Actively Recruiting
Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients
Led by Fondazione Italiana Linfomi - ETS · Updated on 2026-01-28
122
Participants Needed
32
Research Sites
373 weeks
Total Duration
On this page
Sponsors
F
Fondazione Italiana Linfomi - ETS
Lead Sponsor
R
Roche Pharma AG
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of Atezolizumab Plus BEGEV Regimen in Relapsed or Refractory Hodgkin's Lymphoma Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years (upper age limit applies to phase I)
- Histologically confirmed classical Hodgkin's lymphoma at first relapse or refractory to first-line treatment
- Only one prior systemic therapy for Hodgkin's lymphoma
- Eligible for autologous stem-cell transplantation
- Performance status 0 to 2 on the ECOG scale
- Adequate blood counts: neutrophils 5 1,500/mmc, platelets 5 75,000/mmc, hemoglobin 5 8.0 g/dL without transfusions
- Willing and able to follow study visit schedule and procedures
- Use effective contraception from 28 days before treatment until at least 6 months after treatment ends, and agree not to donate semen or eggs during this time
You will not qualify if you...
- More than one prior systemic therapy for Hodgkin's lymphoma
- Presence of autoimmune diseases such as lupus, autoimmune thyroid disease, Sj�f6gren's syndrome, multiple sclerosis, rheumatoid arthritis, vasculitis, idiopathic pulmonary fibrosis, or inflammatory bowel disease
- Previous severe skin toxicity like Stevens-Johnson syndrome
- Prior allogeneic stem-cell or solid organ transplantation
- History of active tuberculosis or leptomeningeal disease
- Treatment with oral or IV antibiotics within 2 weeks before study treatment
- Central nervous system involvement by lymphoma
- Major surgery (except lymph node biopsy) within 28 days before consent
- Positive hepatitis B or C infection without appropriate antiviral treatment
- Positive HIV infection
- Active infections requiring IV antibiotics or hospitalization within 2 weeks before treatment
- Life expectancy under 6 months
- Prior cancers other than Hodgkin's lymphoma unless disease-free for 5 years (except certain skin or cervical cancers)
- Significant liver or kidney function abnormalities
- Significant heart disease within 3 months before treatment
- History of severe allergic reactions to antibodies or fusion proteins
- Hypersensitivity to components of atezolizumab
- Pregnancy or breastfeeding or unwillingness to use contraception
- Any serious medical or psychiatric condition preventing consent or increasing risk
Exceptions include controlled autoimmune hypothyroidism, controlled type 1 diabetes on insulin, and certain well-controlled skin conditions with limited area and mild treatment requirements.
AI-Screening
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Trial Site Locations
Total: 32 locations
1
S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Alessandria, Italy, 15121
Actively Recruiting
2
Ematologia - Fondazione del Piemonte per l'Oncologia - IRCCS
Candiolo, Turin, Italy
Actively Recruiting
3
S.C. Ematologia e Trapianto emopoietico - Azienda Ospedaliera S.Giuseppe Moscati
Avellino, Italy
Actively Recruiting
4
Divisione di Oncologia e dei Tumori immuto-correlati - IRCCS Centro di Riferimento Oncologico di Aviano
Aviano, Italy
Actively Recruiting
5
U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II
Bari, Italy
Actively Recruiting
6
Ematologia - Ospedale "Monsignor Raffaele Dimiccoli"
Barletta, Italy
Not Yet Recruiting
7
Ematologia - ASST Spedali Civili di Brescia
Brescia, Italy
Actively Recruiting
8
Ospedale S. Maria Goretti - UOC Ematologia con Trapianto
Latina, Italy
Not Yet Recruiting
9
Ematologia - Ospedale Vito Fazzi
Lecce, Italy
Actively Recruiting
10
IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L. - Ematologia
Meldola, Italy
Not Yet Recruiting
11
Azienda Ospedali Riuniti Papardo-Piemonte - S.C. Ematologia
Messina, Italy
Actively Recruiting
12
Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, Italy
Actively Recruiting
13
SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Actively Recruiting
14
Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - UOC Ematologia Oncologica
Naples, Italy
Actively Recruiting
15
U.O. Onco-ematologia - Presidio ospedaliero "A. TORTORA"
Pagani, Italy
Actively Recruiting
16
Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, Italy
Actively Recruiting
17
Div. di Ematologia - IRCCS Policlinico S. Matteo di Pavia
Pavia, Italy
Actively Recruiting
18
Ematologia - Ospedale S. Maria della Misericordia
Perugia, Italy
Actively Recruiting
19
Azienda USL Piacenza - UOC Ematologia e Centro Trapianti
Piacenza, Italy
Actively Recruiting
20
Ospedale delle Croci - Ematologia
Ravenna, Italy
Actively Recruiting
21
Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Actively Recruiting
22
Ospedale degli Infermi di Rimini - U.O. di Ematologia
Rimini, Italy
Not Yet Recruiting
23
Ematologia - Ospedale S. Camillo
Roma, Italy
Actively Recruiting
24
Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza"
Roma, Italy
Actively Recruiting
25
Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Roma, Italy
Actively Recruiting
26
Universitа Cattolica S. Cuore - Ematologia
Roma, Italy
Not Yet Recruiting
27
U.O. Ematologia - Istituto Clinico Humanitas
Rozzano, Italy
Actively Recruiting
28
S.C. Oncoematologia - A.O. S. Maria di Terni
Terni, Italy
Not Yet Recruiting
29
A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria
Torino, Italy
Not Yet Recruiting
30
S.C.Ematologia - A.O.U. Città della Salute e della Scienza di Torino
Torino, Italy
Actively Recruiting
31
A.O. C. Panico - U.O.C Ematologia e Trapianto
Tricase, Italy
Not Yet Recruiting
32
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia
Trieste, Italy
Actively Recruiting
Research Team
U
Uffici Studi FIL
CONTACT
L
Lorenza Randi, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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