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

Conditions

Disease, Hodgkin

Keywords

Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Hematologic Diseases, Immunotherapy, Lymphoma, monomethyl auristatin E

Brief summary

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.

Raphaël Steiner, Melody Becnel, Branko Cuglievan, Ranjit Nair, Prachee Singh et al. (15 authors)

Blood2020-11-041 citations

10.1182/blood-2020-138996

Phase 3 study of brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine (A+AVD) versus doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) as front-line treatment for advanced classical Hodgkin lymphoma (HL): Echelon-1 study.

Stephen M. Ansell, Anas Younes, Joseph M. Connors, Andrea Gallamini, Won Seog Kim et al. (15 authors)

Journal of Clinical Oncology2014-05-209 citations

10.1200/jco.2014.32.15_suppl.tps8613

Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study.

Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM.

2013-11-15192 citations

10.1016/s1470-2045(13)70501-1

Interventions

DRUGbrentuximab vedotin

0.6-1.2 mg/kg IV every 2 weeks

DRUGdoxorubicin

25 mg/m2 IV every 2 weeks

DRUGvinblastine

6 mg/m2 IV every 2 weeks

DRUGdacarbazine

375 mg/m2 IV every 2 weeks

DRUGbleomycin

10 units/m2 IV every 2 weeks

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events and laboratory abnormalities	Through 1 month after last dose

Secondary

Measure	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

Countries

Canada, United States

Outcome results

None listed