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A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) versus Ibrutinib in Patients with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

IQVIA Services Japan G.K. jRCT Inquiry Contac

IQVIA Services Japan G.K.

4-10-18 Takanawa, Minato-ku, Tokyo

+81-3-6859-9500

JP_LOXO-BTK-20030_CRA@iqvia.com

Recruiting

Nov. 04, 2022

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

-- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
-- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
-- Part 1 - Known 17p deletion status (wildtype or deleted). Part 2 - Must have deletion of 17p as determined by FISH testing
-- Adequate organ function
- Platelets greater than or equal to (>=)50 x 10^9/liter (L) or >=30 x 10^9/L in participants with documented bone marrow involvement considered to impair hematopoiesis,
- Hemoglobin >=8 grams/deciliter (g/dL) or >=6 g/dL in participants with documented bone marrow involvement considered to impair hematopoiesis
- Absolute neutrophil count >=0.75 x 10^9/L or >=0.50 x 10^9/L in participants with documented bone marrow involvement considered to impair hematopoiesis
- Kidney function: Estimated creatinine clearance >=30 milliliters per minute (mL/min)

- Known or suspected Richter's transformation to diffuse large B-cell lymphoma (DLBCL), prolymphocytic leukemia, or Hodgkin's lymphoma at any time preceding enrollment
- Known or suspected central nervous system (CNS) involvement
- A significant history of renal, neurologic, psychiatric, endocrine, metabolic or immunologic disease
- Active uncontrolled auto-immune cytopenia (e.g., autoimmune hemolytic anemia [AIHA], idiopathic thrombocytopenic purpura [ITP])
- Significant cardiovascular disease including ejection fraction < 40% and any grade ongoing atrial fibrillation or atrial flutter
- Hepatitis B or hepatitis C testing indicating active/ongoing infection, based on Screening laboratory tests
- Active cytomegalovirus (CMV) infection
- Active uncontrolled systemic bacterial, viral, or fungal infection
- Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
- Clinically significant active malabsorption syndrome or other condition likely to affect GI absorption of the oral-administered study treatments
- Ongoing inflammatory bowel disease
- Previous treatment for CLL/SLL - Part 1: Treatment-naive and previously treated, except prior exposure to BTK inhibitor (covalent or noncovalent).
Part 2: participants must be treatment naive
- Concurrent use of investigational agent or anticancer therapy except hormonal therapy
- Participants requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
- Use of >= 20 mg prednisone daily or equivalent dose of steroid at the time of first dose of study drug
- Vaccination with a live vaccine within 28 days prior to randomization
- Participants receiving chronic therapy with a strong cytochrome P450 (CYP)3A inhibitor (except posaconazole and voriconazole) which cannot be stopped within 3-5 half lives of the CYP3A inhibitor therapy prior to start of study drug treatment
- Participants with known hypersensitivity, including anaphylaxis, to any component or excipient of pirtobrutinib or ibrutinib

Both

Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

Drug: Pirtobrutinib
Administered orally.
Other Names:
LOXO-305
LY3527727
Drug: Ibrutinib
Administered orally.

[Study Arms]
Experimental: Pirtobrutinib Part1
Administered orally.
Intervention: Drug: Pirtobrutinib
Active Comparator: Ibrutinib
Administered orally.
Intervention: Drug: Ibrutinib

- Experimental: Pirtobrutinib Part2
Administered orally.
Intervention: Drug: Pirtobrutinib

Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 1 [ Time Frame: Baseline to best overall response at or before the initiation of subsequent anti-cancer therapy (if any) (approximately 3 years and 5 months) ]
ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria

- Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 2 [Time Frame: Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest (Approximately 2 years and 3 months)]
ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria

+81-23-628-5840

Oct. 04, 2022

Yes

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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