CMV Infection or Reactivation After Allogenic HSCTCMVNCT06362720
The Comparison the CMV Infection and Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Between Standard Regimen, Methotrexate Plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen
An observational study of CMV Infection or Reactivation After Allogenic HSCT, run by Siriraj Hospital.
Trial summary
The goal of this observational study is to compare the CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- CMV Infection or Reactivation After Allogenic HSCT
- How many people
- 158 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Dec 2024
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients
Who may be able to join
- Age more than 15 years
- Diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome (MDS), myelofibrosis primary and/or post PV/ET myelofibrosis, aplastic anemia, lymphoma, or paroxysmal nocturnal hemoglobinuria
- Received HLA-matched related (MSD-HSCT) or unrelated allo-SCT (MUD-HSCT) or haploidentical hematopoietic stem cell transplantation
Who cannot join
- Insufficient data needed for analysis
Trial locations and contacts
No sites are listed yet.
About this study
The goal of this observational study is to compare the CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen. The main questions it aims to answer are:
- How do CMV infection and reactivation differ between Allo-SCT patients who received a standard regimen versus those who received a Post-transplant Cyclophosphamide-based regimen?
- progression-free survival, Median overall survival, cumulative incidence of relapse, non-relapsed mortality (NRM) and GvHD at 2 years after Allo-SCT
- The impact of CMV infection and CMV reactivation on progression-free survival, overall survival, and NRM
- Averse events of GVHD prophylaxis medication Participants will be collected the data of treatment and treatment response during transplant until 2 years after transplant from hospital medical record.
- Keywords
- CMV infection, CMV reactivation, allogenic HSCT, GVHD prophylaxis, posttransplant cyclophosphamide (PTCy), cyclosporin A, methotrexate
- 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 |
|---|---|---|
| standard GVHD prophylaxis | calcineurin inhibitor (cyclosporin A ;CSA) and methotrexate (MTX) | |
| posttransplant cyclophosphamide (PTCy) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with CMV infection and reactivation
Number of participants with CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen
Measured: 14 days to 6 months after transplant
Secondary outcomes (6)
progression-free survival
Measured: at 2 years after transplant
Median overall survival
Measured: at 2 years after transplant
cumulative incidence of relapse
Measured: at 2 years after transplant
non-relapsed mortality
Measured: at 2 years after transplant
GvHD
Number of participants who have GvHD symptom
Measured: at 2 years after transplant
Averse events
Averse events of GVHD prophylaxis medication
Measured: at 2 years after transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CMV Infection or Reactivation After Allogenic HSCTStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chutima Kunacheewa, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362720
- Sponsor's protocol ID
- 720/2566(IRB2)
- Acronym
- CMV
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Need a consensus from colleagues
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison the CMV Infection and Reactivation After Allogeneic Hematopoietic Stem Cell Transplantation Between Standard Regimen, Methotrexate Plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen
- ClinicalTrials.gov ID
- NCT06362720
- Acronym / sponsor ID
- CMV / 720/2566(IRB2)
- Keywords
- CMV infection, CMV reactivation, allogenic HSCT, GVHD prophylaxis, posttransplant cyclophosphamide (PTCy), cyclosporin A, methotrexate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Apr 2024 (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.
The goal of this observational study is to compare the CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen. The main questions it aims to answer are:
- How do CMV infection and reactivation differ between Allo-SCT patients who received a standard regimen versus those who received a Post-transplant Cyclophosphamide-based regimen?
- progression-free survival, Median overall survival, cumulative incidence of relapse, non-relapsed mortality (NRM) and GvHD at 2 years after Allo-SCT
- The impact of CMV infection and CMV reactivation on progression-free survival, overall survival, and NRM
- Averse events of GVHD prophylaxis medication Participants will be collected the data of treatment and treatment response during transplant until 2 years after transplant from hospital medical record.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard GVHD prophylaxis | – | –calcineurin inhibitor (cyclosporin A ;CSA) and methotrexate (MTX) |
| posttransplant cyclophosphamide (PTCy) | – | – |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients
Key inclusion criteria (3 listed)
- Age more than 15 years
- Diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome (MDS), myelofibrosis primary and/or post PV/ET myelofibrosis, aplastic anemia, lymphoma, or paroxysmal nocturnal hemoglobinuria
- Received HLA-matched related (MSD-HSCT) or unrelated allo-SCT (MUD-HSCT) or haploidentical hematopoietic stem cell transplantation
Key exclusion criteria (1 listed)
- Insufficient data needed for analysis
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
Number of participants with CMV infection and reactivation
Time frame: 14 days to 6 months after transplant
Number of participants with CMV infection and reactivation after allogeneic hematopoietic stem cell transplantation Between Standard Regimen, Methotrexate plus Cyclosporin A, and Post-transplant Cyclophosphamide-based Regimen
6 secondary outcomes
progression-free survival
Time frame: at 2 years after transplant
Median overall survival
Time frame: at 2 years after transplant
cumulative incidence of relapse
Time frame: at 2 years after transplant
non-relapsed mortality
Time frame: at 2 years after transplant
GvHD
Time frame: at 2 years after transplant
Averse events
Time frame: at 2 years after transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: Undecided. Need a consensus from colleagues
Related trials for CMV Infection or Reactivation After Allogenic HSCT
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RecruitingEarly Phase 1
Donor Virus-Specific CMV or AdV CTL to Treat CMV or AdV Reactivation or Disease After Solid Organ or HCT
Allogeneic Hematopoietic Stem Cell Transplantation Recipient, Cytomegalovirus
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of CMV Infection or Reactivation After Allogenic HSCT, run by Siriraj Hospital.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chutima Kunacheewa, MD (+6624197000, chutima.kua@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with CMV infection and reactivation (time frame: 14 days to 6 months after transplant). 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 12 Apr 2024.