Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.