Diffuse Large B-Cell LymphomaPhase 2ACRUENCT05952024
Study of Acalabrutinib and Rituximab in Untreated Elderly and/or Frail Patients With DLBCL
A Phase 2 study testing Acalabrutinib and Rituximab in people with Diffuse Large B-Cell Lymphoma, run by AstraZeneca at 57 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- Acalabrutinib and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 57 sitesin 5 countries
- Study dates
- 16 Jul 2024to 22 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
57 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
57 sites in 5 countries
Brazil24 sites, 23 recruiting
- Recruiting
Research Site
Barretos, 14784-400
- Recruiting
Research Site
Belo Horizonte, 30150-221
- Recruiting
Research Site
Brasília, 70200-730
- Recruiting
Research Site
Brasília, 70390-700
- Recruiting
Research Site
Brasília, 70840-901
- Recruiting
Research Site
Campinas, 13060-803
- Recruiting
Research Site
Curitiba, 81520-060
- Recruiting
Research Site
Florianópolis, 88020-210
- Recruiting
Research Site
Florianópolis, 88034-000
- Recruiting
Research Site
Goiânia, 74605-020
- Recruiting
Research Site
Natal, 59075-740
- Recruiting
Research Site
Porto Alegre, 90035-003
- Recruiting
Research Site
Porto Alegre, 90880-480
- Recruiting
Research Site
Recife, 50070-480
- Recruiting
Research Site
Ribeirão Preto, 14048-900
- Recruiting
Research Site
Rio de Janeiro, 20231-050
- Recruiting
Research Site
São José do Rio Preto, 15090-000
- Recruiting
Research Site
São Luís, 65060-645
- Recruiting
Research Site
São Paulo, 01229-010
- Recruiting
Research Site
São Paulo, 01409-02
- Recruiting
Research Site
São Paulo, 05652-900
- Completed
Research Site
São Paulo, 08270-070
- Recruiting
Research Site
São Paulo, 1323000
- Recruiting
Research Site
Sorocaba, 18030-005
United States14 sites, 8 recruiting
- Recruiting
Research Site
Beltsville, Maryland, 20705
- Withdrawn
Research Site
Berkeley, California, 94704
- Recruiting
Research Site
Des Moines, Iowa, 50309
- Recruiting
Research Site
Detroit, Michigan, 48202
- Recruiting
Research Site
Jacksonville, Florida, 32256
- Completed
Research Site
La Jolla, California, 92093
- Withdrawn
Research Site
Lexington, Kentucky, 40536
- Recruiting
Research Site
Lubbock, Texas, 79410
- Recruiting
Research Site
Olympia, Washington, 98506
- Withdrawn
Research Site
Orange, California, 92868
- Withdrawn
Research Site
Sioux Falls, South Dakota, 57104
- Withdrawn
Research Site
Stamford, Connecticut, 06902
- Recruiting
Research Site
Tacoma, Washington, 98405
- Recruiting
Research Site
Towson, Maryland, 21204
South Korea14 sites, 14 recruiting
- Recruiting
Research Site
Busan, 47392
- Recruiting
Research Site
Busan, 49241
- Recruiting
Research Site
Daegu, 42601
- Recruiting
Research Site
Gyeongsangnam-do, 52727
- Recruiting
Research Site
Incheon, 405-760
- Recruiting
Research Site
Jeonju, 54907
- Recruiting
Research Site
Seogu, 49201
- Recruiting
Research Site
Seoul, 03722
- Recruiting
Research Site
Seoul, 05505
- Recruiting
Research Site
Seoul, 06351
- Recruiting
Research Site
Seoul, 06591
- Recruiting
Research Site
Seoul, 07985
- Recruiting
Research Site
Suwon, 16499
- Recruiting
Research Site
Ulsan, 44033
Taiwan4 sites
- Withdrawn
Research Site
Kaohsiung City, 80756
- Withdrawn
Research Site
Kaohsiung City, 833
- Withdrawn
Research Site
Tainan, 736
- Withdrawn
Research Site
Taipei, 100
About this study
Official 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)
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.
Read the detailed description
Treatment-naïve elderly and/or frail patients with DLBCL will be treated with acalabrutinib in combination with rituximab in a single arm.
Study details include the following:
- The study duration will be up to 108 weeks for each patient, including up to 28 days for screening and 104 weeks of treatment and follow-up.
- The treatment duration will be up to 8 cycles for rituximab and 28 cycles for acalabrutinib both beginning at cycle 1.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- Acalabrutinib, Rituximab
- Keywords
- Chemoimmunotherapy treatments, Treatment-naïve elderly patients
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcalabrutinibDrug
Also called CALQUENCE®
Patients will receive acalabrutinib orally with dosing schedule of X.
RituximabBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Acalabrutinib and Rituximab | Experimental | 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. Receives: Drug: Acalabrutinib; Biological: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Change from baseline in Timed Up and Go test (TUG)
Measured: 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)
Number of patients with adverse events
Measured: Screening (up to 28 days before day 1) Until Post-treatment follow-up (Up to 3.5 Years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start16 Jul 2024
- Primary completion22 Apr 2029 (estimated)
- Study completion22 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952024
- Sponsor's protocol ID
- D8227C00002
- Acronym
- ACRUE
- Status last verified
- Oct 2026
- First submitted
- 11 Jul 2023
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT05952024
- Acronym / sponsor ID
- ACRUE / D8227C00002
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- Chemoimmunotherapy treatments, Treatment-naïve elderly patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 22 Apr 2029 (estimated)
- Study completion
- 22 Apr 2029 (estimated)
- First posted
- 19 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Treatment-naïve elderly and/or frail patients with DLBCL will be treated with acalabrutinib in combination with rituximab in a single arm.
Study details include the following:
- The study duration will be up to 108 weeks for each patient, including up to 28 days for screening and 104 weeks of treatment and follow-up.
- The treatment duration will be up to 8 cycles for rituximab and 28 cycles for acalabrutinib both beginning at cycle 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acalabrutinib and Rituximab | Experimental | Drug: Acalabrutinib, Biological: RituximabPatients 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. |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- ≥ 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 .
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcalabrutinibAlso: CALQUENCE®Patients will receive acalabrutinib orally with dosing schedule of X. | Drug | Acalabrutinib and Rituximab |
| RituximabPatients will receive rituximab via IV infusion on Cycle 1 Day 15 and via SC injection on Day 1 of Cycle 2 through Cycle 8. | Biological | Acalabrutinib and Rituximab |
Primary outcome
Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs)
Time frame: 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)
7 secondary outcomes
Objective response rate (ORR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Change from baseline in Timed Up and Go test (TUG)
Time frame: 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)
Number of patients with adverse events
Time frame: Screening (up to 28 days before day 1) Until Post-treatment follow-up (Up to 3.5 Years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Diffuse Large B-Cell Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
57 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acalabrutinib and Rituximab in people with Diffuse Large B-Cell Lymphoma, run by AstraZeneca at 57 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in Brazil, United States, South Korea, Taiwan, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with Grade 3 to 4 treatment emergent adverse events (TEAEs) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.