RecruitingPhase 2NCT06835530

A Combination of Rituximab and CC-99282 as Front-line Therapy for Older Frail Patients With Diffuse Large B-cells Non-Hodgkin Lymphoma Evaluated With a Simplified Geriatric Assessment (sGA): a Phase II Study of the Fondazione Italiana Linfomi (FIL)

Sponsor

Fondazione Italiana Linfomi - ETS

Enrollment

47 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Non-Hodgkin Lymphoma

Summary

Prospective, multicenter, single arm, phase II study, to evaluate the efficacy of the combination rituximab-golcadomide as a chemo free approach in a population of older patients with new diagnosis of DLBCL, defined as frail according to a sGA evaluation and not candidate for the standard R-CHOP (or R-CHOP like) treatments.

Eligibility

Min Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study tests whether the combination of rituximab (an antibody that targets B-cell lymphoma) and CC-99282 (an oral immune-modulating drug) can safely and effectively treat older, frail patients with a newly diagnosed aggressive type of B-cell lymphoma (DLBCL) who cannot tolerate intensive standard chemotherapy. **You may be eligible if...** - You have been newly diagnosed with diffuse large B-cell lymphoma (DLBCL), confirmed by biopsy - You have not received any prior treatment for this lymphoma - You are age 80 or older, with limitations in daily activities, multiple health conditions, or age 75–79 with specific frailty criteria - You are not able to tolerate intensive chemotherapy regimens **You may NOT be eligible if...** - You have received prior lymphoma treatment - You have active brain lymphoma involvement - You have serious heart, liver, or kidney problems - You are pregnant or unable to use effective contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRituximab + Golcadomide (CC-99282)

A combination of Rituximab and CC-99282 as front-line therapy for older frail patients with Diffuse Large B-cells non-Hodgkin Lymphoma evaluated with a simplified Geriatric Assessment (sGA).

Locations(20)

AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria - SCDU Ematologia

Alessandria, Italy

AOU Ospedali Riuniti - Clinica di Ematologia

Ancona, Italy

Azienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e trapianto emopoietico

Avellino, Italy

Ospedale IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuno-correlati

Aviano, Italy

ASST Spedali Civili di Brescia - Ematologia

Brescia, Italy

Azienda Ospedaliera Universitaria Careggi -Unità Funzionale di Ematologia

Florence, Italy

ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

Milan, Italy

Fondazione IRCCS San Gerardo dei Tintori -Ematologia

Monza, Italy

I.R.C.C.S. Istituto Oncologico Veneto -Oncologia 1

Padova, Italy

Policlinico Giaccone - Ematologia

Palermo, Italy

Azienda Sanitaria Locale di Pescara- Presidio Ospedaliero Santo Spirito - U.O.C. Ematologia

Pescara, Italy

Azienda USL Piacenza - UOC Ematologia e Centro Trapianti,

Piacenza, Italy

Ospedale delle Croci - Ematologia

Ravenna, Italy

Azienda Unità Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova - Ematologia

Reggio Emilia, Italy

Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapie Cellulari, Policlinico Universitario Campus Bio-Medico

Roma, Italy

AOU Senese - U.O.C. Ematologia

Siena, Italy

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

Torino, Italy

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

Torino, Italy

Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI) - S.C. Ematologia

Trieste, Italy

AOU Integrata di Verona - U.O. Ematologia

Verona, Italy

View Full Details on ClinicalTrials.gov

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NCT06835530