NCT06835530

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective, multicenter, phase II study, in older patients affected by DLBCL defined as frail according to sGA and previously untreated. All patients will receive an induction phase with a combination of golcadomide, rituximab and only at cycle 1 dexamethasone, for a maximum number of 6 cycles of 28 days. Response assessment is planned after 4 and after 6 cycles for identification of non-responding patients. Patients achieving at least a PR at the interim restaging and after 6th cycle will complete therapy as planned, while patients with stable and progressive disease will discontinue protocol treatment and will be addressed to an alternative regimen. At the end of the 6th cycle of induction (EOI), involved site radiotherapy is allowed on PET positive sites. At EOI (end of induction), if the patient reached at least a partial response (≥PR), a consolidation phase was planned with golcadomide, for a maximum of 6 cycles of 28 days. During consolidation phase, an interim check for response will be performed after the completion of 3 cycles in order to early identify progressive disease. Patients with progressive disease will stop protocol treatment and will be treated at physician discretion. End of treatment response will be evaluated within 4-6 weeks after the last cycle of consolidation (or the last study medication administration). All patients will be monitored during follow up for 24 months, every 3 months for the first year and every 6 months for the second year. Patients experimenting progression at any time will be considered as treatment failures and will be followed-up for survival until the end of the study. Baseline and EOT 18FDG PET/CT or CT scan including pre-contrast phase (only if PET/CT is not performed) will be evaluated for sarcopenia assessment. Quality of life (QoL) evaluation is planned at study entry and at established timepoints during and after treatment and follow-up.

Conditions

• Diffuse Large B Cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab + 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).

Timeline

• Start date: 2025-04-09
• Primary completion: 2030-04-01
• Completion: 2030-04-01
• First posted: 2025-02-19
• Last updated: 2026-01-02

Locations

20 sites across 1 country: Italy