Orelabrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Ho… (NCT05097443) | Clinical Trial Compass
UnknownPhase 3
Orelabrutinib, Rituximab and Combination Chemotherapy in Newly-diagnosed Aggressive B-cell Non-Hodgkin Lymphoma
China130 participantsStarted 2021-04-15
Plain-language summary
B-cell non-Hodgkin's lymphoma (B-NHL) is the most common type of NHL. Although novel immunotherapies represented by anti-CD20 monoclonal antibodies and CAR-T cell therapies have significantly improved the prognosis of B-NHL patients, there are still nearly one-third of patients who are resistant to initial treatment or relapse after remission. R-CHOP combined with novel drugs was expected to improve the prognosis. Therefore, this study aimed to investigate the potential of Orelabrutinib combined with Rituximab and chemotherapy.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years, gender not limited
✓. Newly and histologically diagnosed aggressive B-NHL
✓. Patients who have not received systematic chemotherapy or immunotherapy;
✓. Patients with at least ≥1 tumor foci with a measurable maximum axis exceeding 1.5 cm;
✓. Eastern cancer collaboration group(ECOG) physical status score: 0-2
✓. Major organ functions meet the following criteria:
✓. Blood routine: (independent of growth factor support or transfusion within 7 days of study entry) neutrophils absolute value ≥1.5×109/L, platelets ≥75×109/L,
✓. Coagulation function：INR and APTT ≤2.5 times ULN，
Exclusion criteria
✕. Current or previous malignancy, unless radical therapy has been performed and there is no evidence of recurrence or metastasis in the past 5 years；
What they're measuring
1
ORR
Timeframe: At the end of Cycle 6 (each cycle is 21 days)
. Patients scheduled for major surgery(examination for diagnostic purposes) within 4 weeks or participating in drug/device clinical trials;
✕. Prior or concurrent indolent B-cell lymphoma transformation;
✕. Have uncontrolled or significant cardiovascular disease, including:
✕. New York Heart Association (NYHA) Grade II or higher congestive heart failure, unstable angina, and myocardial infarction occurred within 6 months before the first administration of the study drug or arrhythmia needing treatment at the time of screening, LVEF \<50%；
✕. Primary cardiomyopathy (such as dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy)；
✕. Clinically significant QTc interval prolongation history, or QTc interval \>470ms for female and \>450ms for male in the screening period；
✕. Symptomatic coronary heart disease patients or needing treatment;