Previously untreated patients with classical Hodgkin Lymphoma according to the World Health Organisation (WHO) classification MedDRA version: 14.1 Level: LLT Classification code 10020205 Term: Hodgins System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: ADCETRIS
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Brentuximab vedotin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate FDG-PET modification after two three-weekly Brentuximab vedotin administrations in untreated patients;Secondary Objective: • Clinical benefit to the full treatment program with Brentuximab vedotin followed by ABVD +/- RT in terms of response and progression free survival (PFS) • Safety of Brentuximab vedotin;Primary end point(s): Response to two three-weekly 1.8 mg/kg Brentuximab vedotin administrations defined as reduction of Deauville score or, in case of no change in Deauville score, as any reduction in SUV intensity compared to maximum basal SUV.;Timepoint(s) of evaluation of this end point: This end point will be evaluated day +8-+15 of cycle 2 of Brentuxiamb vedotin | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Final response to Brentuximab vedotin followed by ABVD +/- RT, in terms of complete response rate (CRR) and progression free survival (PFS). 2) Safety of Brentuximab vedotin;Timepoint(s) of evaluation of this end point: 1)one month after full treatment for CRR and from the day of treatment start to the date of progressive disease, within one year after the end of treatment for the PFS 2)from the day of treatment start to the end of the study. | — |
Countries
Italy
Contacts
Public ContactLABORATORIO RICERCA CLINICA
AZIENDA OSPEDALIERA POLICLINICO DI MODENA
Outcome results
None listed