NCT01476410

Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma

A Phase II Trial of Sequential SGN-35 Therapy With Adriamycin, Vinblastine, and Dacarbazine (S-AVD) for Older Patients With Untreated Hodgkin Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well giving brentuximab vedotin together with combination chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin lymphoma (HL). Monoclonal antibody-drug conjugates, such as brentuximab vedotin, can block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as doxorubicin hydrochloride, vinblastine, and dacarbazine (AVD), work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving brentuximab vedotin, doxorubicin hydrochloride, vinblastine, and dacarbazine together may kill more cancer cells.

Detailed description

LEAD IN: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.

Conditions

• Adult Lymphocyte Depletion Hodgkin Lymphoma
• Adult Lymphocyte Predominant Hodgkin Lymphoma
• Adult Mixed Cellularity Hodgkin Lymphoma
• Adult Nodular Sclerosis Hodgkin Lymphoma
• Stage II Adult Hodgkin Lymphoma
• Stage III Adult Hodgkin Lymphoma
• Stage IV Adult Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	Given IV
DRUG	doxorubicin hydrochloride	Given IV
DRUG	vinblastine	Given IV
DRUG	dacarbazine	Given IV
PROCEDURE	quality-of-life assessment	Ancillary studies
GENETIC	DNA analysis	Optional correlative studies
GENETIC	RNA analysis	Optional correlative studies
RADIATION	fludeoxyglucose F 18	Correlative studies
PROCEDURE	positron emission tomography	Correlative studies
OTHER	laboratory biomarker analysis	Optional correlative studies
OTHER	immunohistochemistry staining method	Optional correlative studies
GENETIC	polymorphism analysis	Optional correlative studies

Timeline

• Start date: 2011-11-01
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2011-11-22
• Last updated: 2020-02-17

Locations

7 sites across 1 country: United States