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JOURNAL ONKOLOGIE – STUDIE
BRUIN-CLL-314

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

Rekrutierend

NCT-Nummer:
NCT05254743

Studienbeginn:
Juli 2022

Letztes Update:
25.01.2024

Wirkstoff:
Pirtobrutinib, Ibrutinib

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

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Loxo Oncology, Inc.

Collaborator:
Eli Lilly and Company

Studienleiter

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company

Kontakt

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Kontakt:
Phone: 1-317-615-4559
E-Mail: ClinicalTrials.gov@lilly.com» Kontaktdaten anzeigen

Studienlocations
(3 von 204)

Stanford School of Medicine-Cancer Clinical Trials Office
94304 Palo Alto
United StatesRekrutierend» Google-Maps
Sharp Memorial Hospital
92123 San Diego
United StatesRekrutierend» Google-Maps
Northwest Georgia Oncology Centers
30060 Marietta
United StatesRekrutierend» Google-Maps
Westchester Medical Center
10532 Hawthorne
United StatesRekrutierend» Google-Maps
UTHSC Clinical Trails Unit
38104 Memphis
United StatesRekrutierend» Google-Maps
Fundação Pio XII - Hospital de Câncer de Barretos
14784-400 Barretos
BrazilRekrutierend» Google-Maps
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) - HCFMRP
14051-140 Ribeirão Preto
BrazilRekrutierend» Google-Maps
Ansprechpartner:

Phone: 16 98112-6986» Ansprechpartner anzeigen
Tel Aviv Sourasky Medical Center
6423906 Tel Aviv
IsraelRekrutierend» Google-Maps
University of Otago School of Medicine
9001 Dunedin
New ZealandRekrutierend» Google-Maps
Bristol Haematology and Oncology Centre
BS2 8ED Bristol
United KingdomRekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The purpose of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305)

to ibrutinib in participants with CLL/SLL. Participants may or may not have already had

treatment for their cancer. Participation could last up to six years.

Ein-/Ausschlusskriterien

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 (≥)50 x 10⁹/liter (L) or ≥30 x 10⁹/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 10⁹/L or ≥0.50 × 10⁹/L in participants with

documented bone marrow involvement considered to impair hematopoiesis

- Kidney function: Estimated creatinine clearance ≥30 milliliters per minute

(mL/min)

Exclusion Criteria:

- 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

- Prior exposure to BTK inhibitor (covalent or noncovalent)

- 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

Studien-Rationale

Primary outcome:

1. 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) (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



Secondary outcome:

1. Event-Free Survival (EFS) (Time Frame - Randomization to first occurrence of treatment discontinuation due to adverse event/toxicity, treatment-emergent atrial fibrillation or atrial flutter of any grade, progressive disease (PD) or death (approximately 4 years)):
EFS by IRC per iwCLL 2018 criteria

2. Progression-Free Survival (PFS) (Time Frame - Randomization to PD (per iwCLL 2018 criteria) or death from any cause (approximately 5 years 8 months)):
PFS by IRC per iwCLL 2018 criteria

3. Duration of Response (DOR) (Time Frame - Time from the date of the first documented response of CR, CRi, nPR or PR to the earlier of documentation of definitive PD (per iwCLL 2018 criteria) or death from any cause (approximately 2 years)):
DOR

4. Overall Survival (OS) (Time Frame - Randomization to death from any cause (approximately 6 years)):
OS

5. Time to Next Treatment (TTNT) (Time Frame - Randomization to initiation of the next systemic anticancer therapy for CLL/SLL or death from any cause, whichever occurs first (approximately 6 years)):
TTNT

6. Time to Worsening (TTW) of CLL/SLL Related Symptoms (Time Frame - Randomization to time to worsening symptoms (approximately 6 years)):
Using symptom questions identified from the EORTC item library. The range of raw scores for these items could be from 0 to 52 with highest score being worse symptoms.

Studien-Arme

  • Experimental: Pirtobrutinib
    Administered orally.
  • Active Comparator: Ibrutinib
    Administered orally.

Geprüfte Regime

  • Pirtobrutinib (LOXO-305 / LY3527727 / ):
    Administered orally.
  • Ibrutinib:
    Administered orally.

Quelle: ClinicalTrials.gov


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