Active — Not RecruitingPhase 3

Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

United States238 participantsStarted 2021-03-09

Plain-language summary

This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305. For patients planned to receive idelalisib, known hypersensitivity, including anaphylaxis, to any component or excipient of idelalisib. For patients planned to receive bendamustine, known hypersensitivity, including anaphylaxis, to any component or excipient of bendamustine.
✕. Prior significant hypersensitivity to rituximab.

What they're measuring

Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)

Timeframe: Randomization to Disease Progression or Death Due to Any Cause (Up to 29 Months)

Trial details

NCT IDNCT04666038

SponsorLoxo Oncology, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-29

Results submitted2024-11-29

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