Brentuximab Vedotin Followed by ABVD in Patients With Previously Untreated Hodgkin Lymphoma

• Status: Unknown status
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy of two three-weekly 1.8 mg/kg Brentuximab vedotin administrations in untreated patients with Hodgkin Lymphoma (HL).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Modena and Reggio Emilia
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Antibodies, Monoclonal; Brentuximab Vedotin

Criteria

Inclusion Criteria:

• Previously-untreated patients with classical Hodgkin Lymphoma according to the World Health Organisation (WHO) classification

• Histologically confirmed CD30+ HL

• Stage IA, IIA, IIIA

• Absence of bulky disease

• FDG-PET at baseline

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1

• Life expectancy > 6 months.

• Age 18-70 years.

• Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.

• Females of childbearing potential must have a negative pregnancy test result within three days of enrollment. All patients must agree to use effective contraceptive methods (one for male and two for female) during the course of the study and for 6 months following the end of full treatment (Brentuximab vedotin + ABVD +/- Radiotherapy).

• Written informed consent.

• Required baseline laboratory data:

Absolute neutrophil count ≥ 1000/μl Platelet count ≥ 50.000/ μl Serum bilirubin ≤ 1.5 times ULN Serum creatinine ≤ 1.5 times ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN

Exclusion Criteria:

• Peripheral neuropathy > Grade 1

• Histologic diagnosis different from Hodgkin Lymphoma

• Compressive symptoms

• Patients previously treated with any anti-CD30 antibody

• Known human immunodeficiency virus (HIV) positive

• Known hepatitis B surface antigen-positive, or known or suspected infection active hepatitis C

• Patients with signs or symptoms of progressive multifocal leukoencephalopathy (PML)

• Patients with known cerebral/meningeal disease.