EUCTR2012-002012-46-IT
Active, not recruiting
Not Applicable
A pilot phase II study to assess the efficacy of Brentuximab Vedotin administered sequentally with ABVD chemotherapy in patients with untreated Hodgkin Lymphoma
AZIENDA OSPEDALIERA POLICLINICO DI MODENA0 sitesJune 21, 2012
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AZIENDA OSPEDALIERA POLICLINICO DI MODENA
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men or women aged 18\-70 years at time of study entry • Previously untreated patients with histologically confirmed CD30\+ Hodgkin Lymphoma according to the World Health Organisation (WHO) classification • Stage IA, IIA, IIIA • Absence of bulky disease defined by nodal masses greater than 10 cm in their transverse diameter as a node or nodal mass of 10 cm or greater or a mediastinal mass greater than one\-third of the internal transverse diameter of the thorax at the level of T5/T6 (Cotswolds Meeting) • ECOG performance status of 0\-1 • Life expectancy \> 6 months. • Informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 12
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Peripheral neuropathy \> Grade 1 • Histologic diagnosis different from Hodgkin Lymphoma • Compressive symptoms caused by the presence of Lymphoma • Patients who have been treated previously with any anti\-CD30 antibody • Known hypersensitivity to any recombinant proteins, murine proteins, or excipients contained in the Brentuximab Vedotin formulation • Known human immunodeficiency virus (HIV) positive • Known hepatitis B surface antigen\-positive, or known or suspected active hepatitis C infection • Patients with congestive heart failure, Class III or IV, by the NYHA criteria • Patients with known active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of Brentuximab Vedotin • Patients with signs or symptoms of progressive multifocal leukoencephalopathy (PML) • Patients with known cerebral/meningeal disease. • Patients who are pregnant or lactating and breastfeeding.
Outcomes
Primary Outcomes
Not specified
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