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NCT02191930 Clinical Trial

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

Hodgkin Lymphoma Clinical Trial

— B-CAP  

Official title:
Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma - a GHSG-NLG Intergroup Phase II Trial -

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02191930
Other study ID # B-CAP
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date September 2015
Est. completion date December 2022

Study information
Verified date August 2022
Source University of Cologne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 70
Est. completion date December 2022
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group 60 Years to 99 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• B-CAP

• Brentuximab Vedotin

Locations
Country Name City State
Germany 1st Dept. of Medicine, Cologne University Hospital Cologne

Sponsors (1)
Lead Sponsor Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Objective response rate after 6 cycles of therapy (at least 18 weeks after start of treatment)
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