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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05952024




Registration number
NCT05952024
Ethics application status
Date submitted
11/07/2023
Date registered
19/07/2023

Titles & IDs
Public title
Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
Scientific title
A Prospective, Open-Label, Single-Arm, Phase II Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With Diffuse Large B-Cell Lymphoma (ACRUE)
Secondary ID [1] 0 0
D8227C00002
Universal Trial Number (UTN)
Trial acronym
ACRUE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell 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

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

Experimental: Acalabrutinib and Rituximab - Patients will receive Dose A of acalabrutinib orally in X dosing schedule beginning on Cycle 1 Day 1 for a maximum of 28 cycles or until 2014 Lugano Classification for Non-Hodgkin's Lymphoma (NHL)-defined disease progression or another discontinuation criterion is met. Patients will also receive an intravenous (IV) infusion of Dose B rituximab on Cycle 1 Day 15 and Dose C of rituximab as an subcutaneous (SC) injection on Day 1 of Cycle 2 through Cycle 8.


Treatment: Drugs: Acalabrutinib
Patients will receive acalabrutinib orally with dosing schedule of X.

Treatment: Other: Rituximab
Patients will receive rituximab via IV infusion on Cycle 1 Day 15 and via SC injection on Day 1 of Cycle 2 through Cycle 8.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs)
Timepoint [1] 0 0
Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) through End of treatment EoT [30 days of discontinuation] (Up to 3.5 Years)
Secondary outcome [1] 0 0
Objective response rate (ORR)
Timepoint [1] 0 0
Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years)
Secondary outcome [2] 0 0
Progression free survival (PFS)
Timepoint [2] 0 0
Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years)
Secondary outcome [3] 0 0
Event-Free Survival (EFS)
Timepoint [3] 0 0
Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years)
Secondary outcome [4] 0 0
Overall survival (OS)
Timepoint [4] 0 0
Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until Post-treatment follow-up (Up to 3.5 Years)
Secondary outcome [5] 0 0
Duration of response (DoR)
Timepoint [5] 0 0
Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until disease progression or last evaluable assessment in the absence of progression (Up to 3.5 Years)
Secondary outcome [6] 0 0
Change from baseline in Timed Up and Go test (TUG)
Timepoint [6] 0 0
Cycle 1 Day 1 (Cycles 1 to 8 is 21 days and Cycles 9 to 28 is 28 days) Until Post-treatment follow-up (Up to 3.5 Years)
Secondary outcome [7] 0 0
Number of patients with adverse events
Timepoint [7] 0 0
Screening (up to 28 days before day 1) Until Post-treatment follow-up (Up to 3.5 Years)

Eligibility
Key inclusion criteria
* = 80 years of age at the time of screening, or
* = 65 to 79 years of age at the time of screening and considered ineligible for chemoimmunotherapy
* Histologically documented DLBCL
* No prior treatment for DLBCL
* Stage II, III, or IV disease by the Ann Arbor Classification .
* Eastern Cooperative Oncology Group performance status of 0, 1, or 2 with no deterioration over the previous 2 weeks prior to baseline or day of the first dosing except when due to underlying lymphoma.
* At least 1 lesion that can be accurately measured at baseline as = 10 mm in the longest diameter with computed tomography or magnetic resonance imaging and is suitable for accurate repeated measurements.
* Adequate organ and marrow function independent of growth factor or transfusion support within 1 week of Screening.
Minimum age
65 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any evidence of diseases (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, renal transplant, and active bleeding diseases), that would make the study undesirable for the patient or that would impact compliance with the protocol.
* History of prior or current malignancy, that would affect compliance with the protocol or interpretation of the results.
* Serologic status reflecting active hepatitis B or C infection.
* Known to have tested positive for HIV.
* Active central nervous system involvement by lymphoma, leptomeningeal disease, or spinal cord compression.
* Any comorbidity or organ system impairment rated with a single Cumulative Illness Rating Scale-Geriatric score (CIRS-G) of 4 or a total CIRS-G score of > 6.
* History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy.
* Known history of infection with HIV or any active significant infection.
* History of stroke or intracranial haemorrhage within 6 months before the first dose of study drug.
* History of bleeding diathesis (eg, haemophilia, von Willebrand disease).
* Any concurrent anticancer treatment.
* Major surgical procedure within 30 days of first dose of study intervention or anticipated major surgery during the study timeframe.
* Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists.
* Received a live virus vaccination within 28 days of the first dose of study drug.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
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
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/08/2027
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
South Dakota
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Brazil
State/province [11] 0 0
Barretos
Country [12] 0 0
Brazil
State/province [12] 0 0
Belo Horizonte
Country [13] 0 0
Brazil
State/province [13] 0 0
Brasilia
Country [14] 0 0
Brazil
State/province [14] 0 0
Campinas
Country [15] 0 0
Brazil
State/province [15] 0 0
Curitiba
Country [16] 0 0
Brazil
State/province [16] 0 0
Florianópolis
Country [17] 0 0
Brazil
State/province [17] 0 0
Goiania
Country [18] 0 0
Brazil
State/province [18] 0 0
Natal
Country [19] 0 0
Brazil
State/province [19] 0 0
Porto Alegre
Country [20] 0 0
Brazil
State/province [20] 0 0
Recife
Country [21] 0 0
Brazil
State/province [21] 0 0
Ribeirão Preto
Country [22] 0 0
Brazil
State/province [22] 0 0
Rio de Janeiro
Country [23] 0 0
Brazil
State/province [23] 0 0
Sao Luis
Country [24] 0 0
Brazil
State/province [24] 0 0
Sao Paulo
Country [25] 0 0
Brazil
State/province [25] 0 0
Sorocaba
Country [26] 0 0
Brazil
State/province [26] 0 0
São José do Rio Preto
Country [27] 0 0
Brazil
State/province [27] 0 0
São Paulo
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Busan
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Daegu
Country [30] 0 0
Korea, Republic of
State/province [30] 0 0
Gyeongsangnam-do
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Incheon
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Jeonju-si
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seo-gu
Country [34] 0 0
Korea, Republic of
State/province [34] 0 0
Seoul
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Suwon-si
Country [36] 0 0
Korea, Republic of
State/province [36] 0 0
Ulsan
Country [37] 0 0
Puerto Rico
State/province [37] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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.


Results not provided in https://clinicaltrials.gov/study/NCT05952024