Hodgkin Lymphoma
Conditions
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
Interventions
DRUGB-CAP
DRUGBrentuximab Vedotin
Sponsors
University of Cologne
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate | after 6 cycles of therapy (at least 18 weeks after start of treatment) |
Countries
Germany
Outcome results
None listed