NCT05698147 Selinexor in Combination With MTX+Ritu to Treat R/R CNSL
| NCT ID | NCT05698147 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Tong Chen, MD |
| Condition | Central Nervous System Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-08-03 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-08-03 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients must meet all of the following inclusion criteria to be eligible to enroll in this study: 1. Participants must be able to understand and be willing to sign a written informed consent document. 2. Men and woman who are 18-75 years old on the day of consenting to the study. 3. Histologically documented PCNSL and SCNSL secondary to histologically documented systemic diffuse large B-cell lymphoma (DLBCL). 4. Patients must have relapsed/refractory PCNSL or relapsed/refractory SCNSL. 5. Patients must have response or remain stable disease for 2 months to prior methotrexate-based regimen. 6. Patients who had prior autologous hematopoietic stem cell transplantation are eligible. 7. Patients with parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) 28 days prior to cycle1 day 1(C1D1). For patients with leptomeningeal disease only, CSF cytology must document lymphoma cells. 8. Participants must have an Eastern Cooperative Oncology Group performance status of 0-3. 9. Participants must have adequate bone marrow and organ function shown by: 1. Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L 2. Platelets ≥ 75 x 10\^9/L and no platelet transfusion within the past 14 days prior to study registration c Hemoglobin (Hgb) ≥ 8 g/dL and no red blood cell (RBC) transfusion within the past 14 days prior to study registration 10. International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal. 11. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal. 12. Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome. 13. Calculated creatinine clearance(CrCl)≥50ml/min using the Cockcroft-Gault equation or 24-hour urine collection. 14. Life expectancy of \> 3 months. Exclusion Criteria: 1. Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded. 2. Lymphoma patients with only intraocular involvement. 3. Pathological diagnosis of PCNSL is T-cell lymphoma. 4. Patients with disease progression within 6 months of prior methotrexate-containing regimen. 5. patients only had received stereotactic radiation therapy as prior treatment. 6. Patients have received chemotherapy, monoclonal antibodies or targeted anticancer therapy within 21 days or 5 half-lives, whichever is shorter, prior to C1D1. 7. Patients with active, unstable cardiovascular diseases, fits any of the following: 1. myocardial infarction within 6 months prior to the study enrollment 2. unstable angina within 3 months prior to the study enrollment 3. Uncontrolled clinically-significant conduction abnormalities (e.g., ventricular tachycardia, ventricular fibrillation, etc.) 4. Congestive heart failure (CHF) of New York Heart Association (NYHA) ≥ Grade 3 5. Echocardiography showing left ventricular ejection fraction less than 50% 8. Uncontrolled active infection within 1 week prior to the first dose of study drug. 9. Known active hepatitis B, or C infection or HIV infection; Note: Hepatitis B virus (HBV) surface antigen (HBsAg) and or hepatitis B core antibody-positive but undetectable HBV DNA or Hepatitis C virus (HCV) antibody positive but hepatitis C virus RNA undetectable are allowed. 10. Active GI dysfunction interfering with the ability to swallow tablets, or any GI dysfunction that could interfere with absorption of study treatment. 11. Prior exposure to a selective inhibitor of nuclear export(SINE) compound, including selinexor. 12. Serious, active psychiatric, or medical conditions which, in the opinion of the Investigator, could interfere with study treatment.
Contact & Investigator
Tong Chen, Ph.D
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT05698147 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Central Nervous System Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05698147 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05698147 currently recruiting?
Yes, NCT05698147 is actively recruiting participants. Contact the research team at chentong@fudan.edu.cn for enrollment information.
Where is the NCT05698147 trial being conducted?
This trial is being conducted at Hefei, China, Beijing, China, Fuzhou, China, Zhengzhou, China and 1 additional location.
Who is sponsoring the NCT05698147 clinical trial?
NCT05698147 is sponsored by Tong Chen, MD. The principal investigator is Tong Chen, Ph.D at Huashan Hospital. The trial plans to enroll 30 participants.