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 range18 Years – 70 Years
SexALL
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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.
✓. 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.
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)
✕. 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;