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)

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Loxo Oncology, Inc.
Study ID
NCT04965493
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

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.

Key Dates

Start date
Sep 20, 2021
Status verified
Jan 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2027

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (PVR)
    Fixed duration pirtobrutinib in combination with venetoclax and rituximab
  • Active Comparator: Arm B (VR)
    Venetoclax with rituximab

Primary Outcome Measure

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

Locations (41)

FacilityCityStateZIPSite coordinators
Ironwood Physicians, Ironwood Cancer and Research CentersChandlerArizona85224-
Mayo Clinic HospitalPhoenixArizona85054-
University of California Irvine Medical CenterOrangeCalifornia92868-
Scripps Mercy HospitalSan DiegoCalifornia92111-
Providence Medical FoundationSanta RosaCalifornia95403-
Stamford HospitalStamfordConnecticut06902-
Florida Cancer SpecialistsFort MyersFlorida33916-2233-
Cancer Specialists of North Florida -St AugustineSaint AugustineFlorida32086-
Florida Cancer Specialists EastWest Palm BeachFlorida33401-
Mission Cancer and BloodDes MoinesIowa50309-
Pikeville Medical Center, Inc.PikevilleKentucky41501-
American Oncology Partners of Maryland, PABethesdaMaryland20817-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
St. Joseph Mercy HospitalAnn ArborMichigan48106-
University of MichiganAnn ArborMichigan48109-
Mayo ClinicRochesterMinnesota55905-0002-
Research Medical CenterKansas CityMissouri64132-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
Columbia University Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
The Mount Sinai HospitalNew YorkNew York10029-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Novant Cancer Institute CharlotteCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27710-
Regional Medical Oncology CenterWilsonNorth Carolina27893-
Oncology Hematology Care IncCincinnatiOhio45242-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
The James Cancer HospitalColumbusOhio43210-
Oncology Associates of Bridgeport P.C.EugeneOregon97401-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Sarah Cannon Research Institute SCRINashvilleTennessee37203-
Tennessee Oncology PLLCNashvilleTennessee37203-
Texas Oncology-Baylor Charles A. Sammons Cancer CenterDallasTexas75246-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-
USO - Texas Oncology - San AntonioSan AntonioTexas78240-
University of Virginia Health SystemCharlottesvilleVirginia22908-0816-
Virginia Cancer Specialists, PC - Lee HighwayFairfaxVirginia22031-
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298-0070-
Fred Hutchinson Cancer Research CenterSeattleWashington98104-2092-
Swedish Cancer Institute; STE 1020SeattleWashington98104-
Northwest Cancer Specialists PCVancouverWashington98684-

Find similar trials in Chandler, AZ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Ironwood Physicians, Ironwood Cancer and Research Centers· Chandler, AZMayo Clinic Hospital· Phoenix, AZUniversity of California Irvine Medical Center· Orange, CAScripps Mercy Hospital· San Diego, CAProvidence Medical Foundation· Santa Rosa, CAStamford Hospital· Stamford, CT

Related Studies