A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Loxo Oncology, Inc.
Study ID
NCT06588478
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Pirtobrutinib — DRUG
    Administered Orally.

Study Details

The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.

Key Dates

Start date
Jan 3, 2025
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

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

Arms

  • Active Comparator: Pirtobrutinib Standard Dose (Dose 1)-Part 1
    Pirtobrutinib administered orally.
  • Experimental: Pirtobrutinib Dose 2-Part 1
    Pirtobrutinib administered orally.
  • Experimental: Pirtobrutinib Dose 3-Part 1
    Pirtobrutinib administered orally.
  • Experimental: Pirtobrutinib Standard Dose-Part 2
    Pirtobrutinib administered orally.

Primary Outcome Measure

Overall Response Rate [ Time Frame: Baseline up to 3 years ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

Locations (21)

FacilityCityStateZIPSite coordinators
Ironwood Cancer & Research CentersChandlerArizona85224
Michael Musci (PRINCIPAL_INVESTIGATOR)
City of Hope National Medical CenterDuarteCalifornia91010
800-826-4673
Alexey Danilov (PRINCIPAL_INVESTIGATOR)
City of Hope National Medical CenterIrvineCalifornia92618
626-218-2405
Alexey Danilov (PRINCIPAL_INVESTIGATOR)
Palo Alto Medical Foundation Research Institute (PAMFRI)Palo AltoCalifornia94304
Roozbeh Mohajer (PRINCIPAL_INVESTIGATOR)
Stanford Cancer CenterPalo AltoCalifornia94304
Bita Fakhri (PRINCIPAL_INVESTIGATOR)
Rocky Mountain Cancer CenterAuroraColorado80012
303-418-7639
John Burke (PRINCIPAL_INVESTIGATOR)
University of Miami Hospital and Clinics, Sylvester Cancer CenterMiamiFlorida33136
Alvaro Alencar (PRINCIPAL_INVESTIGATOR)
City of Hope National Medical Center, Atlanta Cancer CenterNewnanGeorgia30265
Sabarish Ayyappan (PRINCIPAL_INVESTIGATOR)
Mission Cancer + BloodWaukeeIowa50263
515-282-2921
Tara Graff (PRINCIPAL_INVESTIGATOR)
Saint Elizabeth Medical Center EdgewoodEdgewoodKentucky41017
Miguel Islas-Ohlmayer (PRINCIPAL_INVESTIGATOR)
American Oncology Partners, PABethesdaMaryland20817
301-571-2016
Victor Priego (PRINCIPAL_INVESTIGATOR)
Boston Medical CenterBostonMassachusetts02118
Andrew Wilks (PRINCIPAL_INVESTIGATOR)
Gulfport Memorial HospitalGulfportMississippi39501
228-575-1234
Pamela Tuli (PRINCIPAL_INVESTIGATOR)
Comprehensive Cancer Centers of NevadaHendersonNevada89074
Anthony Nguyen (PRINCIPAL_INVESTIGATOR)
East Carolina UniversityGreenvilleNorth Carolina27834
252-744-1015
Darla Liles (PRINCIPAL_INVESTIGATOR)
Williamette Valley Cancer Institute & Research CenterEugeneOregon97401
541-683-5001
Jeff Sharman (PRINCIPAL_INVESTIGATOR)
Cancer Care Associates Of YorkYorkPennsylvania17403
717-741-9229
Jackson Gao (PRINCIPAL_INVESTIGATOR)
The West Clinic, PLLC dba West Cancer CenterGermantownTennessee38138
901-683-0055
Jason Chandler (PRINCIPAL_INVESTIGATOR)
USO-Texas Oncology-Central/South TexasAustinTexas78705
512-421-4100
Jason Melear (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research Institute/SCRIThe WoodlandsTexas77380
999-999-9999
SMO Sarah Cannon Research Inst. (PRINCIPAL_INVESTIGATOR)
USO-Virginia Oncology AssociatesHamptonVirginia23666
757-368-0437
Celesteann Bremer (PRINCIPAL_INVESTIGATOR)

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