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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06362720
Acronym
CMV
Enrollment
158
Registered
2024-04-12
Start date
2024-05-01
Completion date
2024-12-31
Last updated
2024-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CMV Infection or Reactivation After Allogenic HSCT

Keywords

CMV infection, CMV reactivation, allogenic HSCT, GVHD prophylaxis, posttransplant cyclophosphamide (PTCy), cyclosporin A, methotrexate

Brief 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. 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.

Interventions

None listed

Sponsors

Siriraj Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of participants with CMV infection and reactivation14 days to 6 months after transplantNumber 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

Secondary

MeasureTime frameDescription
Median overall survivalat 2 years after transplant
cumulative incidence of relapseat 2 years after transplant
progression-free survivalat 2 years after transplant
GvHDat 2 years after transplantNumber of participants who have GvHD symptom
Averse eventsat 2 years after transplantAverse events of GVHD prophylaxis medication
non-relapsed mortalityat 2 years after transplant

Contacts

Primary ContactChutima Kunacheewa, MD
chutima.kua@mahidol.ac.th+6624197000
Backup ContactWeerapat Owatthanapanich, MD
weerapat.owa@mahidol.ac.th+6624197000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026