Actively Recruiting
Selinexor, High-dose Methotrexate, and Rituximab Combined With Radiotherapy for Newly Diagnosed, Transplant-ineligible Patients With Central Nervous System Lymphoma: An Open-label, Single-arm, Multicenter Phase II Study
Led by Second Affiliated Hospital of Soochow University · Updated on 2025-06-03
26
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase II clinical trial is designed to evaluate a novel combination treatment for patients with newly diagnosed central nervous system lymphoma (CNSL) who are not candidates for stem cell transplantation. The study will assess the safety and effectiveness of combining selinexor (an oral selective nuclear export inhibitor) with high-dose methotrexate and rituximab chemotherapy, followed by low-dose whole-brain radiotherapy (WBRT). Selinexor has shown promise in enhancing the effects of chemotherapy and radiation in blood cancers. Patients enrolled in this open-label, single-arm, multicenter study will receive up to six 21-day treatment cycles. Those who respond well will undergo reduced-dose WBRT and continue selinexor as maintenance therapy. The study will measure how many patients respond to the treatment (overall response rate), how long the response lasts (progression-free survival), overall survival, and safety. This research aims to provide a less toxic and more effective option for treating CNSL in patients who are older or medically unfit for transplantation.
CONDITIONS
Official Title
Selinexor, High-dose Methotrexate, and Rituximab Combined With Radiotherapy for Newly Diagnosed, Transplant-ineligible Patients With Central Nervous System Lymphoma: An Open-label, Single-arm, Multicenter Phase II Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender
- Histologically confirmed primary or secondary CNS lymphoma with CNS-only involvement
- Not eligible for autologous stem cell transplantation due to clinical reasons or patient choice
- At least one measurable brain lesion 1 cm or larger, or positive cerebrospinal fluid cytology/flow cytometry for leptomeningeal disease
- Eastern Cooperative Oncology Group performance status between 0 and 3
- Adequate organ function including specified minimum blood counts, liver and kidney function, and clotting parameters
- Estimated life expectancy of 3 months or longer
- Negative pregnancy test for women able to become pregnant
- Ability to understand and willing to sign informed consent form
You will not qualify if you...
- Lymphoma limited only to the eye (intraocular lymphoma)
- Prior systemic treatment for CNS lymphoma
- Secondary CNS lymphoma with active disease outside the CNS
- Uncontrolled increased pressure inside the skull
- Significant or unstable heart disease including recent heart attack, unstable angina, uncontrolled arrhythmias, severe heart failure, or reduced heart function below 50%
- Other severe uncontrolled medical conditions or active infections needing treatment
- Known active infections with hepatitis B, hepatitis C, or HIV
- Active digestive problems that prevent swallowing or absorbing oral medicine
- Prior treatment with selective inhibitors of nuclear export, including selinexor
- Having another active cancer except certain treated skin, bladder, cervical, prostate, or breast cancers
- Pregnant or breastfeeding, or unwilling to use effective contraception during and for 6 months after treatment
- Any condition judged by the investigator to make participation unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215000
Actively Recruiting
Research Team
B
Bingzong Li
CONTACT
Y
Yuchen Zhang
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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