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 (CMV)

April 8, 2024 updated by: Chutima Kunacheewa, Siriraj Hospital

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 Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

158

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Insufficient data needed for analysis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
standard GVHD prophylaxis
calcineurin inhibitor (cyclosporin A ;CSA) and methotrexate (MTX)
posttransplant cyclophosphamide (PTCy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
14 days to 6 months after transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression-free survival
Time Frame: at 2 years after transplant
at 2 years after transplant
Median overall survival
Time Frame: at 2 years after transplant
at 2 years after transplant
cumulative incidence of relapse
Time Frame: at 2 years after transplant
at 2 years after transplant
non-relapsed mortality
Time Frame: at 2 years after transplant
at 2 years after transplant
GvHD
Time Frame: at 2 years after transplant
Number of participants who have GvHD symptom
at 2 years after transplant
Averse events
Time Frame: at 2 years after transplant
Averse events of GVHD prophylaxis medication
at 2 years after transplant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 12, 2024

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 720/2566(IRB2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Need a consensus from colleagues

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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