Actively Recruiting
Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients.
Led by Fondazione Italiana Linfomi - ETS · Updated on 2025-12-24
28
Participants Needed
18
Research Sites
255 weeks
Total Duration
On this page
Sponsors
F
Fondazione Italiana Linfomi - ETS
Lead Sponsor
J
Janssen-Cilag S.p.A.
Collaborating Sponsor
AI-Summary
What this Trial Is About
It is an open-label, multicenter, phase II, single arm trial to Evaluate Activity and Safety of Daratumumab in combination with Bortezomib and Dexamethasone in patients about 28 patients with Relapsed or Refractory Plasmablastic lymphoma.
CONDITIONS
Official Title
Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed plasmablastic lymphoma with CD38 expression of at least 5% by immunohistochemistry
- Relapsed or refractory plasmablastic lymphoma after at least one line of conventional-dose chemotherapy, with or without autologous stem cell transplantation
- Patients not eligible for salvage autologous or allogeneic transplantation
- ECOG Performance Status of 3 or less
- Age 18 years or older
- HIV-positive patients must have infection responsive to ongoing combination antiretroviral therapy
- At least one measurable disease lesion detectable by imaging, meeting size criteria
- Women of childbearing potential and men must agree to use effective contraception during and after treatment
- Ability to understand and voluntarily sign informed consent
- Ability to adhere to study visit schedule and protocol requirements
You will not qualify if you...
- Diagnosis other than plasmablastic lymphoma or CD38 expression less than 5%
- Central nervous system involvement
- Known allergic or severe reactions to study drugs or related products
- Receipt of any anti-cancer therapy within 14 days before first study dose
- Concomitant Kaposi sarcoma with visceral involvement
- Seropositive for hepatitis B or hepatitis C without sustained virologic response
- History of other cancers within 5 years except certain non-melanoma skin tumors and in situ carcinomas
- Active or chronic infectious diseases requiring systemic treatment (except controlled HIV)
- Active COVID-19 infection
- Abnormal laboratory values including low blood counts or elevated liver enzymes beyond specified limits
- Clinically significant cardiac disease including recent myocardial infarction or severe arrhythmia
- Other uncontrolled significant medical conditions
- Significant neurological, psychiatric, endocrine, metabolic, immunologic, or hepatic diseases affecting consent or participation
- Breastfeeding women or positive pregnancy test at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona
Ancona, Italy, 60126
Actively Recruiting
2
Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati
Aviano, Italy
Actively Recruiting
3
A.O. Spedali Civili di Brescia - Ematologia
Brescia, Italy
Actively Recruiting
4
Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
Florence, Italy, 50141
Actively Recruiting
5
Milano - ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Miano, Italy
Actively Recruiting
6
Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia
Milan, Italy
Actively Recruiting
7
Monza - ASST MONZA Ospedale S. Gerardo - Ematologia
Monza, Italy
Actively Recruiting
8
Napoli - AORN - Azienda Ospedaliera dei Colli Monald - U.O.C. Oncologia
Naples, Italy
Active, Not Recruiting
9
U.O. Ematologia AO di Padova
Padova, Italy, 35128
Actively Recruiting
10
A.O. Universitaria Policlinico Giaccone Di Palermo
Palermo, Italy, 90127
Not Yet Recruiting
11
Ematologia IRCCS Policlinico S. Matteo di Pavia
Pavia, Italy
Actively Recruiting
12
AO Arcispedale S.Maria Nuova Ematologia
Reggio Emilia, Italy
Actively Recruiting
13
Roma - IRCCS Spallanzani - Servizio di Ematologia in malattie infettive
Roma, Italy
Not Yet Recruiting
14
Roma - Ospedale S. Camillo - Ematologia
Roma, Italy
Actively Recruiting
15
A.O. S. Maria di Terni - S.C. Oncoematologia
Terni, Italy
Not Yet Recruiting
16
A.O. Universitaria Citta' Della Salute E Della Scienza Di Torino
Torino, Italy, 10126
Actively Recruiting
17
Struttura Complessa di Ematologia PO TREVISO
Treviso, Italy, 31100
Actively Recruiting
18
AOU Integrata di Verona - U.O. Ematologia
Verona, Italy, 37134
Actively Recruiting
Research Team
A
Agostino La Porta, Dr.
CONTACT
L
Lorenza Randi, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here