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
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

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)

External Links

•   Homepage GHSG