SPEL as Introductive Treatment Following Immune-chemotherapy as Consolidated Therapy for R/R DLBC… (NCT05498636) | Clinical Trial Compass
UnknownPhase 1/2
SPEL as Introductive Treatment Following Immune-chemotherapy as Consolidated Therapy for R/R DLBCL With p53 and/or c-Myc Expression
China67 participantsStarted 2022-10-01
Plain-language summary
This study is a phase II multi-center prospective clinical trail which investigates the efficacy and safety of Selinexor combined with prednisone, etoposide and lenalidomide in the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patient with high p53 and/or c-myc expression.
Who can participate
Age range16 Years – 80 Years
SexALL
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Inclusion criteria
✓. Any of the following as defined by the WHO, 2016 lymphoid neoplasm classifications and histologically confirmed：Diffuse large B-cell lymphoma with p53 and/ or c-Myc protein overexpression.
✓. Patients who cannot tolerate or are unwilling to undergo intensive salvage therapy due to age or frailty; patients who have received at most three prior lines of regimen, in which stem cell transplantation is considered first-line.
✓. With a life expectancy of ≥ 3 months
✓. Age ≥ 18 years
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
✓. At least 1 evaluable or measurable lesion that meets Lugano2014 criteria \[Evaluable lesions: PET/CT examination showed increased uptake in lymph nodes or extranodal areas (higher than that in the liver), and pet/ct features were consistent with lymphoma. Measurable disease: Nodular lesions with longest diameter (LDi) greater than \> 15mm or extranodal lesion with LDi \>10mm. and FDG-PET positive lesions\]
✓. All screening laboratory tests should be performed according to the protocol and within 14 days before enrollment. Screening laboratory values must meet the following criteria： Routine blood tests (no blood transfusion, no G-CSF, no drug correction within 14 days before screening) : a. Hb≥80g/L；b.ANC≥1.0×109/L；c.PLT≥75×109/L.
✓. Written informed consent of the patient
Exclusion criteria
✕. Patient with hemophagocytic syndrome
✕
What they're measuring
1
CR rate
Timeframe: At the end of Cycle 4 (each cycle is 28 days)
2
ORR
Timeframe: At the end of Cycle 4 (each cycle is 28 days)
Trial details
NCT IDNCT05498636
SponsorThe Affiliated Hospital of Qingdao University