Large B-cell LymphomaPhase 3SOUNDTRACK-D2NCT07215585
AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL
A Phase 3 study testing AZD0486 and R-mini-CHOP in people with Large B-cell Lymphoma, run by AstraZeneca at 82 sites in 12 countries.
Trial summary
The purpose of this study is to measure the efficacy and safety of R-mini-CHOP × 2 followed by AZD0486 compared with R-mini-CHOP × 6 in elderly or unfit participants newly diagnosed with LBCL. Read more about this study
- Who is it for?
- Ages 65 to 130 years
- Conditions the study is for
- Large B-cell Lymphoma
- What is being tested?
- AZD0486 and R-mini-CHOP
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 82 sitesin 12 countries
- Study dates
- 11 Nov 2025to 29 Jul 2033
- Phase
- Phase 3
- 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 130 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP per investigator assessment;
- Histologically confirmed diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma) and follicular large cell lymphoma;
- FDG-avid and measurable disease as per Lugano and Ann Arbor staging;
- Stage I bulky (7.5 cm and greater) to Stage IV;
- ECOG performance status 0 to 2;
- Adequate bone marrow, liver, renal and cardiac function.
Show all 16Show fewer
- The above is a summary, other inclusion criteria details may apply.
- As judged by the investigator, any evidence of diseases which make it undesirable for the participant to participate in the study, or that would jeopardise compliance with the protocol
- Diagnosis of post-transplant lymphoproliferative disease, plasmablastic lymphoma, Richter's transformation, prior history of or concurrent indolent lymphoma (including de novo transformed or composite lymphoma).
- History of CNS involvement by their B-NHL or history of clinically relevant CNS medical condition
- Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).
- Active or uncontrolled infection
- Major cardiac abnormalities
- Prior anti-lymphoma therapy except for corticosteroids for symptom control
- Requires chronic immunosuppressive therapy for active autoimmune/inflammatory condition, with some exceptions
- The above is a summary, other exclusion criteria details may apply.
Who cannot join
None listed.
Trial locations and contacts
82 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
82 sites in 12 countries
China21 sites, 20 recruiting
- Recruiting
Research Site
Beijing, 100730
- Recruiting
Research Site
Changchun, 130021
- Recruiting
Research Site
Chengdu, 610041
- Not yet recruiting
Research Site
Chongqing, 400042
- Not yet recruiting
Research Site
Fuzhou, 350011
- Recruiting
Research Site
Guangzhou, 510060
- Not yet recruiting
Research Site
Guangzhou, 510280
- Not yet recruiting
Research Site
Guiyang, 550044
- Not yet recruiting
Research Site
Haikou, 570311
- Not yet recruiting
Research Site
Harbin, 150081
- Not yet recruiting
Research Site
Hefei, 230012
- Recruiting
Research Site
Jinan, 250117
- Not yet recruiting
Research Site
Kunming, 650101
- Not yet recruiting
Research Site
Nanchang, 330000
- Not yet recruiting
Research Site
Nanning, 530021
- Withdrawn
Research Site
Nantong, 226001
- Recruiting
Research Site
Shanghai, 200003
- Recruiting
Research Site
Shanghai, 20032
- Not yet recruiting
Research Site
Shenyang, 110004
- Not yet recruiting
Research Site
Wuhan, 430030
- Not yet recruiting
Research Site
Xiamen, 361003
Japan18 sites, 17 recruiting
- Withdrawn
Research Site
Akashi, 673-8558
- Recruiting
Research Site
Bunkyō City, 113-8677
- Not yet recruiting
Research Site
Himeji-shi, 670-8540
- Recruiting
Research Site
Kōtoku, 135-8550
- Not yet recruiting
Research Site
Kumamoto, 860-8556
- Not yet recruiting
Research Site
Matsumoto-shi, 399-8701
- Not yet recruiting
Research Site
Matsuyama, 791-0280
- Recruiting
Research Site
Meguro-ku, 152-8902
- Not yet recruiting
Research Site
Nagoya, 460-0001
- Not yet recruiting
Research Site
Nagoya, 466-8650
- Not yet recruiting
Research Site
Okayama, 701-1192
- Not yet recruiting
Research Site
Osaka, 543-8555
- Recruiting
Research Site
Osaka, 545-8586
- Not yet recruiting
Research Site
Otaki-Shi, 739-0696
- Not yet recruiting
Research Site
Sapporo, 003-0804
- Not yet recruiting
Research Site
Sunto-gun, 411-8777
- Recruiting
Research Site
Yamagata, 990-9585
- Recruiting
Research Site
Yokohama, 241-8515
Canada7 sites, 6 recruiting
- Recruiting
Research Site
Calgary, Alberta, T2N 5G2
- Not yet recruiting
Research Site
Chicoutimi, Quebec, G7H 5H6
- Withdrawn
Research Site
Hamilton, Ontario, L8V 5C2
- Not yet recruiting
Research Site
Oshawa, Ontario, L1G 2B9
- Recruiting
Research Site
Ottawa, Ontario, K1H 8L6
- Not yet recruiting
Research Site
Toronto, Ontario, M5G 2M9
- Not yet recruiting
Research Site
Victoria, British Columbia, V8R 6V5
Belgium6 sites, 4 recruiting
- Withdrawn
Research Site
Antwerp, 2030
- Not yet recruiting
Research Site
Brussels, 1200
- Recruiting
Research Site
Ghent, 9000
- Recruiting
Research Site
Leuven, 3000
- Withdrawn
Research Site
Roeselare, 8800
- Recruiting
Research Site
Yvoir, 5530
Australia5 sites, 4 recruiting
- Not yet recruiting
Research Site
Clayton, 3168
- Withdrawn
Research Site
Macquarie University, 2109
- Recruiting
Research Site
Melbourne, 3000
- Not yet recruiting
Research Site
Nedlands, 6009
- Not yet recruiting
Research Site
Waratah, 2298
Poland5 sites, 5 recruiting
- Not yet recruiting
Research Site
Kielce, 25-734
- Recruiting
Research Site
Krakow, 30-727
- Not yet recruiting
Research Site
Lodz, 93-513
- Not yet recruiting
Research Site
Lublin, 20-090
- Not yet recruiting
Research Site
Wroclaw, 50-367
Turkey (Türkiye)5 sites, 5 recruiting
- Recruiting
Research Site
Ankara, 06620
- Recruiting
Research Site
Antalya, 07025
- Not yet recruiting
Research Site
Istanbul, 34214
- Not yet recruiting
Research Site
Izmir, 35040
- Not yet recruiting
Research Site
Kocaeli, 41380
United Kingdom5 sites, 3 recruiting
- Withdrawn
Research Site
Glasgow, Scotland, G12 0YN
- Recruiting
Research Site
London, NW1 2PG
- Not yet recruiting
Research Site
Manchester, M20 4BX
- Recruiting
Research Site
Newcastle upon Tyne, NE7 7AF
- Withdrawn
Research Site
Nottingham, NG5 1PB
Germany3 sites, 3 recruiting
- Not yet recruiting
Research Site
Berlin, 14165
- Not yet recruiting
Research Site
Dresden, 01307
- Not yet recruiting
Research Site
Rostock, 18057
Hong Kong3 sites, 2 recruiting
- Withdrawn
Research Site
Hong Kong, 999077
- Recruiting
Research Site
Hong Kong, 999077
- Not yet recruiting
Research Site
Lai Chi Kok
Brazil2 sites, 2 recruiting
- Recruiting
Research Site
Porto Alegre, 90035-003
- Recruiting
Research Site
São Paulo, 05652000
South Korea2 sites, 2 recruiting
- Recruiting
Research Site
Seoul, 03080
- Recruiting
Research Site
Seoul, 5505
About this study
Official title: A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 Followed by AZD0486 Versus R-mini-CHOP x6 in Elderly or Unfit Participants With Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)
The purpose of this study is to measure the efficacy and safety of R-mini-CHOP × 2 followed by AZD0486 compared with R-mini-CHOP × 6 in elderly or unfit participants newly diagnosed with LBCL.
- Conditions
- Large B-cell Lymphoma
- Being tested
- AZD0486, R-mini-CHOP
- Keywords
- Large B-cell Lymphoma, LBCL, AZD0486, CD3, CD19, TCE, B-cell malignancies, Soundtrack-D2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0486Drug
Also called TNB-486
Bispecific monoclonal IgG4 antibody
R-mini-CHOPDrug
Intravenous administration: Rituximab 375 mg/m2, Cyclophosphamide 400 mg/m2, Doxorubicin 25 mg/m2, Vincristine 1 mg, and Oral administration: Prednisone 40 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Phase III Arm A: R-mini-CHOP and AZD0486 | Experimental | 2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP3D. Receives: Drug: AZD0486; Drug: R-mini-CHOP |
| Phase III Arm B: R-mini-CHOP | Active comparator | 6 cycles of R-mini-CHOP per SoC regimen. Receives: Drug: R-mini-CHOP |
| Safety Run in: R-mini-CHOP and AZD0486 | Experimental | 2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP2D. Receives: Drug: AZD0486; Drug: R-mini-CHOP |
What is being measured
The primary outcome is the main question the study is designed to answer.
SRI - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
Incidence and severity of AEs, SAEs, AESIs, and events of clinical interest based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
Measured: Up to 1 year
SRI - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
AEs leading to study treatment discontinuation or dose modification based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
Measured: Up to 1 year
SRI - Determination of the recommended Phase III dose (RP3D)
The RP3D will be the dose of AZD0486 selected for the Phase 3 part based on safety data compiled during the Safety Run-In part
Measured: Up to 1 year
Phase 3 - To demonstrate the superiority of R-mini-CHOP x2 followed by AZD0486 compared to R-mini-CHOP x6 regimen.
Progression-free Surival (PFS), based on Lugano 2014 Response Criteria.
Measured: Up to 7 years
Secondary outcomes (16)
Safety Run-In and Phase 3 - ORR
ORR defined as the proportion of participants achieving either a PR or CR at timepoints defined in the study protocol, based on Lugano 2014 Response Criteria as determined by Investigator assessment.
Measured: Up to 7 years
Safety Run-In and Phase 3 - CR Rate
CR rate is defined as the proportion of participants achieving a CR at timepoints defined in the study protocol, based on Lugano 2014 Response Criteria as determined by Investigator assessment.
Measured: Up to 7 years
Safety Run-In and Phase 3 - DoR
DoR is defined as the time from the date of first documented response until the date of documented progression based on Lugano 2014 criteria as determined by Investigator assessment or death due to any cause.
Measured: Up to 7 years
Safety Run-In and Phase 3 - DoCR
DoCR is defined as the time from the date of first documented CR until the date of documented progression or death due to any cause, as assessed by the Investigator.
Measured: Up to 7 years
Safety Run-In and Phase 3 - PFS
PFS is defined as the time from date of the first dose to date of documented objective disease progression as per Lugano 2014 or death (by any cause in the absence of progression), as determined by Investigator assessment.
Measured: Up to 7 years
Safety Run In and Phase 3 - OS
OS defined as the time from date of the first dose until death due to any cause.
Measured: Up to 7 years
Phase 3 - Time from randomisation to second progression or death (PFS2)
PFS2 is defined as the time from randomisation to the earliest of the progression event (following the initial investigator-assessed progression), after first subsequent therapy, or death.
Measured: Up to 7 years
Phase 3 - Time to First Subsequent Therapy or Death (TFST)
TFST is defined as time from randomisation until the start date of first subsequent anti-lymphoma therapy after discontinuation of randomised treatment, or death due to any cause.
Measured: Up to 7 Years
Phase 3 - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
Incidence and severity of AEs, SAEs, AESIs, and events of clinical interest based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
Measured: Up to 7 years
Phase 3 - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
AEs leading to study treatment discontinuation or dose modification based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
Measured: Up to 7 years
Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: serum concentration of study drug
Maximum observed serum concentration of AZD0486.
Measured: Up to 7 years
Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: Maximum plasma concentration of the study drug (Cmax).
Maximum observed plasma concentration of AZD0486.
Measured: Up to 7 years
Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: Concentration of study drug reached before next dose (Ctrough).
Observed plasma concentration of AZD0486 right before next dose of AZD0486.
Measured: Up to 7 years
Safety Run-In and Phase 3 - To determine the immunogenicity of AZD0486
Summary of pre-existing and treatment induced ADAs for AZD0486 (positive or negative, titres) and the impact on PK, efficacy or safety.
Measured: Up to 7 years
Phase 3 - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486 versus R-mini-CHOP × 6
Evaluation of key participant-reported side effects (pain, fatigue) and overall treatment tolerability, lymphoma-specific concerns, and HRQoL.
Measured: Up to 7 years
Phase 3 - Efficacy evaluation of R-mini-CHOP × 2 followed by AZD0486 versus R-mini-CHOP × 6
Evaluation of key participant-reported side effects (pain, fatigue) and overall treatment tolerability, lymphoma-specific concerns, and HRQoL.
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2025
- Study start11 Nov 2025
- Primary completion10 Jun 2030 (estimated)
- Study completion29 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of 2 sequential parts: a safety run-in (SRI) followed by the phase III.
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Dickinson,, MBBS BS DMSc, Principal investigator, Peter MacCallum Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07215585
- Sponsor's protocol ID
- D7402C00001
- Other IDs
- 2025-522029-37-00, 2025
- Acronym
- SOUNDTRACK-D2
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2025
- Last updated
- 9 Oct 2026
- Results posted
- 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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicentre, Open-Label, Randomised Study Evaluating the Efficacy and Safety of R-mini-CHOP x2 Followed by AZD0486 Versus R-mini-CHOP x6 in Elderly or Unfit Participants With Newly Diagnosed Large B-cell Lymphoma (SOUNDTRACK-D2)
- ClinicalTrials.gov ID
- NCT07215585
- Acronym / sponsor ID
- SOUNDTRACK-D2 / D7402C00001
- Conditions
- Large B-cell Lymphoma
- Keywords
- Large B-cell Lymphoma, LBCL, AZD0486, CD3, CD19, TCE, B-cell malignancies, Soundtrack-D2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 10 Jun 2030 (estimated)
- Study completion
- 29 Jul 2033 (estimated)
- First posted
- 10 Oct 2025 (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 purpose of this study is to measure the efficacy and safety of R-mini-CHOP × 2 followed by AZD0486 compared with R-mini-CHOP × 6 in elderly or unfit participants newly diagnosed with LBCL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study consists of 2 sequential parts: a safety run-in (SRI) followed by the phase III.
| Arm | Type | Receives |
|---|---|---|
| Phase III Arm A: R-mini-CHOP and AZD0486 | Experimental | Drug: AZD0486, Drug: R-mini-CHOP2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP3D. |
| Phase III Arm B: R-mini-CHOP | Active comparator | Drug: R-mini-CHOP6 cycles of R-mini-CHOP per SoC regimen. |
| Safety Run in: R-mini-CHOP and AZD0486 | Experimental | Drug: AZD0486, Drug: R-mini-CHOP2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP2D. |
Who may qualify
- Ages
- 65 to 130 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (16 listed)
- Participants are either 80 years of age or older, OR 65 to 79 years of age or older and classified as unfit per sGA, and otherwise not considered candidates for full-dose R-CHOP per investigator assessment;
- Histologically confirmed diagnosis of previously untreated LBCL as per WHO-HEM5 (excluding plasmablastic lymphoma) and follicular large cell lymphoma;
- FDG-avid and measurable disease as per Lugano and Ann Arbor staging;
- Stage I bulky (7.5 cm and greater) to Stage IV;
- ECOG performance status 0 to 2;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| AZD0486Also: TNB-486Bispecific monoclonal IgG4 antibody | Drug | Phase III Arm A: R-mini-CHOP and AZD0486, Safety Run in: R-mini-CHOP and AZD0486 |
| R-mini-CHOPIntravenous administration: Rituximab 375 mg/m2, Cyclophosphamide 400 mg/m2, Doxorubicin 25 mg/m2, Vincristine 1 mg, and Oral administration: Prednisone 40 mg/m2 | Drug | Phase III Arm A: R-mini-CHOP and AZD0486, Phase III Arm B: R-mini-CHOP, Safety Run in: R-mini-CHOP and AZD0486 |
Primary outcome
SRI - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
Time frame: Up to 1 year
Incidence and severity of AEs, SAEs, AESIs, and events of clinical interest based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
SRI - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
Time frame: Up to 1 year
AEs leading to study treatment discontinuation or dose modification based on NCI CTCAE v5.0/ASTCT, vital signs, laboratory parameters.
SRI - Determination of the recommended Phase III dose (RP3D)
Time frame: Up to 1 year
The RP3D will be the dose of AZD0486 selected for the Phase 3 part based on safety data compiled during the Safety Run-In part
Phase 3 - To demonstrate the superiority of R-mini-CHOP x2 followed by AZD0486 compared to R-mini-CHOP x6 regimen.
Time frame: Up to 7 years
Progression-free Surival (PFS), based on Lugano 2014 Response Criteria.
16 secondary outcomes
Safety Run-In and Phase 3 - ORR
Time frame: Up to 7 years
Safety Run-In and Phase 3 - CR Rate
Time frame: Up to 7 years
Safety Run-In and Phase 3 - DoR
Time frame: Up to 7 years
Safety Run-In and Phase 3 - DoCR
Time frame: Up to 7 years
Safety Run-In and Phase 3 - PFS
Time frame: Up to 7 years
Safety Run In and Phase 3 - OS
Time frame: Up to 7 years
Phase 3 - Time from randomisation to second progression or death (PFS2)
Time frame: Up to 7 years
Phase 3 - Time to First Subsequent Therapy or Death (TFST)
Time frame: Up to 7 Years
Phase 3 - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
Time frame: Up to 7 years
Phase 3 - Tolerability evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events.
Time frame: Up to 7 years
Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: serum concentration of study drug
Time frame: Up to 7 years
Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: Maximum plasma concentration of the study drug (Cmax).
Time frame: Up to 7 years
Safety Run-In and Phase 3 - Pharmacokinetics of AZD0486: Concentration of study drug reached before next dose (Ctrough).
Time frame: Up to 7 years
Safety Run-In and Phase 3 - To determine the immunogenicity of AZD0486
Time frame: Up to 7 years
Phase 3 - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486 versus R-mini-CHOP × 6
Time frame: Up to 7 years
Phase 3 - Efficacy evaluation of R-mini-CHOP × 2 followed by AZD0486 versus R-mini-CHOP × 6
Time frame: Up to 7 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 9 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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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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
Michael Dickinson,, MBBS BS DMSc principal investigator
Peter MacCallum Cancer Center
82 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AZD0486 and R-mini-CHOP in people with Large B-cell Lymphoma, run by AstraZeneca at 82 sites in 12 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 16 inclusion and 0 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 9 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 82 sites in China, Japan, Canada, Belgium, Australia and 7 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
SRI - Safety evaluation of R-mini-CHOP × 2 followed by AZD0486: Number of participants with treatment-related adverse events. (time frame: Up to 1 year). The study lists 4 primary outcomes in all. 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 9 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.