A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.

Official Title
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A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma

Conditions
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Disease, Hodgkin

Intervention / Treatment
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* Drug: brentuximab vedotin
* Drug: doxorubicin
* Drug: vinblastine
* Drug: dacarbazine
* Drug: bleomycin
* Drug: brentuximab vedotin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV Measurable disease of at least 1.5 cm Eastern Cooperative Oncology Group performance status <3 Exclusion Criteria: History of another primary malignancy that has not been in remission for at least 3 years Known cerebral/meningeal disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: 1<br>brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) | Drug: brentuximab vedotin<br>* 0.6-1.2 mg/kg IV every 2 weeks<br>* Other names: SGN-35;Drug: doxorubicin<br>* 25 mg/m2 IV every 2 weeks<br>Drug: vinblastine<br>* 6 mg/m2 IV every 2 weeks<br>Drug: dacarbazine<br>* 375 mg/m2 IV every 2 weeks<br>Drug: bleomycin<br>* 10 units/m2 IV every 2 weeks<br>|
| Experimental: 2<br>brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine) | Drug: doxorubicin<br>* 25 mg/m2 IV every 2 weeks<br>Drug: vinblastine<br>* 6 mg/m2 IV every 2 weeks<br>Drug: dacarbazine<br>* 375 mg/m2 IV every 2 weeks<br>Drug: brentuximab vedotin<br>* 0.9-1.2 mg/kg IV every 2 weeks<br>* Other names: SGN-35;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events and laboratory abnormalities |  | Through 1 month after last dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brentuximab vedotin concentration in blood |  | Through 1 month after last dose | 
| Antitherapeutic antibodies in blood |  | Through 1 month after last dose | 
| Best clinical response |  | Through 1 month after last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Hematologic Diseases, Immunotherapy, Lymphoma, monomethyl auristatin E