Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma
BVB
1 other identifier
interventional
70
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2015
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2014
CompletedFirst Posted
Study publicly available on registry
July 16, 2014
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 16, 2022
CompletedAugust 23, 2024
August 1, 2024
6.5 years
July 11, 2014
August 21, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate
after 6 cycles of therapy (at least 18 weeks after start of treatment)
Study Arms (2)
B-CAP
EXPERIMENTALPatients with ECOG of 2 or less (3 or less if caused by HL) and CIRS-G score of 6 or less (overall) and 3 or less per organ system receive 6 cycles of B-CAP (Brentuximab vedotin, cyclophosphamide, doxorubicine, predniso(lo)ne). Cycle length is 21 days
Brentoximab Vedotin only
EXPERIMENTALPatients with CIRS-G score of 7 ore more receive Brentuximab Vedotin as single agent therapy for up to 16 cycles. Cycle length is 21 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Composite lymphoma or nodular lymphocyte- predominant Hodgkin lymphoma (NLPHL)
- Prior chemotherapy or radiation for HL except prephase
- Peripheral neuropathy greater than CTC Grade 1
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
1st Dept. of Medicine, Cologne University Hospital
Cologne, 50924, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Borchmann, Prof.
University Hospital of Cologne
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
July 11, 2014
First Posted
July 16, 2014
Study Start
September 1, 2015
Primary Completion
March 16, 2022
Study Completion
March 16, 2022
Last Updated
August 23, 2024
Record last verified: 2024-08