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

NCT ID: NCT02275598

Last Updated: 2014-10-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2015-03-31

Brief 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).

Detailed 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

Conditions

Hodgkin Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BV-ABVD

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

Group Type: EXPERIMENTAL

Brentuximab vedotin

Intervention Type: DRUG

1.8 mg/kg, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 2

ABVD

Intervention Type: DRUG

Doxorubicin 25 mg/m2 IV, Bleomycin 10,000 units/m2 IV, Vinblastine 6 mg/m2 IV, Dacarbazine 375 mg/m2 IV on days 1-15 of each 28 day cycle. Number of Cycles: 3 or 6 according to initial disease stage.

Interventions

Brentuximab vedotin

1.8 mg/kg, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 2

Intervention Type: DRUG

ABVD

Doxorubicin 25 mg/m2 IV, Bleomycin 10,000 units/m2 IV, Vinblastine 6 mg/m2 IV, Dacarbazine 375 mg/m2 IV on days 1-15 of each 28 day cycle. Number of Cycles: 3 or 6 according to initial disease stage.

Intervention Type: DRUG

Other Intervention Names

Adcetris

Eligibility 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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Modena and Reggio Emilia

OTHER

Sponsor Role: lead

Responsible Party

Massimo Federico, MD

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Massimo Federico, MD

Role: STUDY_CHAIR

Department of Diagnostic, Clinical and Public Health Medicine

Locations

Institute of Hematology and Medical Oncology "L. e A. Seràgnoli" at the University of Bologna

Bologna, , Italy

Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia

Modena, , Italy

Hematology, Azienda Ospedaliera Arcispedale S.Maria Nuova IRCCS

Reggio Emilia, , Italy

Countries

Italy

Other Identifiers

BV-ABVD

Identifier Type: -

Identifier Source: org_study_id