Brentuximab Vedotin or B-CAP in the Treatment of Older Patients With Newly Diagnosed Classical Hodgkin Lymphoma
NCT ID: NCT02191930
Last Updated: 2024-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2015-09-30
2022-03-16
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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B-CAP
Patients 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
B-CAP
Brentoximab Vedotin only
Patients 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
Brentuximab Vedotin
Interventions
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B-CAP
Brentuximab Vedotin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Prior chemotherapy or radiation for HL except prephase
* Peripheral neuropathy greater than CTC Grade 1
* 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
60 Years
99 Years
ALL
No
Sponsors
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University of Cologne
OTHER
Responsible Party
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Prof. Dr. Peter Borchmann
Prof.
Principal Investigators
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Peter Borchmann, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Cologne
Locations
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1st Dept. of Medicine, Cologne University Hospital
Cologne, , Germany
Countries
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Related Links
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Homepage GHSG
Other Identifiers
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Uni-Koeln-1707
Identifier Type: -
Identifier Source: org_study_id
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