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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05023980




Registration number
NCT05023980
Ethics application status
Date submitted
24/08/2021
Date registered
27/08/2021
Date last updated
28/06/2024

Titles & IDs
Public title
A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Scientific 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
Secondary ID [1] 0 0
J2N-OX-JZNP
Secondary ID [2] 0 0
LOXO-BTK-20023
Universal Trial Number (UTN)
Trial acronym
BRUIN CLL-313
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Small Lymphocytic Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pirtobrutinib
Treatment: Drugs - Bendamustine
Treatment: Drugs - Rituximab

Experimental: Arm A (Pirtobrutinib) - Pirtobrutinib administered orally

Active comparator: Arm B (BR) - Bendamustine plus rituximab administered intravenously (IV)


Treatment: Drugs: Pirtobrutinib
Oral

Treatment: Drugs: Bendamustine
IV

Treatment: Drugs: Rituximab
IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate progression-free survival (PFS) of pirtobrutinib (Arm A) compared to bendamustine and rituximab (Arm B)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [1] 0 0
To evaluate the effectiveness of Arm A compared to Arm B: Progression-free survival (PFS)
Timepoint [1] 0 0
Up to approximately 5 years
Secondary outcome [2] 0 0
To evaluate the effectiveness of Arm A compared to Arm B: Overall survival (OS)
Timepoint [2] 0 0
Up to approximately 5 years
Secondary outcome [3] 0 0
To evaluate the effectiveness of Arm A compared to Arm B: Time to next treatment (TTNT)
Timepoint [3] 0 0
Up to approximately 5 years
Secondary outcome [4] 0 0
To evaluate the effectiveness of Arm A compared to Arm B: Overall response rate (ORR)
Timepoint [4] 0 0
Up to approximately 5 years
Secondary outcome [5] 0 0
To evaluate the effectiveness of Arm A compared to Arm B: Duration of Response (DOR)
Timepoint [5] 0 0
Up to approximately 5 years
Secondary outcome [6] 0 0
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported disease-related symptoms
Timepoint [6] 0 0
Up to approximately 5 years
Secondary outcome [7] 0 0
To evaluate the effectiveness of Arm A compared to Arm B in patient-reported physical functioning
Timepoint [7] 0 0
Up to approximately 5 years

Eligibility
Key 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 10?/liter (L) (=50 × 10?/L for patients with evidence of bone marrow infiltrate), hemoglobin =8 grams/deciliter (g/dL), and absolute neutrophil count =0.75 x 10?/L
* Kidney function: Estimated creatinine clearance =40 milliliters per minute (mL/min)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 0 0
Westmead Hospital - Wentworthville
Recruitment hospital [3] 0 0
Peninsula Private Hospital - Frankston
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2145 - Wentworthville
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
Austria
State/province [5] 0 0
Salzburg
Country [6] 0 0
Austria
State/province [6] 0 0
Vienna
Country [7] 0 0
Brazil
State/province [7] 0 0
Rio Grande Do Sul
Country [8] 0 0
Brazil
State/province [8] 0 0
São Paulo
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Plovdiv
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Sofia
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Stara Zagora
Country [12] 0 0
China
State/province [12] 0 0
Anhui
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Guangdong
Country [15] 0 0
China
State/province [15] 0 0
Hubei
Country [16] 0 0
China
State/province [16] 0 0
Hunan
Country [17] 0 0
China
State/province [17] 0 0
Inner Mongolia
Country [18] 0 0
China
State/province [18] 0 0
Jiangxi
Country [19] 0 0
China
State/province [19] 0 0
Liaoning
Country [20] 0 0
China
State/province [20] 0 0
Nanjing
Country [21] 0 0
China
State/province [21] 0 0
Shanghai
Country [22] 0 0
China
State/province [22] 0 0
Sichuan
Country [23] 0 0
China
State/province [23] 0 0
Tianjin
Country [24] 0 0
China
State/province [24] 0 0
Zhejiang
Country [25] 0 0
China
State/province [25] 0 0
Chongqing
Country [26] 0 0
China
State/province [26] 0 0
Zhengzhou
Country [27] 0 0
Czechia
State/province [27] 0 0
Brno
Country [28] 0 0
Czechia
State/province [28] 0 0
Hradec Kralove
Country [29] 0 0
France
State/province [29] 0 0
Le Mans
Country [30] 0 0
Hungary
State/province [30] 0 0
Debrecen
Country [31] 0 0
Hungary
State/province [31] 0 0
Nyíregyháza
Country [32] 0 0
Hungary
State/province [32] 0 0
Székesfehérvár
Country [33] 0 0
Italy
State/province [33] 0 0
Potenza
Country [34] 0 0
Italy
State/province [34] 0 0
Bergamo
Country [35] 0 0
Italy
State/province [35] 0 0
Brescia
Country [36] 0 0
Italy
State/province [36] 0 0
Meldola
Country [37] 0 0
Italy
State/province [37] 0 0
Milano
Country [38] 0 0
Italy
State/province [38] 0 0
Monza
Country [39] 0 0
Italy
State/province [39] 0 0
Novara
Country [40] 0 0
Italy
State/province [40] 0 0
Perugia
Country [41] 0 0
Italy
State/province [41] 0 0
Ravenna
Country [42] 0 0
Italy
State/province [42] 0 0
Terni
Country [43] 0 0
Italy
State/province [43] 0 0
Trieste
Country [44] 0 0
Japan
State/province [44] 0 0
Aichi
Country [45] 0 0
Japan
State/province [45] 0 0
Chiba
Country [46] 0 0
Japan
State/province [46] 0 0
Fukui
Country [47] 0 0
Japan
State/province [47] 0 0
Hokkaido
Country [48] 0 0
Japan
State/province [48] 0 0
Kochi
Country [49] 0 0
Japan
State/province [49] 0 0
Miyagi-Ken
Country [50] 0 0
Japan
State/province [50] 0 0
Miyagi
Country [51] 0 0
Japan
State/province [51] 0 0
Saitama
Country [52] 0 0
Japan
State/province [52] 0 0
Yamanshi
Country [53] 0 0
Japan
State/province [53] 0 0
Aomori
Country [54] 0 0
Japan
State/province [54] 0 0
Fukoka-ken
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Incheon-gwangyeoksi [Incheon]
Country [56] 0 0
Korea, Republic of
State/province [56] 0 0
Seoul, Korea
Country [57] 0 0
Korea, Republic of
State/province [57] 0 0
Seoul-teukbyeolsi [Seoul]
Country [58] 0 0
Korea, Republic of
State/province [58] 0 0
Seoul
Country [59] 0 0
Korea, Republic of
State/province [59] 0 0
Busan
Country [60] 0 0
New Zealand
State/province [60] 0 0
Auckland
Country [61] 0 0
New Zealand
State/province [61] 0 0
Bay Of Plenty
Country [62] 0 0
New Zealand
State/province [62] 0 0
Christchurch
Country [63] 0 0
New Zealand
State/province [63] 0 0
Papatoetoe
Country [64] 0 0
Poland
State/province [64] 0 0
Legnica
Country [65] 0 0
Poland
State/province [65] 0 0
Lubelskie V
Country [66] 0 0
Poland
State/province [66] 0 0
Pomorskie
Country [67] 0 0
Poland
State/province [67] 0 0
Poznan
Country [68] 0 0
Poland
State/province [68] 0 0
Biala Podlaska
Country [69] 0 0
Poland
State/province [69] 0 0
Bydgoszcz
Country [70] 0 0
Poland
State/province [70] 0 0
Katowice
Country [71] 0 0
Poland
State/province [71] 0 0
Kraków
Country [72] 0 0
Poland
State/province [72] 0 0
Lublin
Country [73] 0 0
Poland
State/province [73] 0 0
Torun
Country [74] 0 0
Poland
State/province [74] 0 0
Warsaw
Country [75] 0 0
Poland
State/province [75] 0 0
Wroclaw
Country [76] 0 0
Portugal
State/province [76] 0 0
Braga
Country [77] 0 0
Portugal
State/province [77] 0 0
Lisboa
Country [78] 0 0
Portugal
State/province [78] 0 0
Porto
Country [79] 0 0
Romania
State/province [79] 0 0
Dolj
Country [80] 0 0
Romania
State/province [80] 0 0
Bucuresti
Country [81] 0 0
Romania
State/province [81] 0 0
Cluj-Napoca
Country [82] 0 0
Romania
State/province [82] 0 0
Iasi
Country [83] 0 0
Russian Federation
State/province [83] 0 0
St-Petersburg
Country [84] 0 0
Spain
State/province [84] 0 0
Asturias
Country [85] 0 0
Spain
State/province [85] 0 0
Madrid, Comunidad De
Country [86] 0 0
Spain
State/province [86] 0 0
Barcelona
Country [87] 0 0
Spain
State/province [87] 0 0
Madrid
Country [88] 0 0
Spain
State/province [88] 0 0
Sevilla
Country [89] 0 0
Taiwan
State/province [89] 0 0
Changhua
Country [90] 0 0
Taiwan
State/province [90] 0 0
Taichung
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taipei
Country [92] 0 0
Taiwan
State/province [92] 0 0
Taoyuan City
Country [93] 0 0
United Kingdom
State/province [93] 0 0
England

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Loxo Oncology, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Eli Lilly and Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05023980
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Alex Levy, MD
Address 0 0
Loxo Oncology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05023980