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A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

NCT04965493 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-01-29

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

Conditions

Interventions

DRUG

Pirtobrutinib

Oral

DRUG

Venetoclax

Oral

DRUG

Rituximab

Intravenous (IV)

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2026-10-31
Completion
2027-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • Czechia
  • Denmark
  • France
  • Germany
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Norway
  • Poland
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04965493 on ClinicalTrials.gov