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

Hodgkin Lymphoma Clinical Trial

Official title:

A Pilot Phase II Study To Assess The Efficacy Of Brentuximab Vedotin Administered Sequentially With ABVD Chemotherapy In Patients With Untreated Hodgkin Lymphoma.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02275598
• Other study ID #: BV-ABVD
• Status: Active, not recruiting
• Phase: Phase 2
• First received: October 8, 2014
• Last updated: October 22, 2014
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: October 2014
• Source: University of Modena and Reggio Emilia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12
• Est. completion date: March 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
Italy	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Modena and Reggio Emilia	Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Complete Metabolic Response by FDG-PET	Complete Metabolic Response will be defined by Deauville score 1, 2, 3.	between day +8 and day +15 from second administration of Brentuximab	No
Secondary	Overall Response Rate (ORR)		Up to 4 weeks from the end of full treatment program.	No
Secondary	Progression Free Survival (PFS)		at 1 year from the end of full treatment program.	No
Secondary	Number of Participants with Adverse Events	All serious and on-serious adverse events will be assessed	from C1D1 of Brentuximab vedotin up to 1 year from the end of full treatment program.	Yes