A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322) (BRUIN CLL-322)

  • End date
    Jan 22, 2027
  • participants needed
  • sponsor
    Loxo Oncology, Inc.
Updated on 22 October 2022
chronic lymphocytic leukemia
neutrophil count


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.

Condition Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Treatment Rituximab, venetoclax, Pirtobrutinib
Clinical Study IdentifierNCT04965493
SponsorLoxo Oncology, Inc.
Last Modified on22 October 2022


Yes No Not Sure

Inclusion Criteria

Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L
Adequate organ function
Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
Estimated creatinine clearance ≥30 milliliters per minute (mL/min)

Exclusion Criteria

Known or suspected Richter's transformation at any time preceding enrollment
Prior therapy with a non-covalent (reversible) BTK inhibitor
Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers
Prior therapy with venetoclax
Central nervous system (CNS) involvement
Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
Active hepatitis B or hepatitis C
Known active cytomegalovirus (CMV) infection
Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
Significant cardiovascular disease
Vaccination with a live vaccine within 28 days prior to randomization
Patients with the following hypersensitivity
Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax
Prior significant hypersensitivity to rituximab
Known allergy to allopurinol and inability to take uric acid lowering agent
Clear my responses

How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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