Post-transplant human cytomegalovirus (CMV) infection is a challenge in patients receiving allogeneic hematopoietic cell transplants (allo-HCT) due to severe immunosuppression. In the absence of treatment, CMV infection can progress to CMV end-organ disease, CMV infection also has potential consequences on the immune system such as graft-versus-host disease (GvHD) and bacterial, viral or fungal infections. And remains an important cause of morbidity and mortality in allo-HCT patients
Conditions
Interventions
Product Name: Cytotect®CP Biotest 100 U/ml (vial50 ml et 10 ml)
Pharmaceutical Form: Solution for infusion
Sponsors
CHU de Lille
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients aged = 18 years and able to provide informed consent - Patients before day +100 of first allo-HCT - Any indication, any stem cell source, any conditioning, any donor type or HLA-matching - Patients with positive CMV-serostatus before transplant - Patients with first episode of grade II-IV acute GVHD requiring systemic corticosteroids ? 1 mg/kg/day - Absence of CMV infection at the time of inclusion - Absence of other viral infections (EBV, adenovirus, BK virus) at the time of inclusion - Absence of dialysis - Absence of thrombotic microangiopathy - Absence of macrophage activation syndrome Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients receiving corticosteroids > 0.5 mg/kg/day for more than 5 days before inclusion - Uncontrolled CMV infection within 30 days before inclusion - Inability to understand the investigational nature of the study or to give informed consent - ECOG Performance Status = 3 - Evidence of relapse of underlying disease - Patients receiving or having received anti-CMV treatment within 30 days before inclusion (acyclovir and valacyclovir are not considered as CMV prophylaxis) - Hypersensitivity to Cytotect®CP or to any of the excipients - Hypersensitivity to human immunoglobulins, especially in patients with antibodies against IgA - Patients with any contra-indication to Cytotect®CP - Females either pregnant/breast-feeding or planning to become pregnant - Patients developing post-DLI grade II-IV acute GVHD - Freedom privacy - Absence of medical insurance cover
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate Cytotect®CP efficacy in decreasing the rate of CMV infection within 16 weeks in patients developing acute grade II-IV GVHD after allo-HCT.;Secondary Objective: -Evaluation of OS and NRM at 6 months -16-week CI of EBV, adenovirus and BK virus co-infections -16-week CI of CMV disease -16-week CI of CMV infection -Evaluation of adverse events -Improvement of immune reconstitution after Cytotect®CP;Primary end point(s): Rate of CMV infection within 16 weeks of Cytotect®CP therapy;Timepoint(s) of evaluation of this end point: As specified in the primary end point: Rate of CMV infection within 16 weeks of Cytotect®CP therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Time from inclusion to death from any cause or death without relapse of the underlying disease within 6 months - Time from inclusion to EBV, adenovirus or BK virus co-infection = 16 weeks. - Time from inclusion to CMV infection = 16 weeks. - Time from inclusion to CMV disease = 16 weeks - Frequency of adverse events (grades 3 and 4) to be collected from 1st administration of Cytotect®CP to 1 month after the last administration of Cytotect®CP - Analysis of immune reconstitution under Cytotect®CP. ;Timepoint(s) of evaluation of this end point: As spicified for each end point. | — |
Countries
France, Saudi Arabia, Switzerland
Contacts
Public ContactKarim DAHACHE (CRA)
clinical research direction
Outcome results
None listed