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A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05023980
Recruitment Status : Recruiting
First Posted : August 27, 2021
Last Update Posted : March 6, 2023
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company ( Loxo Oncology, Inc. )

Study Description
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Brief Summary:
The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Drug: Pirtobrutinib Drug: Bendamustine Drug: Rituximab Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible patients will be randomized 1:1 into Arm A and Arm B. Patients randomized to Arm B who have disease progression (PD) confirmed by independent review committee (IRC) may be eligible to crossover into Arm A.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Actual Study Start Date : September 23, 2021
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : July 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm A (Pirtobrutinib)
Pirtobrutinib administered orally
 Drug: Pirtobrutinib
Oral
Other Names:
  • LOXO-305
  • LY3527727
Active Comparator: Arm B (BR)
Bendamustine plus rituximab administered intravenously (IV)
 Drug: Bendamustine
IV
Other Names:
  • Treanda
  • Treakisym
  • Ribomustin
  • Levact

Drug: Rituximab
IV
Other Names:
  • Rituxan
  • MabThera
  • Truxima
  • Riabni
  • Ruxience


Outcome Measures
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Primary Outcome Measures :
  1. To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B) [ Time Frame: Up to approximately 5 years ]
    Assessed by blinded independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 Response Criteria


Secondary Outcome Measures :
  1. To evaluate the effectiveness of Arm A compared to Arm B: Progression-free survival (PFS) [ Time Frame: Up to approximately 5 years ]
    Assessments of effectiveness include PFS, assessed by investigator

  2. To evaluate the effectiveness of Arm A compared to Arm B: Overall survival (OS) [ Time Frame: Up to approximately 5 years ]
    Assessments of effectiveness include OS, assessed by investigator

  3. To evaluate the effectiveness of Arm A compared to Arm B: Time to next treatment (TTNT) [ Time Frame: Up to approximately 5 years ]
    Assessments of effectiveness include TTNT, assessed by investigator

  4. To evaluate the effectiveness of Arm A compared to Arm B: Overall response rate (ORR) [ Time Frame: Up to approximately 5 years ]
    Assessments of effectiveness include ORR, assessed by investigator and IRC

  5. To evaluate the effectiveness of Arm A compared to Arm B: Duration of Response (DOR) [ Time Frame: Up to approximately 5 years ]
    Assessments of effectiveness include DOR, assessed by investigator and IRC

  6. To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms [ Time Frame: Up to approximately 5 years ]
    Based on time to worsening of CLL/SLL-related symptoms

  7. To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning [ Time Frame: Up to approximately 5 years ]
    Based on time to worsening of physical functioning


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed diagnosis of CLL/SLL requiring therapy, per iwCLL 2018 criteria
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Adequate organ function
  • Platelets greater than or equal to (≥)75 x 10⁹/liter (L) (≥50 × 10⁹/L for patients with evidence of bone marrow infiltrate), hemoglobin ≥8 grams/deciliter (g/dL), and absolute neutrophil count ≥0.75 x 10⁹/L
  • Kidney function: Estimated creatinine clearance ≥40 milliliters per minute (mL/min)

Exclusion Criteria:

  • Known or suspected Richter's transformation at any time preceding enrollment
  • Prior systemic therapy for CLL/SLL
  • Presence of 17p deletion
  • Central nervous system (CNS) involvement
  • Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
  • Significant cardiovascular disease
  • Active hepatitis B or hepatitis C
  • Active cytomegalovirus (CMV) infection
  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
  • Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
  • Concurrent use of investigational agent or anticancer therapy except hormonal therapy
  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
  • Vaccination with a live vaccine within 28 days prior to randomization

  • Patients with the following hypersensitivity:

    • Known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or bendamustine
    • Prior significant hypersensitivity to rituximab
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05023980


Contacts
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Contact: Patient Advocacy 1-855-LOXO-305 clinicaltrials@loxooncology.com

Locations
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Sponsors and Collaborators
Loxo Oncology, Inc.
Eli Lilly and Company
Investigators
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Study Director: Alex Levy, MD Loxo Oncology
More Information
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Additional Information:

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Responsible Party: Loxo Oncology, Inc.
ClinicalTrials.gov Identifier: NCT05023980    
Other Study ID Numbers: LOXO-BTK-20023
J2N-OX-JZNP ( Other Identifier: Eli Lilly and Company )
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: March 6, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company ( Loxo Oncology, Inc. ):
BTKi
BTK Inhibitor
Hematologic Disease
Lymphoma, non-Hodgkin's
Lymphoma, B-cell
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes
 Rituximab
Bendamustine Hydrochloride
Pirtobrutinib
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors