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

• Status: Active, not recruiting
• Trial end date: 2022-04-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Cologne
• Treatments: Antibodies, Monoclonal; Brentuximab Vedotin; Cyclophosphamide; Doxorubicin

Criteria

Inclusion Criteria (B-CAP):

• classical Hodgkin Lymphoma

• Age 60 years or older

• ECOG performance status ≤ 2 or ≤ 3 if due to HL

• CIRS-G score of ≤ 6 and ≤ 3 per organ system (except score 4 for eye, ear, nose and throat)

• Advanced stages: Stage IIB with large mediastinal mass and/or extranodal lesions, stage III or IV disease

• written informed consent

Exclusion Criteria (B-CAP):

• Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)

• Prior chemotherapy or radiation for HL except prephase

• Peripheral neuropathy greater than CTC Grade 1

Inclusion Criteria (BV only):

• classical Hodgkin Lymphoma

• Age 60 years or older

• stage IA to IVB

• CIRS-G score of ≥ 7 or 4 in one organ system (except score 4 for eye, ear, nose and throat)

• Patients not eligible to curative poly-chemotherapy at the investigators judgment

• written informed consent

Exclusion Criteria (BV only):

• Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)

• Prior chemotherapy or radiation for HL except prephase as outlined in the protocol

• Peripheral neuropathy greater than CTC Grade 1