Trials / Active Not Recruiting
Active Not RecruitingNCT04666038
Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 238 (actual)
- Sponsor
- Loxo Oncology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.
Detailed description
This is a Phase 3 global, randomized, open-label study comparing LOXO-305 (Arm A) to investigator's choice of either idelalisib plus rituximab or bendamustine plus rituximab (Arm B) in CLL/SLL patients who have been treated with at least a covalent BTK inhibitor (BTKi). Patients may have discontinued the prior covalent BTKi due to disease progression (PD) or intolerance. Patients who have received venetoclax are eligible for the study. Eligible patients will be randomized in 1:1 to Arm A or Arm B.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pirtobrutinib | Oral Pirtobrutinib |
| DRUG | Idelalisib | Oral |
| DRUG | Bendamustine | IV |
| DRUG | Rituximab | IV |
Timeline
- Start date
- 2021-03-09
- Primary completion
- 2023-08-29
- Completion
- 2027-05-01
- First posted
- 2020-12-14
- Last updated
- 2025-04-20
- Results posted
- 2025-03-07
Locations
232 sites across 24 countries: United States, Australia, Austria, Belgium, Canada, China, Croatia, Czechia, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Poland, Russia, Singapore, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04666038. Inclusion in this directory is not an endorsement.