Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
ACRUE
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)
1 other identifier
interventional
80
5 countries
57
Brief Summary
The study will measure the safety, tolerability, and efficacy with acalabrutinib in combination with rituximab in treatment-naïve elderly and/or frail patients with diffuse large B-cell lymphoma (DLBCL), who are otherwise unsuitable for standard front line chemoimmunotherapy treatments.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2024
Longer than P75 for phase_2
57 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2023
CompletedFirst Posted
Study publicly available on registry
July 19, 2023
CompletedStudy Start
First participant enrolled
July 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 25, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 25, 2029
May 5, 2026
May 1, 2026
4.7 years
July 11, 2023
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs)
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 Outcomes (7)
Objective response rate (ORR)
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)
Progression free survival (PFS)
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)
Event-Free Survival (EFS)
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)
Overall survival (OS)
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)
Duration of response (DoR)
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)
- +2 more secondary outcomes
Study Arms (1)
Acalabrutinib and Rituximab
EXPERIMENTALPatients 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.
Interventions
Patients will receive acalabrutinib orally with dosing schedule of X.
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.
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- 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.
- Serological positivity or known infection with 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 \> 17.
- History of or ongoing confirmed Progressive Multifocal Leukoencephalopathy.
- Known 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (57)
Research Site
Berkeley, California, 94704, United States
Research Site
La Jolla, California, 92093, United States
Research Site
Orange, California, 92868, United States
Research Site
Stamford, Connecticut, 06902, United States
Research Site
Jacksonville, Florida, 32256, United States
Research Site
Des Moines, Iowa, 50309, United States
Research Site
Lexington, Kentucky, 40536, United States
Research Site
Beltsville, Maryland, 20705, United States
Research Site
Towson, Maryland, 21204, United States
Research Site
Detroit, Michigan, 48202, United States
Research Site
Sioux Falls, South Dakota, 57104, United States
Research Site
Lubbock, Texas, 79410, United States
Research Site
Olympia, Washington, 98506, United States
Research Site
Tacoma, Washington, 98405, United States
Research Site
Barretos, 14784-400, Brazil
Research Site
Belo Horizonte, 30150-221, Brazil
Research Site
Brasília, 70200-730, Brazil
Research Site
Brasília, 70390-700, Brazil
Research Site
Brasília, 70840-901, Brazil
Research Site
Campinas, 13060-803, Brazil
Research Site
Curitiba, 81520-060, Brazil
Research Site
Florianópolis, 88020-210, Brazil
Research Site
Florianópolis, 88034-000, Brazil
Research Site
Goiânia, 74605-020, Brazil
Research Site
Natal, 59075-740, Brazil
Research Site
Porto Alegre, 90035-003, Brazil
Research Site
Porto Alegre, 90880-480, Brazil
Research Site
Recife, 50070-480, Brazil
Research Site
Ribeirão Preto, 14048-900, Brazil
Research Site
Rio de Janeiro, 20231-050, Brazil
Research Site
São José do Rio Preto, 15090-000, Brazil
Research Site
São Luís, 65060-645, Brazil
Research Site
São Paulo, 01229-010, Brazil
Research Site
São Paulo, 01409-02, Brazil
Research Site
São Paulo, 05652-900, Brazil
Research Site
São Paulo, 08270-070, Brazil
Research Site
São Paulo, 1323000, Brazil
Research Site
Sorocaba, 18030-005, Brazil
Research Site
San Juan, 00917, Puerto Rico
Research Site
Busan, 47392, South Korea
Research Site
Busan, 49241, South Korea
Research Site
Daegu, 42601, South Korea
Research Site
Gyeongsangnam-do, 52727, South Korea
Research Site
Incheon, 405-760, South Korea
Research Site
Jeonju, 54907, South Korea
Research Site
Seogu, 49201, South Korea
Research Site
Seoul, 03722, South Korea
Research Site
Seoul, 05505, South Korea
Research Site
Seoul, 06351, South Korea
Research Site
Seoul, 06591, South Korea
Research Site
Seoul, 07985, South Korea
Research Site
Suwon, 16499, South Korea
Research Site
Ulsan, 44033, South Korea
Research Site
Kaohsiung City, 80756, Taiwan
Research Site
Kaohsiung City, 833, Taiwan
Research Site
Tainan, 736, Taiwan
Research Site
Taipei, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2023
First Posted
July 19, 2023
Study Start
July 16, 2024
Primary Completion (Estimated)
March 25, 2029
Study Completion (Estimated)
March 25, 2029
Last Updated
May 5, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- 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.
- Access Criteria
- 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.
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.