Status:
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
Lead Sponsor:
Second Affiliated Hospital of Soochow University
Conditions:
Lymphomas
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 transpl...
Detailed Description
This is a prospective, investigator-initiated, open-label, single-arm, multicenter phase II clinical trial designed to evaluate the efficacy and safety of a combination regimen consisting of selinexor...
Eligibility Criteria
Inclusion
- Age ≥ 18 years, male or female.
- Histologically confirmed primary CNS lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL) with CNS-only involvement.
- Ineligible for autologous stem cell transplantation based on clinical assessment or patient refusal.
- At least one measurable brain lesion ≥1 cm in diameter, or positive cerebrospinal fluid (CSF) cytology/flow cytometry for patients with leptomeningeal disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.
- Adequate organ function, including:
- Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L
- Platelets ≥ 75 × 10⁹/L
- Hemoglobin ≥ 80 g/L
- Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN if liver involvement)
- ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN if liver involvement)
- Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula)
- INR ≤ 1.5 × ULN; APTT within 10 seconds of normal
- Estimated life expectancy of ≥ 3 months.
- Negative serum pregnancy test for women of childbearing potential.
- Ability to understand and willingness to sign a written informed consent form.
Exclusion
- CNS involvement limited to intraocular lymphoma only.
- Prior systemic therapy for CNS lymphoma.
- SCNSL with active systemic (non-CNS) disease involvement.
- Uncontrolled intracranial hypertension.
- Clinically significant or unstable cardiovascular disease, including:
- Myocardial infarction within 6 months
- Unstable angina within 3 months
- Uncontrolled arrhythmias (e.g., ventricular tachycardia/fibrillation)
- Congestive heart failure NYHA class ≥ III
- LVEF \< 50% by echocardiography
- Other severe uncontrolled medical conditions, including active infections requiring systemic therapy.
- Known active hepatitis B (HBV), hepatitis C (HCV), or HIV infection.
- Active gastrointestinal dysfunction that interferes with the ability to swallow or absorb oral medication.
- Prior treatment with selective inhibitor of nuclear export (SINE) compounds, including selinexor.
- Concurrent malignancy, except for adequately treated basal/squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the cervix, prostate, or breast.
- Pregnant or breastfeeding women, or subjects unwilling to use medically accepted effective contraception during the study and for 6 months after the last dose.
- Any condition which, in the investigator's judgment, would make the patient unsuitable for study participation.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT07002099
Start Date
June 1 2025
End Date
December 31 2028
Last Update
June 3 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Second Affiliated Hospital of Soochow University
Suzhou, China, 215000