Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 60Years
All Genders
NCT05300282

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

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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.

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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

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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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