BridgeMD
Tests treatment safety and results for Lymphoma Cns
Official title A Clinical Study on the Efficacy and Safety of Methotrexate (MTX) or Thiotepa (for MTX Intolerance) or Temozolomide (TMZ) Combined With Orelabrutinib and Selinexor in Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma（SELINA）
ClinicalTrials.gov ID: NCT07191431
What this study is testing
What is Selinexor+Orelabrutinib+Methotrexate/Thiotepa/Temozolomide?
Selinexor+Orelabrutinib+Methotrexate/Thiotepa/Temozolomide is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for lymphoma cns.
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
- Clinical Study on the Efficacy and Safety of Methotrexate (MTX) or Thiotepa (for MTX intolerance) or Temozolomide (TMZ) Combined with Orelabrutinib and Selinexor in the Treatment of Relapsed/Refractory Primary or Secondary Central Nervous System Lymphoma This study adopts an open-label, prospective, single-arm, single-center design aimed at evaluating the efficacy and safety of methotrexate (MTX) or thiotepa (for MTX intolerance) or temozolomide (TMZ) combined with orelabrutinib and selinexor in the treatment of relapsed/refractory primary or secondary central nervous system lymphoma (r/r CNSL). Primary Objective To evaluate the efficacy and safety of methotrexate (MTX) or thiotepa (for MTX intolerance) or temozolomide (TMZ) combined with orelabrutinib and selinexor in the treatment of relapsed/refractory primary or secondary central nervous system lymphoma (r/r CNSL).
- Time commitment: about 3 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 80
You may be able to join if
- Patients must meet all of the following criteria to be enrolled in this study:
- Fully understand this study and voluntarily sign the informed consent form;
- Age: 14-80 years;
- Life expectancy judged by the investigator to exceed 3 months;
- B-cell origin central nervous system lymphoma (CNSL) confirmed by pathology or flow cytometry (histology or cytology);
You likely can't join if
- Patients who meet any of the following criteria will not be allowed to enter this study:
- Contraindication to any drug in the treatment regimen;
- Subject has a history of active liver disease, including viral or other hepatitis or cirrhosis (Hepatitis B defined as HBV-DNA above the upper limit...
- Human Immunodeficiency Virus (HIV) infection;
- Congestive heart failure (New York Heart Association Class \>2); history of acute myocardial infarction, unstable angina, stroke, or transient...
- Hereditary long QT syndrome or QTc \>480ms (Note: QTc interval must be calculated using Fridericia's formula, QTcF = QT/(RR)\^0.33);
See the full eligibility criteria
- Patients must meet all of the following criteria to be enrolled in this study:
- Fully understand this study and voluntarily sign the informed consent form;
- Age: 14-80 years;
- Life expectancy judged by the investigator to exceed 3 months;
- B-cell origin central nervous system lymphoma (CNSL) confirmed by pathology or flow cytometry (histology or cytology);
- Relapsed or refractory PCNSL or SCNSL: Must have received at least one prior systemic therapy for CNS lesions; number of relapses is not restricted;
- Any non-hematological toxicity related to prior treatment should have recovered to Grade 1 or normal (according to NCI CTCAE version 5.0, except alopecia).
- Bone marrow and organ function meeting the following criteria (no transfusion, no G-CSF use, no medication for correction within 14 days before screening): Bone marrow function: Absolute neutrophil count ≥1.0x10⁹/L...
- Female people of childbearing potential and male people with reproductive ability, who have no pregnancy plan with their partners during the study period and for 3 months after treatment interruption, must use one of...
- Good compliance, willing to adhere to the visit schedule, dosing plan, laboratory tests, and other trial procedures.
- Patients who meet any of the following criteria will not be allowed to enter this study:
- Contraindication to any drug in the treatment regimen;
- Subject has a history of active liver disease, including viral or other hepatitis or cirrhosis (Hepatitis B defined as HBV-DNA above the upper limit of normal; active Hepatitis C defined as seropositive for HCV...
- Human Immunodeficiency Virus (HIV) infection;
- Congestive heart failure (New York Heart Association Class \>2); history of acute myocardial infarction, unstable angina, stroke, or transient ischemic attack within the past six months;
- Hereditary long QT syndrome or QTc \>480ms (Note: QTc interval must be calculated using Fridericia's formula, QTcF = QT/(RR)\^0.33);
- Pregnant and lactating women, or those planning to become pregnant during the study period;
- Clear history of neurological or psychiatric disorders, or history of psychotropic drug abuse or drug addiction;
- Clinically significant active infection.
The study team makes the final eligibility decision.
Where it's taking place
- 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 study runs about 3 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include 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.