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New combo aims to boost transplant success in Hodgkin's lymphoma

NCT ID NCT05300282

Disease control Sponsor: Fondazione Italiana Linfomi - ETS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study tests whether adding the immunotherapy drug atezolizumab to standard chemotherapy (BEGEV) helps people with Hodgkin's lymphoma that has returned or not responded to first treatment. About 122 adults aged 18-60 will receive the combination before a stem cell transplant. The goal is to see if the combo leads to more complete remissions and better long-term control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 122 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 18-60 years old (upper limit valid only for phase I). * Histologically confirmed cHL, at first disease relapse or refractory to a first-line treatment or with documented persistent disease at interim positron emission tomography (PET) performed after 2 cycles of first line (ABVD/ABVD like/BEACOPP). * Only one prior systemic therapy for Hodgkin's lymphoma (HL). * First disease relapse or refractory to a first-line treatment. * Eligibility for ASCT. * Performance status (PS) ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale. * Adequate haematological function, unless abnormalities due to underlying disease, at the moment of signing informed consent, defined as follows: * neutrophils \> or = 1.500/mmc and * platelets \> or = 75.000/mmc and * haemoglobin \> or = 8,0 g/dL with transfusion independence * Capacity and willingness to adhere to study visit schedule and specific protocol procedures. * Compliance with effective contraception without interruption, according to physician's judgement, from 28 days before treatment start up to at least 6 months after treatment discontinuation, agreeing not to donate semen/eggs during treatment and for at least 6 months after last treatment dose. Exclusion Criteria: * More than one prior systemic therapy for HL. * Presence of autoimmune disease (based on medical history): systemic lupus erythematosus, autoimmune thyroid disease (Hashimoto's thyroiditis, Basedow's disease), Sjögren's syndrome, glomerulonephritis, multiple sclerosis, rheumatoid arthritis, vasculitis, idiopathic pulmonary fibrosis (includine bronchiolitis obliterans organizing pneumonia) and inflammatory bowel disease (Crohn's disease, ulcerative colitis). * Previous skin toxicity (i.e. Steven-Johnson Sdr, severe skin reactions. * Prior allogeneic stem cell transplantation or prior solid organ transplant. * History of active tubercolosis. * History of leptomeningeal disease. * Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment. * Central nervous system (CNS) involvement by lymphoma. * Major surgery (excluding any lymph node biopsy) within 28 days prior to signing informed consent. * Seropositivity for HBV or evidence of active infection. The following categories may be considered for the study: * HBsAg positive with HBV DNA \< 2000 UI/ml (inactive carriers); HBV DNA \> 2000 UI/ml is criteria of exclusion * HBsAg negative but HBsAb positive * HBsAg negative but HBcAb positive HBsAg positive with HBV DNA \< 2000 UI/ml and HBsAg negative but HBcAb positive will be eligible for the study only if they accept to receive antiviral prophylaxis for all the period of treatment and at least for 12 months after the end of therapy. Treatment should be stopped in case of hepatitis reactivation. - Seropositivity for HCV. Patients with presence of HCV antibody are eligible only if PCR result are negative for HCV RNA * Seropositivity for HIV. * Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail bed) or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics except if for tumor fever) within 2 weeks of the start of Cycle 1. * Life expectancy lower than 6 months. * Prior history of malignancies, other than HL, unless the patient has been free for at least 5 years (exceptions: localized non-melanoma skin cancer ad carcinoma in situ of the cervix). * Any of the following laboratory abnormalities: liver enzymes (AST/SGOT and/or ALT/SGPT) \> 3 fold the upper limit of normal (except of liver involvement by lymphoma); total bilirubin \> 1.5 mg/dL (except for patients with known Gilbert's disease or biliary tree compression by lymphoma masses); creatinine clearance \< 30 mL/min. * Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina. * History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins * Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation * Pregnancy or breastfeeding, or unwillingness to comply with adequate contraception (one negative pregnancy test within 14 days prior to initiation of study treatment required). * Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent the patient from signing the informed consent or which may place the patient at unacceptable risk if participating in the study. Exception to Exclusion: * Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study. * Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study. * Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met: * Rash must cover \< 10% of body surface area * Disease is well controlled at baseline and requires only low-potency topical corticosteroids * No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months * Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease (COPD) exacerbation) are eligible for the study.

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Conditions

The condition(s) this trial relates to.

Hodgkins lymphoma Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsed or refractory Hodgkin's lymphoma

Contacts and locations

Locations

  • A.O. C. Panico - U.O.C Ematologia e Trapianto

    Tricase, Italy

  • A.O.U. Citta della Salute e della Scienza di Torino - Ematologia Universitaria

    Torino, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - SC Ematologia

    Trieste, Italy

  • Azienda USL Piacenza - UOC Ematologia e Centro Trapianti

    Piacenza, Italy

  • Div. di Ematologia - IRCCS Policlinico S. Matteo di Pavia

    Pavia, Italy

  • Divisione di Ematologia - A.O. Ospedali Riuniti Villa Sofia-Cervello

    Palermo, Italy

  • Divisione di Oncologia e dei Tumori immuto-correlati - IRCCS Centro di Riferimento Oncologico di Aviano

    Aviano, Italy

  • Ematologia - ASST Spedali Civili di Brescia

    Brescia, Italy

  • Ematologia - Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova

    Reggio Emilia, Italy

  • Ematologia - Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    Milan, Italy

  • Ematologia - Fondazione del Piemonte per l'Oncologia - IRCCS

    Candiolo, Turin, Italy

  • Ematologia - Ospedale S. Camillo

    Roma, Italy

  • Ematologia - Ospedale Vito Fazzi

    Lecce, Italy

  • IRCCS Istituto Romagnolo per lo studio dei Tumori "Dino Amadori" - IRST S.R.L. - Ematologia

    Meldola, Italy

  • Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione - Policlinico Umberto I - Università "La Sapienza"

    Roma, Italy

  • Istituto Nazionale Tumori - IRCCS Fondazione G. Pascale - UOC Ematologia Oncologica

    Naples, Italy

  • Ospedale degli Infermi di Rimini - U.O. di Ematologia

    Rimini, Italy

  • Ospedale delle Croci - Ematologia

    Ravenna, Italy

  • Policlinico Universitario Campus Bio-Medico - Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare

    Roma, Italy

  • S.C. Ematologia - A.O. SS. Antonio e Biagio e Cesare Arrigo

    Alessandria, Alessandria, 15121, Italy

  • S.C. Ematologia e Trapianto emopoietico - Azienda Ospedaliera S.Giuseppe Moscati

    Avellino, Italy

  • S.C. Oncoematologia - A.O. S. Maria di Terni

    Terni, Italy

  • S.C.Ematologia - A.O.U. Città della Salute e della Scienza di Torino

    Torino, Italy

  • SC Ematologia - ASST Grande Ospedale Metropolitano Niguarda

    Milan, Italy

  • U.O. Ematologia - Istituto Clinico Humanitas

    Rozzano, Italy

  • U.O. Onco-ematologia - Presidio ospedaliero "A. TORTORA"

    Pagani, Italy

  • U.O.C Ematologia - IRCCS Istituto Tumori Giovanni Paolo II

    Bari, Italy

  • Universitа Cattolica S. Cuore - Ematologia

    Roma, Italy