C5691004 _ A dual-cohort, open-label, phase 2 study of brentuximab vedotin and CHP (A+CHP) in the frontline treatment of subjects with peripheral T-cell lymphoma (PTCL) with less than 10% CD30 expression

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509155-14-00

Acronym

C5691004 / SGN35-032

Enrollment

Registered

2023-12-15

Start date

2021-06-10

Completion date

2026-01-05

Last updated

2026-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral T-cell Lymphoma

Brief summary

ORR per BICR following the completion of study treatment using Revised Response Criteria for Malignant Lymphoma criteria

Detailed description

Complete response rate per BICR, PFS per BICR, OS, DOR per BICR, ORR per BICR, using modified Lugano criteria, Type, incidence, severity, seriousness, and relatedness of adverse events, Laboratory abnormalities

Interventions

DRUGPrednison 5 mg GALEN®

DRUGDOXORUBICINE ACCORD 2 mg/ml

DRUGsolution pour perfusion

DRUGPrednison 50 mg GALEN®

DRUGPrednison 20 mg GALEN®

DRUGBRENTUXIMAB VEDOTIN

DRUGPrednison 10 mg GALEN®

DRUGCyclophosphamide 500 mg Powder for Solution for Injection or Infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR per BICR following the completion of study treatment using Revised Response Criteria for Malignant Lymphoma criteria	—

Secondary

Measure	Time frame
Complete response rate per BICR, PFS per BICR, OS, DOR per BICR, ORR per BICR, using modified Lugano criteria, Type, incidence, severity, seriousness, and relatedness of adverse events, Laboratory abnormalities	—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026