Recruiting
Phase 3

R-mini-CHOP & AZD0486

Sponsor:

AstraZeneca

Code:

NCT07215585

Conditions

Large B-cell Lymphoma

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Interventions

AZD0486

R-mini-CHOP

Study Details

Brief 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.

Conditions

Large B-cell Lymphoma

Study ID

NCT07215585

Start date

Nov 11, 2025

Status verified date

Jun, 2026

Completion date

Jul 28, 2033

Anticipated

Primary completion date

Jun 10, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65 - 70+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • 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.

  • 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.

Study Design

Enrollment

420 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase III Arm A: R-mini-CHOP and AZD0486

2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP3D.

active comparator: Phase III Arm B: R-mini-CHOP

6 cycles of R-mini-CHOP per SoC regimen.

experimental: Safety Run in: R-mini-CHOP and AZD0486

2 cycles of R-mini-CHOP followed sequentially by multiple cycles of AZD0486 at RP2D.

Interventions

AZD0486

Bispecific monoclonal IgG4 antibody

R-mini-CHOP

Intravenous administration: Rituximab 375 mg/m2, Cyclophosphamide 400 mg/m2, Doxorubicin 25 mg/m2, Vincristine 1 mg, and Oral administration: Prednisone 40 mg/m2

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 ]
  • 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 ]
  • SRI - Determination of the recommended Phase III dose (RP3D) [ Time Frame: 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. [ Time Frame: Up to 7 years ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Calgary, Alberta, Canada, T2N 5G2

Research Site

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

More Information

Sponsor

AstraZeneca

Last update posted

Jun 18, 2026

Last verified

Jun, 2026

Keywords

  • Large B-cell Lymphoma
  • LBCL
  • AZD0486
  • CD3
  • CD19
  • TCE
  • B-cell malignancies
  • Soundtrack-D2

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-06-18.