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New treatment option for Central Nervous System Lymphoma
Official title Selinexor in Combination With MTX+Ritu to Treat R/R CNSL
ClinicalTrials.gov ID: NCT05698147
What this study is testing
What is Selinexor?
Selinexor is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for central nervous system lymphoma.
Also referred to as ATG-010.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients must meet all of the following to be eligible to enroll in this study:
- Participants must be able to understand and be willing to sign a written informed consent document.
- Men and woman who are 18-75 years old on the day of consenting to the study.
- Histologically documented PCNSL and SCNSL secondary to histologically documented systemic diffuse large B-cell lymphoma (DLBCL).
- Patients must have relapsed/refractory PCNSL or relapsed/refractory SCNSL.
You likely can't join if
- Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded.
- Lymphoma patients with only intraocular involvement.
- Pathological diagnosis of PCNSL is T-cell lymphoma.
- Patients with disease progression within 6 months of prior methotrexate-containing regimen.
- patients only had received stereotactic radiation therapy as prior treatment.
- Patients have received chemotherapy, monoclonal antibodies or targeted anticancer therapy within 21 days or 5 half-lives, whichever is shorter, prior...
See the full eligibility criteria
- Patients must meet all of the following to be eligible to enroll in this study:
- Participants must be able to understand and be willing to sign a written informed consent document.
- Men and woman who are 18-75 years old on the day of consenting to the study.
- Histologically documented PCNSL and SCNSL secondary to histologically documented systemic diffuse large B-cell lymphoma (DLBCL).
- Patients must have relapsed/refractory PCNSL or relapsed/refractory SCNSL.
- Patients must have response or remain stable disease for 2 months to prior methotrexate-based regimen.
- Patients who had prior autologous hematopoietic stem cell transplantation are eligible.
- 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...
- Participants must have an Eastern Cooperative Oncology Group performance status of 0-3.
- Participants must have adequate bone marrow and organ function shown by:
- Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L
- 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...
- International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal.
- 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.
- Calculated creatinine clearance(CrCl)≥50ml/min using the Cockcroft-Gault equation or 24-hour urine collection.
- Life expectancy of \> 3 months.
- Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded.
- Lymphoma patients with only intraocular involvement.
- Pathological diagnosis of PCNSL is T-cell lymphoma.
- Patients with disease progression within 6 months of prior methotrexate-containing regimen.
- patients only had received stereotactic radiation therapy as prior treatment.
- Patients have received chemotherapy, monoclonal antibodies or targeted anticancer therapy within 21 days or 5 half-lives, whichever is shorter, prior to C1D1.
- Patients with active, unstable cardiovascular diseases, fits any of the following:
- myocardial infarction within 6 months prior to the study enrollment
- unstable angina within 3 months prior to the study enrollment
- Uncontrolled clinically-significant conduction abnormalities (e.g., ventricular tachycardia, ventricular fibrillation, etc.)
- Congestive heart failure (CHF) of New York Heart Association (NYHA) ≥ Grade 3
- Echocardiography showing left ventricular ejection fraction less than 50%
- Uncontrolled active infection within 1 week prior to the first dose of study drug.
- 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...
- Active GI dysfunction interfering with the ability to swallow tablets, or any GI dysfunction that could interfere with absorption of study treatment.
- Prior exposure to a selective inhibitor of nuclear export(SINE) compound, including selinexor.
- Serious, active psychiatric, or medical conditions which, in the opinion of the Investigator, could interfere with study treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Hefei, Anhui, China
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Zhengzhou, Henan, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hefei, Anhui, China; Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Zhengzhou, Henan, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.