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Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients
Sponsor: Fondazione Italiana Linfomi - ETS
Summary
The phase I part (safety assessment of the combination treatment) is aimed at determining the MTD of atezolizumab when combined with BEGEV schedule. 6-18 patients enrolled in this part will be treated with atezolizumab in combination with BEGEV regimen every 3 weeks for 4 cycles. Patients without a DLT in the first cycle and without disease progression after cycle 2, will undergo stem cell mobilization with 3-4 cycle of A-BEGEV + granulocyte colony-stimulating factor (G-CSF) and subsequently receive a myeloablative therapy followed by ASCT. The phase IIb part (expansion cohort) plans to randomize 122 patients in two arms (A and B, 61 per arm): 1. arm A will receive the BEGEV regimen followed by ASCT for patients achieving CR. 2. arm B will receive combination treatment with Atezolizumab and BEGEV regimen followed for patients reaching CR by ASCT plus a consolidation with 6 doses of atezolizumab at 1200 mg every 4 weeks. After the last treatment date of the last patient (LPLT), the phase IIb will be ended. A long term follow up will start, in order to better assess patients' prognosis. All evaluable patients from phase I and phase IIb study will enter in the long term follow up phase and will be followed for 18 months.
Official title: A Phase I/II b (Randomized Controlled) Study of Atezolizumab Combined to BEGEV Regimen as First Salvage Treatment in Patients With Relapsed or Refractory Hodgkin's Lymphoma Candidate to Autologous Stem-Cell Transplantation
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
122
Start Date
2023-02-27
Completion Date
2030-04-27
Last Updated
2026-01-28
Healthy Volunteers
No
Interventions
Atezolizumab
In phase I study: Atezolizumab will be administered until the determination of its MTD when combined with BEGEV schedule. In phase II b study - arm A (standard): Atezolizumab will not be administered. In phase II b study - arm B (experimental): Atezolizumab will be administered at MTD determined in phase I study plus BEGEV regimen (at dosages performed by local practice).
BEGEV
In phase I study: Atezolizumab will be administered until the determination of its MTD when combined with BEGEV schedule. In phase II b study - arm A (standard): only BEGEV will be administered. In phase II b study - arm B (experimental): BEGEV regimen will be administered in combination with Atezolizumab at MTD determined in phase I.
Locations (32)
S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Alessandria, Italy
Ematologia - Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, Turin, Italy
S.C. Ematologia e Trapianto emopoietico - Azienda Ospedaliera S.Giuseppe Moscati
Avellino, Italy
Divisione di Oncologia e dei Tumori immuto-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
Aviano, Italy
U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy
Ematologia - Ospedale "Monsignor Raffaele Dimiccoli"
Barletta, Italy
Ematologia - ASST Spedali Civili di Brescia
Brescia, Italy
Ospedale S. Maria Goretti - UOC Ematologia con Trapianto
Latina, Italy
Ematologia - Ospedale Vito Fazzi
Lecce, Italy
IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L. - Ematologia
Meldola, Italy
Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia
Messina, Italy
Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Italy
SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - UOC Ematologia Oncologica
Naples, Italy
U.O. Onco-ematologia - Presidio ospedaliero "A. TORTORA"
Pagani, Italy
Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, Italy
Div. di Ematologia - IRCCS Policlinico S. Matteo di Pavia
Pavia, Italy
Ematologia - Ospedale S. Maria della Misericordia
Perugia, Italy
Azienda USL Piacenza - UOC Ematologia e Centro Trapianti
Piacenza, Italy
Ospedale delle Croci - Ematologia
Ravenna, Italy
Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Ospedale degli Infermi di Rimini - U.O. di Ematologia
Rimini, Italy
Ematologia - Ospedale S. Camillo
Roma, Italy
Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza"
Roma, Italy
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Roma, Italy
Universitа Cattolica S. Cuore - Ematologia
Roma, Italy
U.O. Ematologia - Istituto Clinico Humanitas
Rozzano, Italy
S.C. Oncoematologia - A.O. S. Maria di Terni
Terni, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, Italy
S.C.Ematologia - A.O.U. Città della Salute e della Scienza di Torino
Torino, Italy
A.O. C. Panico - U.O.C Ematologia e Trapianto
Tricase, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
Trieste, Italy