A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Part of paid clinical trials in Los Angeles, California.

Sponsor
Loxo Oncology, Inc.
Study ID
NCT05023980
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pirtobrutinib — DRUG
    Oral
  • Bendamustine — DRUG
    IV
  • Rituximab — DRUG
    IV

Study Details

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.

Key Dates

Start date
Sep 23, 2021
Status verified
Jan 2026
Primary completion
Jul 11, 2025
Completion
Oct 31, 2027

Study Design

Enrollment
309 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (Pirtobrutinib)
    Pirtobrutinib administered orally
  • Active Comparator: Arm B (BR)
    Bendamustine plus rituximab administered intravenously (IV)

Primary Outcome Measure

To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B) [ Time Frame: Up to approximately 5 years ]

Locations (5)

FacilityCityStateZIPSite coordinators
California Research InstituteLos AngelesCalifornia90027-
Innovative Clinical Research InstituteWhittierCalifornia90603-
Oncology-Hematology Associates of West BrowardCoral SpringsFlorida33065-
New Jersey Center for Cancer ResearchBrickNew Jersey08724-
Clinical Research Alliance, Inc.WestburyNew York11590-

Find similar trials in Los Angeles, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
California Research Institute· Los Angeles, CAInnovative Clinical Research Institute· Whittier, CAOncology-Hematology Associates of West Broward· Coral Springs, FLNew Jersey Center for Cancer Research· Brick, NJClinical Research Alliance, Inc.· Westbury, NY

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