Actively Recruiting
Selinexor in Combination With MTX+Ritu to Treat R/R CNSL
Led by Tong Chen, MD · Updated on 2025-09-16
30
Participants Needed
5
Research Sites
178 weeks
Total Duration
On this page
Sponsors
T
Tong Chen, MD
Lead Sponsor
A
Antengene Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm and open-label study to explore X+MTX+Ritu (ATG-010, Methotrexate, Rituximab) regimen in Relapse refractory PCNSL patients. Approximately 30 patients will be enrolled in the study. In dose escalation phase, patients with Relapse refractory PCNSL will be treated with X+MTX+Ritu regimen and escalating doses of oral ATG-010 weekly in a 3+3 design. Then a phase 2 expansion at the recommended dose level based on phase 1b trial will be conducted to evaluate the efficacy, safety and tolerability.
CONDITIONS
Official Title
Selinexor in Combination With MTX+Ritu to Treat R/R CNSL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent
- Men and women aged 18 to 75 years at consent
- Histologically confirmed primary CNS lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL) from diffuse large B-cell lymphoma
- Relapsed or refractory PCNSL or SCNSL
- Response or stable disease for 2 months after prior methotrexate-based treatment
- Prior autologous hematopoietic stem cell transplantation allowed
- Parenchymal lesions with clear disease progression on imaging within 28 days before cycle 1 day 1, or CSF cytology positive for lymphoma cells in leptomeningeal disease
- Eastern Cooperative Oncology Group performance status of 0 to 3
- Adequate bone marrow and organ function including ANC ≥ 1.0 x 10^9/L, platelets ≥ 75 x 10^9/L without recent transfusion, hemoglobin ≥ 8 g/dL without recent transfusion
- International Normalized Ratio ≤ 1.5 and PTT ≤ 1.5 times upper limit of normal
- ALT and AST ≤ 2.5 times upper limit of normal
- Serum bilirubin ≤ 1.5 times upper limit of normal or total bilirubin ≤ 3 times upper limit with normal direct bilirubin in Gilbert Syndrome
- Creatinine clearance ≥ 50 ml/min
- Life expectancy greater than 3 months
You will not qualify if you...
- Actively receiving treatment for extra-CNS disease in SCNSL
- Lymphoma with only intraocular involvement
- T-cell lymphoma diagnosis
- Disease progression within 6 months after prior methotrexate regimen
- Only prior stereotactic radiation therapy
- Chemotherapy, monoclonal antibodies, or targeted therapy within 21 days or 5 half-lives before cycle 1 day 1
- Active, unstable cardiovascular diseases including recent myocardial infarction, unstable angina, significant conduction abnormalities, congestive heart failure NYHA grade 3 or higher, or left ventricular ejection fraction below 50%
- Uncontrolled active infection within 1 week before first dose
- Known active hepatitis B, hepatitis C, or HIV infection (except controlled or undetectable viral loads)
- Active gastrointestinal dysfunction that interferes with swallowing or absorption
- Prior exposure to selective inhibitor of nuclear export compounds including Selinexor
- Serious psychiatric or medical conditions that may interfere with treatment per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, China
Not Yet Recruiting
2
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Not Yet Recruiting
3
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, Fujian, China
Not Yet Recruiting
4
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
5
Department of Hematology, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
Research Team
T
Tong Chen, Ph.D
CONTACT
Y
Yuan Yan, Ph.D
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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