NCT05006664

Brentuximab Vedotin in Combination With CHEP in Patient With PTCL

A Phase II Open Label Study of Brentuximab Vedotin in Combination With CHEP in Patients With Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Czech Lymphoma Study Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase II Open Label Study of Brentuximab Vedotin in Combination with CHEP in Patients with Previously Untreated CD30-expressing Peripheral T-cell Lymphomas (PTCL)

Detailed description

Efficacy assessments will be made according to the revised response criteria for malignant lymphoma based on the guidelines of the Lugano Classification (as reported by Cheson B et al. 2014) and will be based on investigator assessment Efficacy will be evaluated in terms of CR rate, ORR, PFS, EFS, OS. The safety and tolerability of study treatment will be evaluated by means of AE reports (nature, severity, frequency, causality), performance status, physical examinations, ECG and laboratory safety evaluations.

Conditions

• Lymphoma, T-Cell, Peripheral

Interventions

Type	Name	Description
DRUG	Adcetris 50 MG Injection	Treatment by study drug Brentuximab Vedotin (Adcetris) in combination with CHEP.
DRUG	Endoxan	Treatment by study drug Cyclophosphamide (Endoxan) in combination.
DRUG	Doxorubicin	Treatment by study drug Doxorubicin in combination.
DRUG	Etoposide	Treatment by study drug Etoposide in combination.
DRUG	Prednisone tablet	Treatment by study drug Prednisone in combination.

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2021-08-16
• Last updated: 2021-09-01

Locations

7 sites across 1 country: Czechia