Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of N… (NCT07072208) | Clinical Trial Compass
RecruitingNot Applicable
Pomalidomide, Rituximab and Orelabrutinib Combined With Polatuzumab Vedotin in the Treatment of Newly Diagnosed Elderly Patients With DLBCL
China43 participantsStarted 2024-11-01
Plain-language summary
To evaluate the efficacy and safety of the Pro-Pola （Pomalidomide, rituximab, orelabrutinib and polatuzumab vedotin) regimen in elderly patients (aged ≥70 years) with newly diagnosed diffuse large B-cell lymphoma (DLBCL).
Who can participate
Age range70 Years
SexALL
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Inclusion criteria
✓. Age ≥70 years unfit or frail
✓. There is at least one image-measurable lesion with a measurable lesion of at least 15 mm.
✓. appropriate organ function: Cardiac function: Cardiac ejection fraction ≥50%; Liver function: alanine aminotransferase and aspartate aminotransferase ≤3 times the upper limit of normal; Renal function: Serum creatinine clearance ≥30mL/min; Lung function: SPO2 \>90% without oxygen inhalation
✓. Adequate bone marrow reserve is defined as:
✓. Patients have the ability to understand and are willing to provide written informed consent.
✓. Subjects with childbearing or childbearing potential must be willing to practice birth control from the date of registration in this study to the follow-up period of the study.
Exclusion criteria
✕. Severe abnormal liver and kidney function (alanine aminotransferase, bilirubin, creatinine\>3 times the upper limit of normal);
✕. Presence of organic heart disease or severe arrhythmia leading to clinical symptoms or abnormal cardiac function (NYHA Functional Class Grade ≥2);
✕. Uncontrolled active infection;
✕
What they're measuring
1
Complete response rate(CRR)
Timeframe: At the end of 6 cycles of Pro-pola regimen (each cycle is 21 days)
Trial details
NCT IDNCT07072208
SponsorThe First Affiliated Hospital of Soochow University