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

October 22, 2014 updated by: Massimo Federico, MD, University of Modena and Reggio Emilia

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bologna, Italy, 40138
        • Institute of Hematology and Medical Oncology "L. e A. Seràgnoli" at the University of Bologna
      • Modena, Italy, 41124
        • Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia
      • Reggio Emilia, Italy, 42100
        • Hematology, Azienda Ospedaliera Arcispedale S.Maria Nuova IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BV-ABVD
Treatment will consist of two three-weekly doses of Brentuximab vedotin, followed by standard treatment, ABVD (3 o 6 cycles q4w).
Drug: Brentuximab vedotin
1.8 mg/kg, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 2
Other Names:
  • Adcetris
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Complete Metabolic Response by FDG-PET
Time Frame: between day +8 and day +15 from second administration of Brentuximab
Complete Metabolic Response will be defined by Deauville score 1, 2, 3.
between day +8 and day +15 from second administration of Brentuximab

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to 4 weeks from the end of full treatment program.
Up to 4 weeks from the end of full treatment program.
Progression Free Survival (PFS)
Time Frame: at 1 year from the end of full treatment program.
at 1 year from the end of full treatment program.
Number of Participants with Adverse Events
Time Frame: from C1D1 of Brentuximab vedotin up to 1 year from the end of full treatment program.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Modena and Reggio Emilia

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

  • Study Chair: Massimo Federico, MD, Department of Diagnostic, Clinical and Public Health Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

October 8, 2014

First Submitted That Met QC Criteria

October 22, 2014

First Posted (ESTIMATE)

October 27, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 22, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BV-ABVD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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