A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT07218341
Phase
PHASE4
Status
Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Pirtobrutinib — DRUG
    Administered orally
  • Idelalisib — DRUG
    Administered orally

Study Details

This study will evaluate the long-term safety of pirtobrutinib in participants with previously treated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study is open to those who completed J2N-MC-JZNN/LOXO-BTK-20020 (NCT 04666038) for continued access to the study intervention or continued follow-up visits. Treatment will be given every 4 weeks and this study is expected to last about 5 years.

Key Dates

Start date
Mar 9, 2026
Status verified
May 2026
Primary completion
May 31, 2030
Completion
Dec 31, 2032

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pirtobrutinib (Arm A)
    Participants receive pirtobrutinib orally
  • Experimental: Idelalisib (Arm B)
    Participants receive idelalisib orally

Primary Outcome Measure

Percentage of Participants with a Grade 3 or Higher Treatment-emergent Adverse Events (AEs) [ Time Frame: Time from First Dose of Study Intervention (Study Day 1) through 30 Days After Last Dose of Study Intervention or Start of New Anticancer Therapy, whichever is Earlier ]

Central Contacts

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

Locations (9)

FacilityCityStateZIPSite coordinators
Mitchell Cancer InstituteMobileAlabama36693
334-660-5108
Anita Mazloom (PRINCIPAL_INVESTIGATOR)
Arizona Oncology Associates, P.C. - HOPETucsonArizona85711
520-886-0206
Sudhir Manda (PRINCIPAL_INVESTIGATOR)
Cancer Specialists, LLCJacksonvilleFlorida32256
904-538-4488
Ayed Ayed (PRINCIPAL_INVESTIGATOR)
Minnesota Oncology Hematology, P.A.Coon RapidsMinnesota55433
612-884-6300
Avina Singh (PRINCIPAL_INVESTIGATOR)
Cayuga Cancer CenterIthacaNew York14850
Cynthia Davis (PRINCIPAL_INVESTIGATOR)
Memorial Sloan-Kettering Cancer Center (MSKCC) - New YorkNew YorkNew York10065-6007
646-608-4273
Prioty Islam (PRINCIPAL_INVESTIGATOR)
Oncology Hematology Care IncCincinnatiOhio45211
513-751-2273
Kruti Patel (PRINCIPAL_INVESTIGATOR)
Texas Oncology - ParisFort WorthTexas76104
214-370-1000
Harris Naina (PRINCIPAL_INVESTIGATOR)
US Oncology - Texas OncologyKyleTexas78640
210-595-5300
David Friedman (PRINCIPAL_INVESTIGATOR)

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