Status:
UNKNOWN
Brentuximab Vedotin Followed by ABVD in Patients With Previously Untreated Hodgkin Lymphoma
Lead Sponsor:
University of Modena and Reggio Emilia
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
8-70 years
Phase:
PHASE2
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 in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02275598
Start Date
April 1 2013
End Date
March 1 2015
Last Update
October 27 2014
Active Locations (3)
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1
Institute of Hematology and Medical Oncology "L. e A. Seràgnoli" at the University of Bologna
Bologna, Italy, 40138
2
Department of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia
Modena, Italy, 41124
3
Hematology, Azienda Ospedaliera Arcispedale S.Maria Nuova IRCCS
Reggio Emilia, Italy, 42100