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JOURNAL ONKOLOGIE – STUDIE
BRUIN CLL-322

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Rekrutierend

NCT-Nummer:
NCT04965493

Studienbeginn:
September 2021

Letztes Update:
26.01.2024

Wirkstoff:
Pirtobrutinib, Venetoclax, Rituximab

Indikation (Clinical Trials):
Lymphoma, Leukemia, Leukemia, Lymphoid, Leukemia, Lymphocytic, Chronic, B-Cell

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Loxo Oncology, Inc.

Collaborator:
Eli Lilly and Company

Studienleiter

James Pauff, MD
Study Director
Loxo Oncology

Kontakt

Studienlocations
(3 von 196)

Alle anzeigen

Studien-Informationen

Brief Summary:

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. To evaluate progression-free survival (PFS) of pirtobrutinib plus venetoclax and rituximab (Arm A) compared to venetoclax 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



Secondary outcome:

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

2. To evaluate the efficacy of Arm A compared to Arm B: Overall survival (OS) (Time Frame - Up to approximately 5 years):
Assessments of efficacy include OS

3. To evaluate the efficacy of Arm A compared to Arm B: Time to next treatment (TTNT) (Time Frame - Up to approximately 5 years):
Assessments of efficacy include TTNT

4. To evaluate the efficacy of Arm A compared to Arm B: Event-free survival (EFS) (Time Frame - Up to approximately 5 years):
Assessments of efficacy include EFS

5. To evaluate the efficacy of Arm A compared to Arm B: Overall response rate (ORR) (Time Frame - Up to approximately 5 years):
Assessments of efficacy include ORR

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

Studien-Arme

  • Experimental: Arm A (PVR)
    Fixed duration pirtobrutinib in combination with venetoclax and rituximab
  • Active Comparator: Arm B (VR)
    Venetoclax with rituximab

Geprüfte Regime

  • Pirtobrutinib (LOXO-305 / LY3527727 / ):
    Oral
  • Venetoclax (Venclexta / Venclyxto / ):
    Oral
  • Rituximab (Rituxan / MabThera / Truxima / Riabni / Ruxience / ):
    Intravenous (IV)

Quelle: ClinicalTrials.gov


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