Cytomegalovirus InfectionsPhase 2CMV-GVHDNCT05370976
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.
A Phase 2 study testing Cytotect®CP in people with Cytomegalovirus Infections, run by University Hospital, Lille at 1 site in France.
Trial 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 antithymocyte globulin (ATG), and development of GVHD. Acute GVHD occurs during the first hundred days after transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- What is being tested?
- Cytotect®CP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 13 Sep 2022to 24 Aug 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- - 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)
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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: A Prospective, Open-label, Phase II Study
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 antithymocyte globulin (ATG), and development of GVHD. Acute GVHD occurs during the first hundred days after transplantation. In spite of systematic GVHD prophylactic using immunosuppressive agents, approximately 50% of transplantation recipients develop GVHD. The first-line treatment of acute GVHD is methylprednisolone 2 mg/kg/day. Probably because of the use corticosteroids but also due to the GVHD itself, approximately 46% of CMV seropositive patients develop CMV infection (report from the national database of the SFGM-TC, data unpublished yet).
CMV infection leads to longer duration of hospitalization and increases the risk of mortality, particularly in cases of CMV disease. Available antiviral agents used to prevent CMV infections are generally reputed to cause significant side effects. These agents can prevent full immunological post-transplant reconstitution and cause profound cytopenia. Some agents may be responsible for renal impairment, which prevents continuation of immunosuppressive treatment; this is especially the case with calcineurin inhibitors in allo-HCT patients. Indeed, compared to placebo, intravenous ganciclovir has been shown to reduce the risk of CMV infection and disease, although it did not appear to improve overall survival. However, it was responsible for 30% of cases of severe neutropenia in allo-HCT patients, increasing the risk of bacterial and fungal coinfections. CMV infection treatment is commonly based on ganciclovir and foscavir and, to a lesser extent, on other drugs, including cidofovir. However, these drugs cause high levels of toxicity, resulting in myelotoxicity in the case of ganciclovir, or, in the case of foscavir and cidofovir, potential renal failure, incurring treatment discontinuation.
Read more
CMV prophylaxis using drugs with fewer side-effects is necessary in patients at high risk of CMV infection.
With its safety profile, Cytotect®CP offers an alternative option for CMV prophylaxis with avoidance of renal and bone marrow impairment.
Considering the high risk of developing CMV infection, we decided to investigate the efficacy and safety of Cytotect®CP in patients requiring systematic corticosteroids (≥ 1 mg/kg/day) for an initial episode of grade II-IV acute GVHD following a first allo-HCT.
- Conditions
- Cytomegalovirus Infections
- Being tested
- Cytotect®CP
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytotect®CPDrug
Cytotect®CP in two phases:
Induction phase: 1 ml/kg/week for 4 weeks Maintenance phase: 1 ml/kg/2 weeks for 12 weeks or corticosteroid dose < 0.5 mg/kg, according to which condition occurs first.
Patients developing CMV infection under Cytotect®CP must be given standard anti-CMV treatment (Gancyclovir or Foscarnet) according to their center procedure. Cytotect®CP will be maintained
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: Cytotect®CP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CMV infection within 16 weeks of Cytotect®CP therapy.
Measured: within 16 weeks
Secondary outcomes (6)
Time from inclusion to death from any cause or death without relapse of the underlying disease within 6 months
Measured: from inclusion to 16 weeks
Time from inclusion to EBV, adenovirus or BK virus co-infection ≤ 16 weeks.
Measured: within the 16 weeks from inclusion
Time from inclusion to CMV infection ≤ 16 weeks.
Measured: within the 16 weeks from inclusion
Time from inclusion to CMV disease ≤ 16 weeks
Measured: within the 16 weeks from inclusion
Frequency of adverse events (grades 3 and 4)
Measured: from 1st administration of Cytotect®CP throughout the 4 weeks after the last administration of Cytotect®CP, an average 20 weeks
Analysis of immune reconstitution under Cytotect®CP.
Measured: Througth study completion, an average 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start13 Sep 2022
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Why it stopped: Inclusion difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Biotest
- Responsible party
- Sponsor
- Investigators
- Ibrahim Yakoub-Agha, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370976
- Sponsor's protocol ID
- 2020_42
- Other IDs
- 2020-004698-30
- Acronym
- CMV-GVHD
- Status last verified
- Sep 2025
- First submitted
- 19 May 2021
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: A Prospective, Open-label, Phase II Study
- ClinicalTrials.gov ID
- NCT05370976
- Acronym / sponsor ID
- CMV-GVHD / 2020_42
- Conditions
- Cytomegalovirus Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion difficulties
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Biotest
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 antithymocyte globulin (ATG), and development of GVHD. Acute GVHD occurs during the first hundred days after transplantation. In spite of systematic GVHD prophylactic using immunosuppressive agents, approximately 50% of transplantation recipients develop GVHD. The first-line treatment of acute GVHD is methylprednisolone 2 mg/kg/day. Probably because of the use corticosteroids but also due to the GVHD itself, approximately 46% of CMV seropositive patients develop CMV infection (report from the national database of the SFGM-TC, data unpublished yet).
CMV infection leads to longer duration of hospitalization and increases the risk of mortality, particularly in cases of CMV disease. Available antiviral agents used to prevent CMV infections are generally reputed to cause significant side effects. These agents can prevent full immunological post-transplant reconstitution and cause profound cytopenia. Some agents may be responsible for renal impairment, which prevents continuation of immunosuppressive treatment; this is especially the case with calcineurin inhibitors in allo-HCT patients. Indeed, compared to placebo, intravenous ganciclovir has been shown to reduce the risk of CMV infection and disease, although it did not appear to improve overall survival. However, it was responsible for 30% of cases of severe neutropenia in allo-HCT patients, increasing the risk of bacterial and fungal coinfections. CMV infection treatment is commonly based on ganciclovir and foscavir and, to a lesser extent, on other drugs, including cidofovir. However, these drugs cause high levels of toxicity, resulting in myelotoxicity in the case of ganciclovir, or, in the case of foscavir and cidofovir, potential renal failure, incurring treatment discontinuation.
CMV prophylaxis using drugs with fewer side-effects is necessary in patients at high risk of CMV infection.
With its safety profile, Cytotect®CP offers an alternative option for CMV prophylaxis with avoidance of renal and bone marrow impairment.
Considering the high risk of developing CMV infection, we decided to investigate the efficacy and safety of Cytotect®CP in patients requiring systematic corticosteroids (≥ 1 mg/kg/day) for an initial episode of grade II-IV acute GVHD following a first allo-HCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Cytotect®CP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (13 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytotect®CPCytotect®CP in two phases: Induction phase: 1 ml/kg/week for 4 weeks Maintenance phase: 1 ml/kg/2 weeks for 12 weeks or corticosteroid dose < 0.5 mg/kg, according to which condition occurs first. Patients developing CMV infection under Cytotect®CP must be given standard anti-CMV treatment (Gancyclovir or Foscarnet) according to their center procedure. Cytotect®CP will be maintained | Drug | Experimental group |
Primary outcome
Rate of CMV infection within 16 weeks of Cytotect®CP therapy.
Time frame: within 16 weeks
6 secondary outcomes
Time from inclusion to death from any cause or death without relapse of the underlying disease within 6 months
Time frame: from inclusion to 16 weeks
Time from inclusion to EBV, adenovirus or BK virus co-infection ≤ 16 weeks.
Time frame: within the 16 weeks from inclusion
Time from inclusion to CMV infection ≤ 16 weeks.
Time frame: within the 16 weeks from inclusion
Time from inclusion to CMV disease ≤ 16 weeks
Time frame: within the 16 weeks from inclusion
Frequency of adverse events (grades 3 and 4)
Time frame: from 1st administration of Cytotect®CP throughout the 4 weeks after the last administration of Cytotect®CP, an average 20 weeks
Analysis of immune reconstitution under Cytotect®CP.
Time frame: Througth study completion, an average 24 months
Results and safety
The study was stopped early (reason given: Inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ibrahim Yakoub-Agha, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cytotect®CP in people with Cytomegalovirus Infections, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inclusion difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of CMV infection within 16 weeks of Cytotect®CP therapy. (time frame: within 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.