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RecruitingLast updated: 29 April 2026

BRUIN: This study is recruiting people with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma (CLL/SLL) to assess how safe and effective different dose levels of a targeted cancer drug called Pirtobrutinib isA Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

BRUIN

Clinical summary

Summary

The main purpose of this study is to assess the efficacy and safety of three dose levels of Pirtobrutinib targeted therapy in people with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma who have received 1-3 lines prior lines of treatment that included a covalent BTK inhibitor. 

Eligible participants will be randomly assigned to receive one of three different doses of Pirtobrutinib, which is a BTK inhibitor that will be administered orally.

The study is expected to last approximately 3 years.

 

Conditions

This trial is treating people with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma

Eligibility

Inclusion

  • Have confirmed diagnosis of CLL/SLL as defined by these iwCLL 2018 criteria.
  • Have received prior CLL/SLL treatment
  • Have received at least 1, but not more than 3 lines of prior treatment for CLL/SLL
  • Have received a covalent BTK inhibitor
  • Have a requirement for therapy consistent with iwCLL 2018 criteria for initiation of therapy
  • Capable of swallowing oral study medication.
  • Have an Eastern Cooperative Oncology Group Performance Status (ECOG) score of 0 to 2.

Exclusion

  • Have received prior treatment with a BTK degrader and a noncovalent BTK inhibitor
  • Have a history of greater than or equal to (>=) Grade 3 bleeding due to treatment with a BTK inhibitor
  • Have known or suspected Richter's transformation
  • Have known or suspected history of central nervous system involvement by CLL/SLL
  • Previous or concurrent cancer distinct from CLL/SLL within 3 years before randomization. Exceptions may occur with documented sponsor approval. Examples include:

    • nonmelanoma skin cancer or lentigo maligna melanoma
    • cervical carcinoma in situ
    • localized prostate cancer undergoing active surveillance, and
    • localized (for example, lymph node negative) breast cancer with no evidence of active disease present for more than 3 years. Individual may be receiving adjuvant hormonal therapy

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Loxo Oncology, Inc.

Scientific Title

A Phase 2, Open-Label, Randomized Study Evaluating the Efficacy and Safety of 3 Doses of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Who Previously Received Treatment With a Covalent Bruton Tyrosine Kinase Inhibitor

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