Selinexor in Combination With R-CHOP Followed by Selinexor Maintenance for Untreated EBV-positive… (NCT05577364) | Clinical Trial Compass
UnknownPhase 1/2
Selinexor in Combination With R-CHOP Followed by Selinexor Maintenance for Untreated EBV-positive DLBCL Patients
China54 participantsStarted 2022-11-01
Plain-language summary
This is a prospective, single-arm, multi-center, phase Ib/II clinical trial to evaluate the safety, tolerability, and efficacy of selinexor in combination with R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) followed by selinexor maintenance for untreated EBV-positive diffuse large B-cell lymphoma (DLBCL) patients.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects fully understand and voluntarily participate in this study and sign informed consent
. Age ≥18, ≤70 years, no gender limitation.
. Histologically confirmed diagnosis of EBV-positive diffuse large B-cell lymphoma (DLBCL) (more than 50% of tumor cells are positive with EBV encoded small RNAs (EBERs) in situ hybridization were considered EBERs positive).
. Untreated patients, except for the short-time use of prednisone for controlling tumor-induced symptoms (no more than 30mg/d (or other equivalent amounts of other glucocorticoids), no more than 7 days).
. There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma: measurable lesion: Positron emission tomography/computed tomography (PET/CT) or CT and/or MRI, intranodal lesions with long diameter \>1.5cm, and short diameter \>1.0cm, or extranodal lesions with long diameter \> 1.0 cm.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum tolerated dose (MTD)
Timeframe: The first cycle of selinexor in combination with R-CHOP regimen (21 days)
2
Recommended Phase II Dose (RP2D)
Timeframe: The first cycle of selinexor in combination with R-CHOP regimen (21 days)
. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
. Expected survival ≥ 3 months.
. Adequate function of bone marrow:
Exclusion criteria
. EBV-positive DLBCL combined with other types of lymphoma. Transformed DLBCL.
. EBV-positive DLBCL with central nervous system invasion.
. The patients had previously received XPO1 inhibitors, such as selinexor and so on.
. The patients have contraindications to any drug in the combined treatment.
. The major surgery is performed within 4 weeks before enrollment, except for diagnosis.
. There are any life-threatening diseases, medical conditions or organ system dysfunction that the investigator believes may affect the safety or compliance of patients.
. Heart function and disease meet one of the following conditions:
. Heart failure with the classification of New York Heart Association heart function of grade II;