NOTE

🌱 created from: double_hit_and_double_expressors_in_lymphoma

smart_stop

Smart Stop: Lenalidomide, Tafasitamab, Rituximab, and Acalabrutinib Alone and with Combination Chemotherapy for the Treatment of Newly Diagnosed Diffuse Large B-Cell Lymphoma

• Design: Phase 2, open-label, single-arm trial
• Number of patients: 30 (Cohort 1)
• Patients characteristics: Patients 18 years or older with previously untreated diffuse large B-cell lymphoma (DLBCL)
• Agent: Lenalidomide, tafasitamab, rituximab, and acalabrutinib (LTRA) with or without CHOP therapy
• Treatment line: First-line therapy
• Trial Name or NCT Number: Smart Stop trial (NCT04978584)

Results

• Endpoints
  • 1A: Overall Response Rate (ORR) after 4 cycles of LTRA
  • 1B: Complete Response Rate (CRR) at the end of therapy
• Interim results
  • ORR after 4 cycles of LTRA: 100%
  • CRR after 4 cycles of LTRA: 64%
  • CRR at the end of therapy: 100%

Other findings

• 47% of patients experienced rash (13% grade 3)
• 40% of patients required a dose reduction of lenalidomide
• No patients have progressive lymphoma, including the first 6 patients with 3 and 6 month follow-up scans

Summary The Smart Stop trial demonstrates that the combination of lenalidomide, tafasitamab, rituximab, and acalabrutinib is highly effective as an initial chemotherapy-free combination in patients with newly diagnosed DLBCL, and may allow for a response-adapted reduction in chemotherapy.