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The primary endpoint for the RIALTO trial is the frequency of Grade 2-5 hematological toxicity (worst per patient) from initiation of treatment with RLT up to 24 months thereafter according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5)
Best hormonal response defined as greatest decrease, or >30% decrease, of chromogranin A and 5HIAA from baseline if baseline levels were >2x ULN or 5xULN
Best radiological response according to local investigator RECIST V1.1
Duration of response (DoR) according to local investigator RECIST v1.1. Time from first response (CR or PR), according to ORR definition for the trial, to the date of the documented PD as determined using RECIST v1.1 criteria or death due to any cause, whichever occurs first. Those patients with response and without PD or death event will be censored on the date of their last tumor assessment.
Objective response rate (ORR) according to local investigator RECIST v1.1. Assessed by the investigator through imaging follow-up (CT scan/MRI) using RECIST v1.1 (Appendix 3). This will be considered as the percentage/proportion of randomized patients with complete response (CR) or partial response (PR) as their overall best response throughout the study period. The investigator will report the change in size of tumors as compared with baseline, before the first dose of study treatment.
Disease control rate (DCR) RECIST v1.1 according to local investigator RECIST v1.1. Assessed by the investigator through imaging follow-up (CT scan/MRI) using RECIST v1.1. This will be considered as the percentage/proportion of randomized patients with complete response (CR) or partial response (PR) as their overall best response throughout the study period. The investigator will report the change in size of tumors as compared with baseline, before the first dose of study treatment.
Progression-free survival (PFS) (investigator assessed) defined as the time between randomization date and disease progression according to RECIST v1.1 or death from any cause (primary analysis of PFS) .PFS will be censored at the date of the last adequate tumor assessment if no PFS event is observed prior to the analysis cut-off date.
Progression-free survival (PFS) (investigator assessed) defined as the time between randomization date and disease progression according to RECIST v1.1 or death from any cause (primary analysis of PFS). PFS will be censored at the date of the last adequate tumor assessment if no PFS event is observed prior to the analysis cut-off date.
Progression-free survival (PFS) (investigator assessed) defined as the time between randomization date and disease progression according to RECIST v1.1 or death from any cause (primary analysis of PFS) .PFS will be censored at the date of the last adequate tumor assessment if no PFS event is observed prior to the analysis cut-off date.
Overall survival defined as the time elapsed from randomization until death from any cause. Patients alive and free of events at the date of the analysis will be censored at their last known contact.
Overall survival defined as the time elapsed from randomization until death from any cause. Patients alive and free of events at the date of the analysis will be censored at their last known contact.
Overall survival defined as the time elapsed from randomization until death from any cause. Patients alive and free of events at the date of the analysis will be censored at their last known contact.
Overall survival defined as the time elapsed from randomization until death from any cause. Patients alive and free of events at the date of the analysis will be censored at their last known contact.
Percentage of patients with Non-hematological toxicity. Non-hematological toxicity: defined as worst grade non-hematological toxicity per patient according to NCI-CTCAE v 5.0 criteria.
Rate of clonal hematopoiesis by Next-Generation Sequencing (NGS) of ctDNA calculated by mutations frequency in ctDNA samples
Rate of clonal hematopoiesis by Next-Generation Sequencing (NGS) of ctDNA calculated by mutations frequency in ctDNA
Rate of clonal hematopoiesis by Next-Generation Sequencing (NGS) of ctDNA calculated by mutations frequency in ctDNA samples
Rate of clonal hematopoiesis by Next-Generation Sequencing (NGS) of ctDNA calculated by mutations frequency in ctDNA samples.
Number of RLT cycles per patient
Number acumulative dose received each patient
Treatment compliance analyzing treatment delays and interruptions due to toxicity, rate of patients completing planned schedule, time from first to last RLT dose
Rate of Grade 2-5 hematological toxicity (worst per patient) from initiation of treatment with RLT up to 12 months after the last PRRT
PFS will also be centrally assessed according to RECIST 1.1 based only on morphological imaging (CT/MRI scans), regardless of SRI-PET scan results.
Progression-free survival will also be centrally assessed according to RECIST 1.1 based on both morphological (CT/MRI scans) and functional imaging.
PFS will also be assessed according to RECIST 1.1 based only on morphological imaging (CT/MRI scans), functional imaging and clinically progression of the functional syndrome, defined as unequivocal worsening of the functioning syndrome at the investigator criteria
Number patients that suffered a Adverse event (AE) or serious adverse events (SAE) specific
Number Treatment-related AEs (TRAEs).
Patients reported outcomes through the EORTC QLQ-C30 and GINET21 questionnaires.
Porcentatge patients with myeloid neoplasms
Incidence of severe infection/sepsis (antibiotics prescription, hospitalization)
Rate of adverse events ≥ Grade 2 under subsequent next line of systemic treatment
Duration of adverse events ≥ Grade 2 (median, %>6 months)