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NCT05023980 · ClinicalTrials.gov registry record · Phase 3
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 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, sponsored by Loxo Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 309
- Enrollment target
- 20
- Study locations
NCT05023980 is a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma that is active but no longer recruiting, run by Loxo Oncology. The registered enrollment target is 309 participants, above the 180-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (72% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT05023980, a Phase 3 study of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, is active but no longer recruiting, sponsored by Loxo Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 309 participants
- Enrollment target
- 20
- Study locations
Study 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 Studied
Interventions
- DRUG Rituximab
- DRUG Pirtobrutinib
- DRUG Bendamustine
Study Locations (20)
Other
- Uniklinikum Salzburg - Salzburg
- Klinik Ottakring - Vienna
- UMHAT "Sveti Georgi" EAD - Plovdiv
- UMHAT 'Sv. Ivan Rilski', EAD - Sofia
- "SHATHD" EAD, Sofia - Sofia
- UMHAT - Prof. Dr. Stoyan Kirkovich" AD - Stara Zagora
Rio Grande do Sul
- Hospital de Clinicas de Porto Alegre - Porto Alegre
- Irmandade da Santa Casa de Misericórdia de Porto Alegre - Porto Alegre
- Centro Gaucho Integrado - Mae de Deus Center - Porto Alegre
California
- California Research Institute - Los Angeles
- Innovative Clinical Research Institute - Whittier
New South Wales
- Liverpool Hospital - Liverpool
- Westmead Hospital - Wentworthville
São Paulo
- Hemocentro Unicamp - Campinas
- Fundação Doutor Amaral Carvalho - Jaú
Florida
- Oncology-Hematology Associates of West Broward - Coral Springs
New Jersey
- New Jersey Center for Cancer Research - Brick
New York
- Clinical Research Alliance, Inc. - Westbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2021-09-23 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05023980
The ClinicalTrials.gov registry entry for NCT05023980 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 180-participant average among 187 other Chronic Lymphocytic Leukemia trials with a reported enrollment target (72% higher). The listed sponsor is Loxo Oncology, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions - of which Rituximab is the first listed.
NCT05023980 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, Rio Grande do Sul, California.
Frequently Asked Questions
What is clinical trial NCT05023980 about?
NCT05023980 is a clinical study titled "A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)". 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.
What is the current status of trial NCT05023980?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2021-09-23. Estimated completion is 2027-10.
What conditions does trial NCT05023980 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma.
What interventions are being tested in trial NCT05023980?
The interventions under investigation include: Rituximab (DRUG), Pirtobrutinib (DRUG), Bendamustine (DRUG).
Who is sponsoring clinical trial NCT05023980?
This trial is sponsored by Loxo Oncology, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05023980 being conducted?
This trial has 20 study locations across California, Florida, New Jersey, New York, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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