LETERMOVIR for Cytomegalovirus infection (post-allogeneic stem cell transplantation)

Inclusion criteria

• {"criterion_text":"- Age ≥18 years\n- First allogenic HCT.\n- Pre-HCT patient CMV negative IgG serology with CMV IgG positive donor serostatus.\n- Able to provide written consent and complete the informed consent.\n- Absence of CMV DNAemia requiring antiviral therapy within 5 days before initiation of LMV."}

Exclusion criteria

• {"criterion_text":"- Active pre-emptive therapy for csCMV-I.\n- History of current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or would place the subject at undue risk as judged by the investigator, such that it is not in the best interest of the subject to participate in this study.\n- Patients who have received LMV prophylaxis prior to enrollment.\n- Glomerular filtration rate (GFR) </=30 mL/min/1.73m^2 (equivalent to creatinine clearance (ClCr) </=10 mL/min).\n- Severe hepatic function grade 3-4 CTAE at the time of study entry.\n- Suspected or known hypersensitivity to active or inactive ingredients of LMV formulations.\n- History of allergic reactions attributed to compounds of similar chemical or biologic composition to LMV\n- Patients with previous untreated reactivation.\n- Pregnancy or breastfeeding.\n- Plans to conceive or father children within the projected duration of the trial."}

Primary endpoints

• {"endpoint_text":"- csCMV infection is considered in case the patient requires pharmacological treatment according to standard clinical practice.","definition_or_measurement_approach":"csCMV infection defined as cases where the patient requires pharmacological treatment according to standard clinical practice."}

Secondary endpoints

• {"endpoint_text":"- csCMV infection is considered in case the patient requires pharmacological treatment according to standard clinical practice.","definition_or_measurement_approach":"csCMV infection defined as cases where the patient requires pharmacological treatment according to standard clinical practice."}
• {"endpoint_text":"- Clinical characteristic","definition_or_measurement_approach":"Descriptive assessment of clinical characteristics."}
• {"endpoint_text":"- Neutrophile (>0,5x10e9/L) and platelets engraftment (>20 x10e9/L) by week 4 and week 14","definition_or_measurement_approach":"Engraftment defined by neutrophils >0.5 x10^9/L and platelets >20 x10^9/L assessed at week 4 and week 14."}
• {"endpoint_text":"- Death by any cause and death not related with disease relapse or progression","definition_or_measurement_approach":"All-cause mortality and non-relapse mortality assessed at specified timepoints."}
• {"endpoint_text":"- Death by any cause non related to relapse by week 14 and day 180","definition_or_measurement_approach":"All-cause non-relapse death assessed at week 14 and day 180 post-HCT."}
• {"endpoint_text":"- Time to onset of all-cause failure of prophylaxis against CMV infection during the 14 weeks of study-drug administration period including patients who discontinued the study drug because of virologic failure or for any other reason (e.g., an adverse event, nonadherence, or consent withdrawal).","definition_or_measurement_approach":"Time-to-event analysis measuring time from start of prophylaxis to prophylaxis failure (including discontinuations for virologic failure, AE, nonadherence, or consent withdrawal) during 14-week administration period."}
• {"endpoint_text":"- Duration of any CMV-antiviral treatment by day 180 post-SCT","definition_or_measurement_approach":"Total duration (days) of CMV-directed antiviral therapy up to day 180 post-SCT."}
• {"endpoint_text":"- Direct cost of CMV-antiviral treatment and hospital resource","definition_or_measurement_approach":"Health economic assessment of direct antiviral treatment costs and hospital resource utilization by day 180 post-SCT."}
• {"endpoint_text":"- Incidence of blips, clinical and analytic characteristics.","definition_or_measurement_approach":"Incidence and description of transient low-level CMV DNAemia ('blips') with associated clinical and laboratory features."}
• {"endpoint_text":"- Incidence of untreated CMV DNAemia","definition_or_measurement_approach":"Incidence of CMV DNAemia episodes not requiring pre-emptive therapy."}
• {"endpoint_text":"- Adverse events according to the CTCAE, physical examination and regular laboratory tests. Only adverse events (AE) related to the treatment according to investigator","definition_or_measurement_approach":"Safety assessment of AEs related to treatment per CTCAE, physical exams and labs as judged by investigator."}
• {"endpoint_text":"- Incidence of aGVHD within 120 days after HCT and its onset and severity","definition_or_measurement_approach":"Incidence, onset and severity grading of acute GVHD within 120 days post-HCT."}
• {"endpoint_text":"- Incidence of relapse within 180 days after HCT and its onset and severity","definition_or_measurement_approach":"Incidence, onset and severity of disease relapse within 180 days post-HCT."}
• {"endpoint_text":"- Incidence of CMV DNAemia requiring PET within 100-180 days after HCT","definition_or_measurement_approach":"Incidence of CMV DNAemia episodes requiring pre-emptive therapy (PET) between day 100 and day 180 post-HCT."}
• {"endpoint_text":"- Incidence of non-CMV infections within 180 days after HCT and its onset and severity","definition_or_measurement_approach":"Incidence, onset and severity of non-CMV infections within 180 days post-HCT."}

Spain

Earliest CTIS Part Ii Submission Date

04-08-2024

Latest Decision Or Authorization Date

12-12-2024

Processing Time Days

130

Number Of Sites

12

Number Of Participants

80

Primary sponsor

Full Name

Grupo Español de Trasplantes Hematopoyéticos y Terapia Celular

Organisation Type

Health care

Country Of Registered Address

Spain