Studies biomarkers that may predict response to treatment in relapsed large B-cell lymphoma
Looks for markers that may predict treatment response in adults with relapsed lymphoma.
Plain-language title generated from the registry record
Registry title: Predictive Biomarkers Including miRNA-based Tumor Signatures in Diffuse Large B Cell Lymphoma (R/R DLBCL) (MIMOSA)
Key facts
- Where
- Naples and Roma, ItalySee the 3 sites
Where in Italy
- Istituto Nazionale Tumori - Fondazione "G.Pascale", IRCCSNaples, ItalyNo longer taking part
- Fonadazione Policlinico Universitario A. GemelliRoma, ItalyNo longer taking part
- Istituti Fisioterapici Ospitalieri -Istituto Regina ElenaRoma, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT05746858
- Record updated
- 28 February 2023
- Original description
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:Read full original descriptionShow less
Deciphering the Biology of Relapsed/Refractory Diffuse Large B Cell Lymphoma (R/R DLBCL) Subtypes: Identification of Predictive Biomarkers Including miRNA-based Tumor Signatures to Optimize Sequential Treatment Decisions. (MIMOSA)
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.
Inclusion: 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); No concomitant active cancers or others life-threatening conditions that can compromise chemotherapy treatment; Available FFPE and fresh tumor tissue (excisional biopsy, Tru-cut microhistology); Informed consent to treatment and use of biologic materials for studies related to the present proposal.
Exclusion: Patients with concomitant active solid tumors or others clinical conditions that can compromise chemotherapy treatment or negatively influence the prognosis; No measurable and/or evaluable disease; Known history of HIV seropositive status. HIV testing will be performed at screening; Age ≤ 18 years; Diagnosis of follicular lymphoma grade 3b, lymphoblastic lymphoma, Burkitt lymphoma or primary mediastinal lymphoma; Ineligible for first-line and/or salvage chemo-immunotherapies.