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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02275598
Recruitment Status : Unknown
Verified October 2014 by Massimo Federico, MD, University of Modena and Reggio Emilia.
Recruitment status was:  Active, not recruiting
First Posted : October 27, 2014
Last Update Posted : October 27, 2014
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Massimo Federico, MD, University of Modena and Reggio Emilia

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).

Condition or disease Intervention/treatment Phase
Hodgkin Lymphoma Drug: Brentuximab vedotin Drug: ABVD Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
Study Start Date : April 2013
Actual Primary Completion Date : November 2013
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

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 Name: 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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Overall Response Rate (ORR) [ Time Frame: Up to 4 weeks from the end of full treatment program. ]
  2. Progression Free Survival (PFS) [ Time Frame: at 1 year from the end of full treatment program. ]
  3. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02275598

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Institute of Hematology and Medical Oncology "L. e A. Seràgnoli" at the University of Bologna
Bologna, Italy, 40138
Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia
Modena, Italy, 41124
Hematology, Azienda Ospedaliera Arcispedale S.Maria Nuova IRCCS
Reggio Emilia, Italy, 42100
Sponsors and Collaborators
University of Modena and Reggio Emilia
Millennium Pharmaceuticals, Inc.
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Study Chair: Massimo Federico, MD Department of Diagnostic, Clinical and Public Health Medicine

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Responsible Party: Massimo Federico, MD, Full Professor, University of Modena and Reggio Emilia Identifier: NCT02275598     History of Changes
Other Study ID Numbers: BV-ABVD
First Posted: October 27, 2014    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs