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

University of Modena and Reggio Emilia

Status and phase: Unknown; Phase 2

Conditions: Hodgkin Lymphoma

Treatments: Drug: ABVD; Drug: Brentuximab vedotin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02275598

BV-ABVD

Details and patient eligibility

About

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).

Full description

This is a multicenter pilot phase II trial assessing 2 administrations of Brentuximab vedotin followed by PET scan and subsequent standard treatment with ABVD ± Radiotherapy. 12 patients defined by inclusion and exclusion criteria will be enrolled in one year. All subjects will be followed for disease evaluation every 3 months for one year after end of therapy until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study. For all study procedures patient will be assigned a Unique Subject Identifier (SID) number that will be used to identify the subject during the screening process and throughout study participation. A master log will be maintained of all consented subjects and will document all screening failures (i.e. subjects who are consented but do not meet study eligibility criteria). Study records such as case report forms (CRFs) may be maintained electronically and require the same security and confidentiality as paper. Clinical information will not be released without written permission of the subject/legal representative, except as specified in the informed consent form

Enrollment: 12 patients

Sex: All

Ages: 8 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

BV-ABVD

Experimental group

Description:

Treatment will consist of two three-weekly doses of Brentuximab vedotin, followed by standard treatment, ABVD (3 o 6 cycles q4w).

Treatment:

Drug: ABVD

Drug: Brentuximab vedotin