ACP-196 (Acalabrutinib), a Novel Bruton Tyrosine Kinase (BTK) Inhibitor, for Treatment of Chronic Lymphocytic Leukemia, Richter's Syndrome or Prolymphocytic Leukemia

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.”

• Number of Participants With Dose Limiting Toxicities (DLTs) in Phase 1

  Measured over: From Day 1 to Day 28 after first dose of study drug

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

  Measured over: Day 1 through the final data cutoff date (approximately 7 years 6 months)

• Number of Participants With Treatment Emergent Events of Clinical Interest (ECI)

  Measured over: Day 1 through the final data cutoff date (approximately 7 years 6 months)

• Number of Participants With Clinically Important Laboratory Abnormalities With Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or More

  Measured over: Day 1 through the final data cutoff date (approximately 7 years 6 months)

• Number of Participants With Clinically Abnormal Vital Signs Reported as TEAEs

  Measured over: Day 1 through the final data cutoff date (approximately 7 years 6 months)

• Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours (AUC0-6) of Acalabrutinib

  Measured over: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, and 6 hours postdose on Day 1 and Day 8

• Area Under the Plasma Concentration-time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Acalabrutinib

  Measured over: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8

• Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-inf) of Acalabrutinib

  Measured over: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8

• Maximum Observed Plasma Concentration (Cmax) of Acalabrutinib

  Measured over: Predose and at 0.25, 0.5, 0.75, 1, 2, 4, 6, and 24 hours postdose on Day 1 and Day 8

• Time of Maximum Plasma Concentration (Tmax) of Acalabrutinib

Changes Tremor has spotted