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

Study Overview
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Brief Summary
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The purpose of this trial is to determine 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 Progression-free survival (PFS) 3 years after registration

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

Conditions
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Hodgkin Lymphoma

Intervention / Treatment
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* Drug: B-CAP
* Drug: Brentuximab Vedotin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B-CAP<br>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 | Drug: B-CAP<br> <br> * Other names: Predniso(lo)ne;|
| Experimental: Brentoximab Vedotin only<br>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 | Drug: Brentuximab Vedotin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate |  | after 6 cycles of therapy (at least 18 weeks after start of treatment) |