Condition: Relapsed or Refractory Hodgkin's Lymphoma · Sponsor: Fondazione Italiana Linfomi - ETS
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.
This description comes directly from the study's public registry record.
Uffici Studi FIL · 0131033153 · startup@filinf.it
Lorenza Randi, Dr. · 0131033153 · lrandi@filinf.it
Always discuss trial participation with your own doctor first.
| S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo | Alessandria, Alessandria, Italy | Recruiting |
| Ematologia - Fondazione del Piemonte per l'Oncologia - IRCCS | Candiolo, Turin, Italy | Recruiting |
| S.C. Ematologia e Trapianto emopoietico - Azienda Ospedaliera S.Giuseppe Moscati | Avellino, Italy | Recruiting |
| Divisione di Oncologia e dei Tumori immuto-correlati - IRCCS Centro di Riferimento Oncologico di Aviano | Aviano, Italy | Recruiting |
| U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II | Bari, Italy | Recruiting |
| Ematologia - Ospedale "Monsignor Raffaele Dimiccoli" | Barletta, Italy | Not Yet Recruiting |
| Ematologia - ASST Spedali Civili di Brescia | Brescia, Italy | Recruiting |
| Ospedale S. Maria Goretti - UOC Ematologia con Trapianto | Latina, Italy | Not Yet Recruiting |
| Ematologia - Ospedale Vito Fazzi | Lecce, Italy | Recruiting |
| IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L. - Ematologia | Meldola, Italy | Not Yet Recruiting |
| Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia | Messina, Italy | Recruiting |
| Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano | Milan, Italy | Recruiting |
+ 20 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05300282