Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study
Smart Stop: A Phase II Trial of Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Prior to and With Standard Chemotherapy for Patients With Newly Diagnosed DLBCL
Sponsor: M.D. Anderson Cancer Center
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Overall response rate
Time frame: At the end of 4 cycles of therapy with rituximab, lenalidomide, acalabrutinib, tafasitamab (each cycle = 21 days)
Complete response rate
Time frame: At the end of 10 cycles of therapy with rituximab, lenalidomide, acalabrutinib, tafasitamab and chemotherapy (each cycle = 21 days)
Secondary Endpoints
Incidence of adverse events (AEs)
Progression free survival
Overall survival
Eligibility Criteria
Inclusion Criteria: 1. Histopathologically confirmed diagnosis of DLBCL. 2. No prior treatment except a prior limited-field radiotherapy, a short course of glucocorticoids ≤50mg daily of prednisone equivalent which must be no more than 4 days in duration and cease prior to day 1 of cycle 1, and/or 1 dose of cyclophosphamide 750mg/m2 for an urgent lymphoma related problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome). 3. Age ≥ 18 years and able to provide informed consent. 4. Participants must have bi-dimensional measurable disease, as defined as radiographically apparent disease with the longest dimension of ≥1.5cm. 5. Participants with performance status of ≤3 (3 only allowed if decline in status is deemed related to lymphoma and felt potentially reversible by the treating physician). 6. Serum bilirubin \<1.5x ULN except in participants with Gilbert's syndrome as defined by \> 80% unconjugated bilirubin who must have a serum bilirubin of \<4x ULN; AST (SG…
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