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

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Seagen

Status and phase

Completed
Phase 1

Conditions

Disease, Hodgkin

Treatments

Drug: bleomycin
Drug: doxorubicin
Drug: dacarbazine
Drug: brentuximab vedotin
Drug: vinblastine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01060904
SGN35-009

Details and patient eligibility

About

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.

Enrollment

51 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

51 participants in 2 patient groups

1
Experimental group
Description:
brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
Treatment:
Drug: vinblastine
Drug: bleomycin
Drug: brentuximab vedotin
Drug: brentuximab vedotin
Drug: dacarbazine
Drug: doxorubicin
2
Experimental group
Description:
brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)
Treatment:
Drug: vinblastine
Drug: brentuximab vedotin
Drug: brentuximab vedotin
Drug: dacarbazine
Drug: doxorubicin

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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