A pilot phase II study with brentuximab vedotin as pre-ASCT induction therapy in relapsed/refractory Hodgkin's lymphoma patients non-responding to IGEV salvage treatment.
Brentuximab vedotin emerged as active single-agent in the treatment of relapsed or refractory HL. Some patients don't reach a complete response after salvage treatment with IGEV (ifosfamide, gemcitabine, vinorelbine) and remain PET positive so the idea is to treat this subset of patients with brentuximab vedotin with the aim of achieving a complete remission before transplant.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Patients with FDG-PET positive after IGEV will be treated with brentuximab vedotin as followed: 1.8 mg/kg every 3 weeks as a 30-minute outpatient IV infusion for a total of 4 cycles of treatment Growth factors may be used at the discretion of investigators but are not routinely advised. Patients with FDG-PET negative after brentuximab vedotin treatment will be addressed to high dose chemotherapy followed by ASCT.
Istituto di Ematologia "L. & A. Seragnoli" , Policlinico S. Orsola Malpighi
Bologna, Italy
Ematologia, IRCCS AOU San Martino-IST
Genova, Italy
Ematologia Ospedale Vito Fazzi
Lecce, Italy
Ematologia e Unità BMT IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Complete response (CR rate)
Complete response will be defined according to recently updated international criteria (Cheson 2007), assuming that a negative PET is defined by DEAUVILLE scores 1 and 2.
Time frame: 1 year and half from the beginning of the study
PFS
Additional study endpoint is final response to Brentuximab vedotin followed by autologous stem cell transplantation (ASCT), in terms of progression free survival (PFS).
Time frame: 2 years and half from the beginning of the study
Neurotoxicity rate
Neurotoxicity of any grade defined as National Cancer Institute Common Terminology Criteria for Adverse Events , version 4.03 (NCI CTCEA, 2010)
Time frame: 1 year half from the beginning of the study
Duration of remission (DR)
Additional study endpoint is final response to Brentuximab vedotin followed by autologous stem cell transplantation (ASCT), in terms of duration of remission (DR).
Time frame: 2 years and half from the beginning of the study
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Università degli Studi di Modena e Reggio Emilia, D.A.I di Medicina diagnostica clinica e sanità pubblica, AOU Policlinico
Modena, Italy
Dipartimento di Oncologia Medica ed Ematologia, Istituto Humanitas
Rozzano, Italy
SC Ematologia - Azienda Ospedaliera AO Città della Salute e della Scienza
Torino, Italy