CMV InfectionCY-CMV-2020NCT05315882
Cytomegalovirus Infection After HSCT and PT-CY as GVHD Prophylaxis >> GVHD PROPHYLAXIS ERA
An observational study of CMV Infection, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
Trial summary
Multicentre, observational, retrospective study to analyze the differences in CMVi pattern and recurrences between two groups of allogeneic HSCT patients (haplo vs no haplo HSCT), with intervention both postransplant cyclophosphamide as GvHD prophylaxis, using a database with information from historical clinic data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CMV Infection
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 14 Feb 2020to 17 Dec 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: 300 patients with hematological malignancies under HSCT from matched sibling donors, unrelated matched and mistmatched donor and haploidentical family donor using PT-CY and CNI as GVHD prophylaxis
Who may be able to join
- Age > 18 years.
- Period of HSCT: January 1st 2013 to December 31th 2018.
- GvHD prophylaxis: Post-transplantation Cyclophosphamide (50 mg/Kg on days +3 and +4 or +3 and +5) and calcineurine inhibitors as GvHD prophylaxis.
- Conditioning chemotherapy regimen and source of stem cells: myeloablative or reduced intensity TBF (Thiotepa 5 mg/Kg D -7-6, Fludarabine 50 mg/m2 D -5-4-3, Busulfan 3,2 mg/Kg D -4-3-2) starting on D-7 followed by peripheral blood or bone marrow infusion on day 0.
Who cannot join
- Cord blood HSCT.
- Antilymphocytic or anti thymocytic thymoglobulin as GvHD prophylaxis.
- Alentuzumab as GvHD prophylaxis.
- 3. Sirolimus as GvHD prophylaxis.
- 4. HIV positive, HVC, HVB active or latent at HSCT.
- 5. CMV prophylaxis with letermovir.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cytomegalovirus Infection, Indirect Effects and Mortality in Hematopoietic Stem Cell Transplantation With Cyclophosphamide Post-transplant
Multicentre, observational, retrospective study to analyze the differences in CMVi pattern and recurrences between two groups of allogeneic HSCT patients (haplo vs no haplo HSCT), with intervention both postransplant cyclophosphamide as GvHD prophylaxis, using a database with information from historical clinic data.
Read the detailed description
The overall aim of the study is to to analize CMVi after PTCy for GVHD prophylaxis, with a detailed description of CMVi and recurrences, direct and indirect consequences, in a HSCT population comparing two cohorts: haploidentical HSCT vs no haploidentical HSCT
- Conditions
- CMV Infection
- Keywords
- CMV, PT-CY, allogeneic stem cell transplantation
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic stem cell transplantation | Observational, no interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CMVi in HSCT with PT-Cy and CMVi requiring pre-emptive therapy (significant CMVi)
Measured: 1 year
Median time to CMVi
Measured: 1 year
Cumulative incidence of PET-CMVi by day +100, +180 and +365.
Measured: 1 year
Overall survival by day +100, +180 and +365
Measured: 1 year
Overall mortality by day +100, +180 and +365
Measured: 1 year
Non-relapse mortality by day +100, +180 and +365
Measured: 1 year
Secondary outcomes (6)
CMV indirect effects incidence
Hospital admissions, secondary infections, secondary toxicity.
Measured: 1 year
Incidence of CMVi recurrent episodes
Measured: 1 year
CMV disease
Measured: 1 year
CMV direct mortality
Measured: 1 year
Cumulative incidence of II-IV aGvHD
Measured: 1 year
Cumulative incidence of moderate-severe cGvHD
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start14 Feb 2020
- Primary completion17 Mar 2020
- Study completion17 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV InfectionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- MARIA JESUS PASCUAL, MD, Principal investigator, HOSPITAL REGIONAL MALAGA / BMT UNIT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315882
- Sponsor's protocol ID
- FIM-CIC-2020-01
- Acronym
- CY-CMV-2020
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2022
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Communication at the EBMT 2022 Prague congress
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytomegalovirus Infection, Indirect Effects and Mortality in Hematopoietic Stem Cell Transplantation With Cyclophosphamide Post-transplant
- ClinicalTrials.gov ID
- NCT05315882
- Acronym / sponsor ID
- CY-CMV-2020 / FIM-CIC-2020-01
- Conditions
- CMV Infection
- Keywords
- CMV, PT-CY, allogeneic stem cell transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Dec 2020 (actual)
- First posted
- 7 Apr 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.
Multicentre, observational, retrospective study to analyze the differences in CMVi pattern and recurrences between two groups of allogeneic HSCT patients (haplo vs no haplo HSCT), with intervention both postransplant cyclophosphamide as GvHD prophylaxis, using a database with information from historical clinic data.
Detailed description
The overall aim of the study is to to analize CMVi after PTCy for GVHD prophylaxis, with a detailed description of CMVi and recurrences, direct and indirect consequences, in a HSCT population comparing two cohorts: haploidentical HSCT vs no haploidentical HSCT
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogeneic stem cell transplantation | – | –Observational, no interventional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 300 patients with hematological malignancies under HSCT from matched sibling donors, unrelated matched and mistmatched donor and haploidentical family donor using PT-CY and CNI as GVHD prophylaxis
Key inclusion criteria (4 listed)
- Age > 18 years.
- Period of HSCT: January 1st 2013 to December 31th 2018.
- GvHD prophylaxis: Post-transplantation Cyclophosphamide (50 mg/Kg on days +3 and +4 or +3 and +5) and calcineurine inhibitors as GvHD prophylaxis.
- Conditioning chemotherapy regimen and source of stem cells: myeloablative or reduced intensity TBF (Thiotepa 5 mg/Kg D -7-6, Fludarabine 50 mg/m2 D -5-4-3, Busulfan 3,2 mg/Kg D -4-3-2) starting on D-7 followed by peripheral blood or bone marrow infusion on day 0.
Key exclusion criteria (7 listed)
- Cord blood HSCT.
- Antilymphocytic or anti thymocytic thymoglobulin as GvHD prophylaxis.
- Alentuzumab as GvHD prophylaxis.
- 3. Sirolimus as GvHD prophylaxis.
- 4. HIV positive, HVC, HVB active or latent at HSCT.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of CMVi in HSCT with PT-Cy and CMVi requiring pre-emptive therapy (significant CMVi)
Time frame: 1 year
Median time to CMVi
Time frame: 1 year
Cumulative incidence of PET-CMVi by day +100, +180 and +365.
Time frame: 1 year
Overall survival by day +100, +180 and +365
Time frame: 1 year
Overall mortality by day +100, +180 and +365
Time frame: 1 year
Non-relapse mortality by day +100, +180 and +365
Time frame: 1 year
6 secondary outcomes
CMV indirect effects incidence
Time frame: 1 year
Incidence of CMVi recurrent episodes
Time frame: 1 year
CMV disease
Time frame: 1 year
CMV direct mortality
Time frame: 1 year
Cumulative incidence of II-IV aGvHD
Time frame: 1 year
Cumulative incidence of moderate-severe cGvHD
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Individual participant dataSharing planned: Yes. Communication at the EBMT 2022 Prague congress
Related trials for CMV Infection
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The Natural History of Severe Viral Infections and Characterization of Immune Defects in Patients Without Known Immunocompromise
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TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
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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.
MARIA JESUS PASCUAL, MD principal investigator
HOSPITAL REGIONAL MALAGA / BMT UNIT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CMV Infection, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 7 Apr 2022. 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 Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of CMVi in HSCT with PT-Cy and CMVi requiring pre-emptive therapy (significant CMVi) (time frame: 1 year). The study lists 6 primary outcomes in all. 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 7 Apr 2022.