Study of Sonrotoclax (BGB-11417) Monotherapy in Participants With Relapsed or Refractory Mantle Cell Lymphoma

No strong warning signs right now. The score counts warning signs; it is not a prediction.

Why this score

Score over time

What counts as success

The trial's main goal(s), called the “primary outcome.”

• Part 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)

  Measured over: From first dose in the ramp-up period through the first 3 weeks of treatment at the target dose (approximately 7 weeks)

• Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events Leading to Treatment Discontinuation

  Measured over: From first dose of study drug up to 30 days after last dose or the primary analysis data cut-off date, whichever occurred earlier; maximum duration of treatment was 31 months.

• Part 1: Number of Participants Experiencing Tumor Lysis Syndrome (TLS) Adverse Events

  Measured over: From first dose of study drug up to 30 days after last dose or the primary analysis data cut-off date, whichever occurred earlier; maximum duration of treatment was 31 months.

• Part 2: Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC)

  Measured over: Response was assessed 8 and 16 weeks after the first dose, then every 12 weeks up to 1 year, every 24 weeks for 2 years, and yearly thereafter; median (range) time on follow-up in efficacy-evaluable participants in Part 2 was 14.2 (0.3-24.9) months.

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