Status:
COMPLETED
Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma
Lead Sponsor:
University of Cologne
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
60-99 years
Phase:
PHASE2
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 chemothe...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 16 2022
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02191930
Start Date
September 1 2015
End Date
March 16 2022
Last Update
August 23 2024
Active Locations (1)
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1
1st Dept. of Medicine, Cologne University Hospital
Cologne, Germany, 50924