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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
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).
AOU SS. Antonio e Biagio e Cesare Arrigo di Alessandria - SCDU Ematologia
Alessandria, Italy
RECRUITINGAOU Ospedali Riuniti - Clinica di Ematologia
Ancona, Italy
RECRUITINGAzienda Ospedaliera S. Giuseppe Moscati - S.C. Ematologia e trapianto emopoietico
Avellino, Italy
RECRUITINGOspedale IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuno-correlati
Aviano, Italy
RECRUITINGASST Spedali Civili di Brescia - Ematologia
Brescia, Italy
RECRUITINGAzienda Ospedaliera Universitaria Careggi -Unità Funzionale di Ematologia
Florence, Italy
RECRUITINGASST Grande Ospedale Metropolitano Niguarda - SC Ematologia
Milan, Italy
RECRUITINGFondazione IRCCS San Gerardo dei Tintori -Ematologia
Monza, Italy
RECRUITINGI.R.C.C.S. Istituto Oncologico Veneto -Oncologia 1
Padua, Italy
RECRUITINGPoliclinico Giaccone - Ematologia
Palermo, Italy
NOT_YET_RECRUITING...and 10 more locations
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.
Time frame: from enrollment to 24 month
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
Time frame: From the start of treatment to approximately 4 months and 6 months
Overall survival (OS)
OS defined as the time between the start of prephase and death from any cause
Time frame: from enrollment to 60 month
Rate of treatment discontinuation due to AE or treatment intolerance
Rate of treatment discontinuation due to AE or treatment intolerance
Time frame: From the start of treatment to 60 months
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
Time frame: The endpoint wil be evaluated at the baseline
QoL (quality of life) scores variations at 6 months - 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
Time frame: The endpoint will be evaluated from the beginning of the study to 6 months
QoL (quality of life) scores variations at 12 months - 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
Time frame: The endpoint will be evaluated from the beginning of the study to 12 months
QoL (quality of life) scores at baseline - FACT-Lym-LymS
Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms)
Time frame: The endpoint wil be evaluated at the baseline
QoL (quality of life) scores variations at 6 months - FACT-Lym-LymS
Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms questionnaire)
Time frame: The endpoint will be evaluated from the beginning of the study to 6 months
QoL (quality of life) scores variations after 12 months - FACT-Lym-LymS
Quality of life is measured with the FACT-Lym-LymS (Functional Assessment of Cancer Therapy - Lymphoma- lymphoma-specific symptoms)
Time frame: The endpoint will be evaluated from the beginning of the study to 12 months
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