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
Study ID
NCT06835530
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Non-Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
80 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rituximab + Golcadomide (CC-99282) — DRUG
    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).

Study Details

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.

Key Dates

Start date
Apr 9, 2025
Status verified
Dec 2025
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
47 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab in combination with Golcadomide (CC-99282)
    Induction Phase (6 cycles every 28 days): Cycle 1 (Rituximab 375 mg/mq i.v. on days 1, 8, 15; Golcadomide 0,3 mg/day p.o. days 1-14; Dexamethasone 5 mg p.o. on days 1, 8, 15, 22). Cycles 2-6 (Rituximab 375 mg/mq i.v. on day 1; Golcadomide 0,4 mg/day p.o. days 1-14). Consolidation phase (for patients achieving at least a partial response at the end of induction (≥PR), the consolidation phase will start within 6-8 weeks from Cycle 6 Day1 and will be continued up to 6 cycles every 28 days): golcadomide 0.2 mg / day p.o. days 1-14. Consolidation radiotherapy: involved site radiotherapy (ISR) is allowed at the end of induction phase on PET positive sites, according to the available guidelines (Illidge et al., 2014). ISR should be concomitant to consolidation phase.

Primary Outcome Measure

Progression free survival (PFS) at 24 months [ Time Frame: from enrollment to 24 month ]

Central Contacts