qualify if you...
- Diagnosis of T cell lymphoma
- Anti-tumor therapy (chemotherapy, radiotherapy, immunotherapy, antibody drugs, or targeted therapy) within 2 weeks prior to study or specific therapies within longer time frames
- Participation in another investigational study within 4 weeks before treatment
- Use of systemic adrenal corticosteroids for more than 5 days in 14 days prior or need for high-dose dexamethasone daily
- Active concurrent malignancy requiring treatment
- Prior treatment with temozolomide or anti-PD-1/PD-L1/PD-L2 drugs within 6 months
- Uncontrolled or significant cardiovascular disease including specific heart conditions and arrhythmias
- Uncontrolled infections or those requiring intravenous antibiotics
- Active hepatitis B or C infection or syphilis; certain HBV and HCV carriers allowed
- HIV infection
- Significant gastrointestinal problems affecting drug intake or absorption
- Prior allogenic stem cell transplant
- Currently pregnant or breastfeeding females
- Allergy to study drug or excipients
- Active mental illness or substance abuse
- Life-threatening diseases or conditions affecting safety or compliance
- Other conditions deemed inappropriate by the investigator for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
X
Xianggui Yuan
CONTACT
W
Wenbin Qian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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