Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma

Phase 2

Completed

• Conditions: Hodgkin Lymphoma
• Interventions: Drug: B-CAP; Drug: Brentuximab Vedotin

• Registration Number: NCT02191930
• Lead Sponsor: University of Cologne

Brief Summary

The purpose of this trial is to determine

1. Objective response rate (ORR), defined as the proportion of patients having CR, CRr or PR in the centrally reviewed restaging after six cycles of chemotherapy

2. Progression-free survival (PFS) 3 years after registration

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-14
• Study First Posted: 2014-07-16
• Study Start: 2015-09
• Primary Completion: 2022-03-16
• Study Completion: 2022-03-16
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-21
• Last Update Posted: 2024-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B-CAP	B-CAP	Patients with ECOG of 2 or less (3 or less if caused by HL) and CIRS-G score of 6 or less (overall) and 3 or less per organ system receive 6 cycles of B-CAP (Brentuximab vedotin, cyclophosphamide, doxorubicine, predniso(lo)ne). Cycle length is 21 days
Brentoximab Vedotin only	Brentuximab Vedotin	Patients with CIRS-G score of 7 ore more receive Brentuximab Vedotin as single agent therapy for up to 16 cycles. Cycle length is 21 days

Primary Outcome Measures

Name	Time	Method
Objective response rate	after 6 cycles of therapy (at least 18 weeks after start of treatment)

Trial Locations

Locations (1)

1st Dept. of Medicine, Cologne University Hospital; 🇩🇪 Cologne, Germany