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.
Able to provide written informed consent form approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study- specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.
Histologically documented diagnosis of DLBCL as defined in the 5th edition of the World Health Organization (WHO) classification (2022)
Previously untreated
Frail patients defined as follows (Appendix A-D): Age ≥ 80 years: activity of daily living (ADL) < 6 residual functions and/or Instrumental activity of daily living (IADL) < 8 residual functions and/or cumulative illness rating scale (CIRS) > 5 comorbidities of grade 2 and/or one or more comorbidities of grade 3-4
Histological diagnosis different from DLBCL
Central nervous system (CNS) involvement with lymphoma
Severe heart failure (NYHA grado III-IV and/or LVEF < 45%), liver disease Child Pugh C, history of interstitial lung disease, non-infectious pneumonitis, pulmonary fibrosis, or pulse oximetry of < 92% while breathing room air, or any other clinical condition that would preclude participation in the study or compromise ability to give informed consent
Any history of other active malignancies within 5 years prior to study entry, except for adequately treated in situ carcinoma of the cervix uterine, basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin, previous malignancy confined and surgically resected with curative intent
Single group
Rituximab + Golcadomide (CC-99282)
DrugA 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).
Progression free survival (PFS) at 24 months
PFS defined as the time between the start of prephase and the first documentation of recurrence, progression or death from any cause.
ORR Overall response rate (partial response, PR + complete response, CR) and CR after the 4th and 6th cycle
ORR Overall response rate (partial response, PR + complete response, CR) and CR after the 4th and 6th cycle
Overall survival (OS)
OS defined as the time between the start of prephase and death from any cause
Rate of treatment discontinuation due to AE or treatment intolerance
Rate of treatment discontinuation due to AE or treatment intolerance
QoL (quality of life) scores at baseline - EORTC-QLQ-C30
Quality of life is measured with the EORTC-QLQ-C30 (European Organisation for Research and Treatment of Cancer-Quality of life Questionnaire-Core 30) questionnaire
Difference of sarcopenia degree before and after treatment according to European Working Group on Sarcopenia in Older People (EWGSOP2)
To assess sarcopenia at study entry and after treatment
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