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RECRUITING
NCT05300282
PHASE1/PHASE2

Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients

Sponsor: Fondazione Italiana Linfomi - ETS

View on ClinicalTrials.gov

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

DRUG

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).

COMBINATION_PRODUCT

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