Status:
TERMINATED
Efficacy and Safety of Cytotect®CP, Hyperimmune Anti-CMV IVIg as CMV Prophylaxis in Patients Developing Acute Grade II-IV GVHD After Allogeneic Hematopoietic Cell Transplantation.
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Biotest
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Many risk factors are known to be associated with high risk of developing CMV infection in positive CMV-serostatus patients: negative CMV-serostatus donor, unrelated or mismatched donor, use of antith...
Eligibility Criteria
Inclusion
- Able to provide informed consent
- Patients before day from 29 days to 150 days 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
Exclusion
- \- Patients receiving corticosteroids \> 0.5 mg/kg/day for more than 5 days before inclusion
- Uncontrolled CMV infection within 02 weeks 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
Key Trial Info
Start Date :
September 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2023
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT05370976
Start Date
September 13 2022
End Date
August 24 2023
Last Update
September 30 2025
Active Locations (1)
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1
Hop Claude Huriez Chu Lille
Lille, France