Trials / Active Not Recruiting
Active Not RecruitingNCT05023980
A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 309 (actual)
- Sponsor
- Loxo Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pirtobrutinib | Oral |
| DRUG | Bendamustine | IV |
| DRUG | Rituximab | IV |
Timeline
- Start date
- 2021-09-23
- Primary completion
- 2025-07-11
- Completion
- 2027-10-01
- First posted
- 2021-08-27
- Last updated
- 2026-01-22
Locations
108 sites across 20 countries: United States, Australia, Austria, Brazil, Bulgaria, China, Czechia, France, Hungary, Italy, Japan, New Zealand, Poland, Portugal, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05023980. Inclusion in this directory is not an endorsement.