An interventional study of Determination of HCMV DNA in plasma after DNAse digestion. and Determination of HCMV DNA in blood or plasma. in Cytomegalovirus Infections, Cytomegalovirus Viremia and Hematopoietic Stem Cell Transplantation, sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia. Recruiting at 8 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-06.
Sponsored by Fondazione IRCCS Policlinico San Matteo di Pavia · Not applicable, Interventional, and Diagnostic
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Among 18 studies in Cytomegalovirus Infections with a site in Italy — 5 open to participants now, 6 under way, 1 of them phase 3. Cytomegalovirus Infections · Italy.
Among the 18 studies in Cytomegalovirus Infections with a site in Italy, this one is the 12th largest by planned enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2023, is one of 3 with no phase, and was the 16th registered.
370 studies on the registry are indexed under Cytomegalovirus Infections; 57 are open to participants now.
Browse Cytomegalovirus Infections studies →5 of the 18 studies in Cytomegalovirus Infections with a site in Italy are open now. Recruiting first, the newest first:
Antonello Di Paolo, M.D., Ph.D. · Sites in Italy
Ages 1 mo–18 yrs
MSD Italia S.r.l. · Sites in Italy
Ages 0–18
IRCCS Azienda Ospedaliero-Universitaria di Bologna · Sites in Italy, United States, Belgium and 6 more countries
Ages 18+
Tobias Feuchtinger · Sites in Italy, Belgium, France and 3 more countries
Ages 2 mo+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 35 Cytomegalovirus Infections studies recruiting now, 20 (57%) set no upper age limit and 13 (37%) stop at 75 or younger; 19 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 10 · Phase 4 1
First in 2004; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 140 is above the median of 64 across 240 interventional studies indexed under Cytomegalovirus Infections.
Median enrollment 326 across the 14 interventional studies, 177 across the 4 observational. Of the 9 that completed or were terminated, 4 (44%) have results posted.
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7 of 18 have an industry lead sponsor. The 10 most frequent:
Fondazione IRCCS Policlinico San Matteo di Pavia is the lead sponsor of 258 studies on the registry; 115 are open to participants now.
Fondazione IRCCS Policlinico San Matteo di Pavia has 4 studies filed under Cytomegalovirus Infections — fewer than ten, so there is no comparison to draw.
1 of the studies in Cytomegalovirus Infections with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05234723IRCCS Azienda Ospedaliero-Universitaria di BolognaGanciclovir Resistant/Refractory Cytomegalovirus Infection in SOT Recipients and HSCT Patients | 2027-02-28 |
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Among the 18 studies in Cytomegalovirus Infections with a site in Italy, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The goal of this clinical trial is to compare two strategies to monitor human cytomegalovirus (HCMV) infections in transplanted patients receiving letermovir (LTV) as anti-HCMV prophylaxis.
HCMV infection after transplantation is diagnosed by detection of HCMV DNA in blood. However, due to the peculiar mechanism of action of LTV, most episodes of HCMV DNA detection are caused by release in the blood stream of non-infectious HCMV DNA.
In true episodes of productive infection, HCMV DNA in blood is present inside the virion and therefore is resistant to DNAse digestion. Conversely, when non-infectious free-floating HCMV DNA is released in the bloodstream, it will be degraded after treatment of plasma with DNAse and will not be detectable by real-time PCR assays.
Researchers will compare determination of HCMV DNA in blood with or without previous digestion of non-infectious free-floating DNA with DNAse.
In patients of the Control group HCMV DNA will be tested without DNAse digestion. If HCMV DNA is positive, patients will stop LTV prophylaxis and receive antiviral therapy with another drug.
In patients of the Study group HCMV DNA will be tested after DNAse digestion. Only if HCMV DNA is positive after DNAse digestion, patients will stop LTV prophylaxis and receive antiviral therapy with another drug.
The main aim of the study is to demonstrate that, by avoiding inappropriate antiviral therapy during LTV prophylaxis, transplant patients will suffer of lower antiviral-drug-related toxicity. A monitoring strategy able to identify true episodes of HCMV productive infection during LTV prophylaxis will lead to a lower rate of inappropriate antiviral therapy and drug-related toxicity without an increased risk of HCMV disease.
Patients will be enrolled at the start of conditioning regimen, and all patients of both arms will receive LTV prophylaxis after transplantation until day 100, according to standard procedures. Patients will be randomized (1:1) in two arms in case of positive HCMV DNAemia and will follow two different diagnostic strategies to assess HCMV refractivity to LTV prophylaxis.
GCV/VGCV/FOS pre-emptive therapy will be stopped in all cases after detection of a negative HCMV DNAemia (i.e. below detection level of the assay adopted) in two consecutive samples.
After the end of LTV prophylaxis, HCMV infection will be treated with pre-emptive therapy according to current procedures of each center.
The hypothesis is that in the Study arm, due to the lower use of antiviral drugs as preemptive therapy, a significant reduction of neutropenia, renal failure and/or alteration in plasma electrolytes will be observed without an increase of HCMV diseases.
Study definitions
Antiviral drug-related toxicity will be considered as neutrophil impairment or kidney injury occurring at least 5 days after start of preemptive antiviral therapy.
Sample collection
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will stop LTV shifting to GCV/VGCV/FOS pre-emptive therapy in case of positive HCMV DNA and subsequent confirmation of productive infection by detection of DNAse-resistant HCMV plasma DNAemia. However, for safety reasons, patients of the Study arm will stop LTV and shift to pre-emptive therapy in case of HCMV DNAemia \>10,000 copies/ml whole blood in two consecutive samples, even if DNAse-resistant HCMV plasma DNAemia is negative.
Diagnostic Test: Determination of HCMV DNA in plasma after DNAse digestion.
Patients will stop LTV shifting to GCV/VGCV/FOS pre-emptive therapy in case of positive HCMV DNAemia confirmed in two consecutive samples.
Diagnostic Test: Determination of HCMV DNA in blood or plasma.
Plasma will be tested after DNAse digestion for quantification of virion-associated HCMV DNA (defined as true breakthrough HCMV productive infection).
HCMV DNA will be determined in blood or plasma without DNAse digestion, as per current clinical practice.
- Proportion of patients with positive HCMV DNAemia developing antiviral drug-related toxicity.
Antiviral drug-related toxicity will be considered as neutrophil impairment or kidney injury. Patients who exit before day 100 for death, underlying disease relapse, or transplant rejection after detection of HCMV-positive DNAemia will be considered as failures and counted along with antiviral drug-related toxicities for the analysis of the primary end-point occurring at least 5 days after start of preemptive antiviral therapy
Time frame: Day 100
Proportion of patients developing HCMV DNAemia during LTV prophylaxis.
Time frame: Day 100
Proportion of patients developing HCMV disease within day 100 and between day 100 and 360 from transplant (key secondary endpoint)
Time frame: Day 100 and day 360
Proportion of patients stopping LTV prophylaxis and shifting to GCV/VGCV/FOS therapy.
Time frame: Day 100
Proportion of patients requiring GCV/VGCV/FOS therapy between day 100 and 360.
Time frame: Day 360
Proportion of patients with persisting HCMV DNAemia.
Positive DNAemia persisting two weeks after the first positive HCMV DNAemia.
Time frame: Day 360
Proportion of patients developing neutropenia between day 100 and 360.
Time frame: Day 360
Proportion of patients developing HCMV-specific T-cell response at day 100, 180, and 360.
Time frame: Day 100, day 180 and day 360
Proportion of patients developing LTV-resistant HCMV strains.
Time frame: Day 100
Cumulative incidence of acute or chronic GvHD.
Time frame: Day 100 and day 360
Transplant related mortality (TRM), underlying disease relapse, and 1-year survival.
Time frame: Day 360
Plan to share: No
Started Jan 2023 (actual). Primary completion is estimated for Jun 2025, 29 months after the start.
Of 23 interventional studies with no phase under Cytomegalovirus Infections, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 56. This study's planned 29 months is below that.
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Fondazione IRCCS Policlinico San Matteo di Pavia →