Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
420
Countries
2
Sites
11
Large B-cell Lymphoma
Safety Run in:- To assess the safety and tolerability of R-mini-CHOP × 2 followed by AZD0486 in elderly/unfit participants - To confirm the dose and schedule of AZD0486 used in the Phase III part Phase 3: - To demonstrate the superiority of R-mini-CHOP × 2 followed by AZD0486 compared to R-mini-CHOP × 6 regimen by as…
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Feb 2026 → ongoing
- Decision date (initial)
- 2026-01-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacodynamic, Efficacy, Pharmacokinetic, Safety
Safety Run in:- To assess the safety and tolerability of R-mini-CHOP × 2 followed by AZD0486 in elderly/unfit participants
- To confirm the dose and schedule of AZD0486 used in the Phase III part
Phase 3:
- To demonstrate the superiority of R-mini-CHOP × 2 followed by AZD0486 compared to R-mini-CHOP × 6 regimen by assessment of PFS.
Secondary objectives 9
- Safety Run in: - To evaluate the efficacy of R-mini-CHOP × 2 followed by AZD0486 by efficacy measures
- Safety Run in: - To characterise pharmacokinetics of AZD0486 following R-mini-CHOP
- Safety Run in: - To describe the incidence of immunogenicity of AZD0486 following R-mini-CHOP
- Phase 3: - To demonstrate the superiority of R-mini-CHOP × 2 followed by AZD0486 compared to R-mini-CHOP × 6 regimen by assessment of OS
- Phase 3: - To demonstrate the superiority of R-mini-CHOP × 2 followed by AZD0486 compared to R-mini-CHOP × 6 regimen by evaluation of additional efficacy measures
- Phase 3: - To assess the safety and tolerability of R-mini-CHOP × 2 followed by AZD0486
- Phase 3:- To characterise PK of R-mini-CHOP × 2 followed by AZD0486
- Phase 3:- To describe the incidence of immunogenicity of R-mini-CHOP × 2 followed by AZD0486
- Phase 3:- To evaluate the efficacy and safety of R-mini-CHOP × 2 followed by AZD0486 versus R-mini-CHOP × 6 by evaluation of key participant-reported side effects (pain, fatigue) and overall treatment tolerability, lymphoma-specific concerns, and HRQoL
Conditions and MedDRA coding
Large B-cell Lymphoma
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Safety Run in and Phase III Safety Run in and Phase III
|
Randomised Controlled | Single | [{"id":177520,"code":3,"name":"Monitor"}] | Safety Run in: R-mini-CHOP followed sequentially by AZD0486 at RP2D Phase III Arm A: 2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 Phase III Arm B: 6 cycles of R-mini-CHOP per SoC regimen |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- 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 shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- 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.
- The above is a summary, other inclusion criteria details may apply.
Exclusion criteria 9
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 4
- Safety Run in: Incidence and severity of AEs, SAEs, AESIs, and events of clinical interest;
- Safety Run in: AEs/AEs leading to discontinuation or dose modification of AZD0486
- Safety Run in: Clinically significant alterations in vital signs and abnormal laboratory parameters
- Phase 3: PFS defined as the time from date of randomisation until disease progression as per Lugano 2014 as assessed by BICR, or death due to any cause
Secondary endpoints 12
- Safety Run in: ORR, CR Rate, DoR, DoCR, PFS, OS
- Safety Run in: Concentration of AZD0486 in serum and PK parameters as data permits following R-mini-CHOP
- Safety Run in: Summary of pre-existing and treatment induced ADAs for AZD0486 and the impact on PK, efficacy or safety
- Phase 3: OS
- Phase 3: ORR, CR rate, DoR, DoCR, PFS, PFS2, TFST
- Phase 3: AEs, SAEs, AESIs, events of clinical interest, AEs leading to study treatment discontinuation or dose modification
- Phase 3: Concentration of AZD0486 in serum and PK parameters as data permits following R-mini-CHOP
- Phase 3: Summary of pre-existing and treatment induced ADAs for AZD0486 (positive or negative, titres) and the impact on PK, efficacy or safety
- Phase 3: eCOA: - Proportion reporting different levels of pain and tirednesswhile on treatment using items from the FACT-LymS subsetfor all dosed participants
- Phase 3: eCOA: - Proportion reporting each level of overall side effect bother on the PGI-TT, while on treatment for all dosed participants
- Phase 3: eCOA: - Change from baseline on lymphoma-specific concerns based on FACT-LymS scores for all randomised participants
- Phase 3: eCOA: - Change from baseline on overall HRQoL (based on QL2 item scores) for all randomised participants
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
Ruxience 500 mg concentrate for solution for infusion
PRD7980794 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 10 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/20/1431/002
- MA holder
- PFIZER EUROPE MA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelling performed, no change to primary orsecondary packaging
MabThera 500 mg concentrate for solution for infusion
PRD2154043 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 10 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/98/067/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelling performed, no change to primary orsecondary packaging
PRD12392694 · Product
- Active substance
- Surovatamig
- Substance synonyms
- Human IgG4 kappa monoclonal antibody against CD3 and CD19, TNB-486, AZD0486
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
PRD10472872 · Product
- Active substance
- Human IGG4 Kappa Monoclonal Antibody Against CD3 and CD19
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 36 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ASTRAZENECA AB
- Paediatric formulation
- No
- Orphan designation
- No
Truxima 500 mg concentrate for solution for infusion
PRD4797328 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 10 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/16/1167/001
- MA holder
- CELLTRION HEALTHCARE HUNGARY KFT
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Over-labelling performed, no change to primary or secondary packaging
Comparator 4
PRD784741 · Product
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- H02AB07 — PREDNISONE
- Marketing authorisation
- 33641.00.00
- MA holder
- GALENPHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ribodoxo® 2 mg/ml Injektionslösung
PRD10845883 · Product
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- 24959.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vincristine Sulfate 1 mg/ml solution for injection
PRD11830443 · Product
- Active substance
- Vincristine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 0 mg/ml milligram(s)/millilitre
- Max total dose
- 0 mg/ml milligram(s)/millilitre
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CA02 — VINCRISTINE
- Marketing authorisation
- PL 04515/0008
- MA holder
- HOSPIRA UK LIMITED,WALTON OAKS
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Endoxan 500 mg, poeder voor oplossing voor injectie
PRD350463 · Product
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- BE 000682
- MA holder
- BAXTER SA
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 3
Neulasta 6 mg solution for injection
PRD373150 · Product
- Active substance
- Pegfilgrastim
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 99 Week(s)
- Authorisation status
- Authorised
- ATC code
- L03AA13 — PEGFILGRASTIM
- Marketing authorisation
- EU/1/02/227/002
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RoActemra 20 mg/mL concentrate for solution for infusion
PRD2154622 · Product
- Active substance
- Tocilizumab
- Substance synonyms
- RO4877533, BIIB800, ATLIZUMAB, TOCILIZUMABUM
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 00 mg/ml milligram(s)/millilitre
- Max total dose
- 00 mg/ml milligram(s)/millilitre
- Max treatment duration
- 99 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — -
- Marketing authorisation
- EU/1/08/492/003
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
RoActemra 20 mg/mL concentrate for solution for infusion
PRD2154624 · Product
- Active substance
- Tocilizumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 99 mg/ml milligram(s)/millilitre
- Max total dose
- 99 mg/ml milligram(s)/millilitre
- Max treatment duration
- 99 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC07 — -
- Marketing authorisation
- EU/1/08/492/005
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical trial information desk
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical trial information desk
Locations
2 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 14 | 6 |
| Poland | Ongoing, recruiting | 16 | 5 |
| Rest of world
Australia, Canada, Korea, Republic of, Switzerland, Hong Kong, Japan, China, Brazil, India, Turkey, United States, United Kingdom
|
— | 390 | — |
Investigational sites
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Hematology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Cliniques Universitaires Saint-Luc
Hematology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Algemeen Ziekenhuis Delta
Hematology, Deltalaan 1, 8800, Roeselare
Ziekenhuis Aan De Stroom
Hematology, Kempenstraat 100, 2030, Antwerp
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komorkowych i Chorob Wewnetrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddzial Hematolog¡i i Transplantacji Szpiku, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Hematoonkologii i Chorób Wewnętrznych z Pododdziałem Chemioterapii Dziennej, Ul. Pabianicka 62, 93-513, Lodz
Pratia S.A.
NA, Ul. Pana Tadeusza 2, 30-727, Cracow
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach
Klinika Hematologii i Transplantacji Szpiku, Ul. Prezydenta Stefana Artwinskiego 3, 25-734, Kielce
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2026-02-27 | 2026-03-17 | |||
| Poland | 2026-03-10 | 2026-03-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 33 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2025-522029-37-00_redacted | 2 EU |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adult PL_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF Adult Safety Run In PL_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF optional genomic PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF pregnant partners PL | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF pregnant partners PL_TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults Phase III_BE_Dutch_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults Phase III_BE_English_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults Phase III_BE_French_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults Phase III_BE_Sponsor Statement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults SRI_BE_Dutch_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults SRI_BE_English_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults SRI_BE_French_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Adults SRI_BE_Sponsor Statement | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partners_BE_Dutch | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partners_BE_English | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partners_BE_French | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partners_BE_Sponsor Statement | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rutiximab Mabthera | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rutiximab Ruxience | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cyclophosphamide | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Doxorubicin | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Prednisone | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Rituximab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Vincristine | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_Dutch_2025-522029-37_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_French_2025-522029-37_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_BE_German_2025-522029-37_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Lay Language_PL_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_LL_English_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SS_English_redacted | 2 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-06 | Belgium | Acceptable with conditions 2026-01-28
|
2026-01-30 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-17 | Acceptable with conditions 2026-01-28
|
2026-02-17 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-11 | Acceptable with conditions 2026-01-28
|
2026-03-11 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-19 | Belgium | Acceptable with conditions | 2026-04-22 |