Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma
- Conditions
- Hodgkin Lymphoma
- Registration Number
- NCT02191930
- Lead Sponsor
- University of Cologne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria (B-CAP):<br><br> - classical Hodgkin Lymphoma<br><br> - Age 60 years or older<br><br> - ECOG performance status = 2 or = 3 if due to HL<br><br> - CIRS-G score of = 6 and = 3 per organ system (except score 4 for eye, ear, nose and<br> throat)<br><br> - Advanced stages: Stage IIB with large mediastinal mass and/or extranodal lesions,<br> stage III or IV disease<br><br> - written informed consent<br><br>Exclusion Criteria (B-CAP):<br><br> - Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)<br><br> - Prior chemotherapy or radiation for HL except prephase<br><br> - Peripheral neuropathy greater than CTC Grade 1<br><br>Inclusion Criteria (BV only):<br><br> - classical Hodgkin Lymphoma<br><br> - Age 60 years or older<br><br> - stage IA to IVB<br><br> - CIRS-G score of = 7 or 4 in one organ system (except score 4 for eye, ear, nose and<br> throat)<br><br> - Patients not eligible to curative poly-chemotherapy at the investigators judgment<br><br> - written informed consent<br><br>Exclusion Criteria (BV only):<br><br> - Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)<br><br> - Prior chemotherapy or radiation for HL except prephase as outlined in the protocol<br><br> - Peripheral neuropathy greater than CTC Grade 1
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate
- Secondary Outcome Measures
Name Time Method