Trials / Recruiting
RecruitingNCT07215585
AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 420 (estimated)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 65 Years – 130 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD0486 | Bispecific monoclonal IgG4 antibody |
| DRUG | 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 |
Timeline
- Start date
- 2025-11-11
- Primary completion
- 2030-06-10
- Completion
- 2033-07-28
- First posted
- 2025-10-10
- Last updated
- 2026-03-20
Locations
45 sites across 11 countries: Australia, Belgium, Brazil, Canada, China, Hong Kong, Japan, Poland, South Korea, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07215585. Inclusion in this directory is not an endorsement.