About this trial
The goal of this study is to identify biomarkers that will predict outcome to standard and targeted therapies in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The specific aims of the present project are:
1. To explore associations between expression of target antigens on surface of neoplastic cells of DLBCL patients and response to target therapies 2. To identify specific miRNA signatures as predictors of response to upfront and salvage immune-chemotherapies in DLBCL patients. 3. To refine the diagnosis and molecular profiling of DLBCL, and to provide biological information of prognostic relevance in the setting of innovative treatments of patients with DLBCL.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of DLBCL and RR-DLBCL;
Age>18 years;
Eligibility for first-line and/or salvage chemo-immunotherapies as above specified;
Measurable and/or evaluable disease (at least one bi-dimensionally measurable lesion on imaging scan defined as >1.5 cm in its longest dimension);
Disqualifiers
Diagnosis of follicular lymphoma grade 3b, lymphoblastic lymphoma, Burkitt lymphoma or primary mediastinal lymphoma;
Age ≤ 18 years;
Ineligible for first-line and/or salvage chemo-immunotherapies;
No measurable and/or evaluable disease;
Trial population
a) newly diagnosed DLBCL patients treated with: i) standard R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) and DA-EPOCH -R regimens; ii) frontline Pola-R-CHP (Polatuzumab vendotin, Rituximab, Cyclophosphamide, Doxorubicin, Prednisone) as approved by the European Medicine Agency-CHMP (24.03.2022); b) RR-DLBCL patients receiving salvage treatments including: a) R-Pola-Benda (Rituximab, Polatuzumab vendotin, Bendamustine); b) Lenalidomide-Tafasitamab; c) Anti-CD19 CAR-T cells; d) bispecific antibodies (e.g. Glofitamab).
Trial design
Cohort
Other
Treatments tested in this trial
no intervention (observational study)
Other interventionNo intervention (observational study)
Treatment groups
Trial outcomes
Primary outcomes
Complete remission
Complete remission rates according to miRNA signatures, expression of target antigens, mutational status
Sponsors and contacts
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead sponsor
Istituti Fisioterapici Ospitalieri
Collaborator
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Collaborator
This trial is not recruiting at the moment. You can still explore other options: