Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia

Conditions

• Untreated Chronic Lymphocytic Leukemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Acalabrutinib — DRUG
  acalabrutinib 100 mg twice daily orally
• Rituximab — DRUG
  Rituximab: 375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6)
• Chlorambucil — DRUG
  Chlorambucil: 0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6

Study Details

This is a randomized, multicenter, open-label, Phase 3 study to evaluate the efficacy and safety of Acalabrutinib versus Chlorambucil plus Rituximab in subjects with Previously Untreated Chronic Lymphocytic Leukemia.

Key Dates

Start date

Jan 20, 2020

Status verified

Jun 2026

Primary completion

Jan 3, 2024

Completion

Jan 1, 2027

Study Design

Enrollment

155 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Acalabrutinib
  Acalabrutinib will be orally administered until disease progression or unacceptable toxicity
• Active Comparator: Rituximab and Chlorambucil
  Chlorambucil orally administered and Rituximab via IV infusion for 6 cycles

Primary Outcome Measure

Progression Free Survival (PFS) Assessed by BICR [ Time Frame: Response evaluations performed every 12 weeks from Cycle 4 Day 1 to Cycle 25, then every 24 weeks until PD or death, up to DCO date of 03 January 2024 (a maximum of approximately 47.5 months) ]