Clinical trial NCT06362720: 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
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CMV Infection or Reactivation After Allogenic HSCT
Keywords: CMV infection
CMV reactivation
allogenic HSCT
GVHD prophylaxis
posttransplant cyclophosphamide (PTCy)
cyclosporin A
methotrexate
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 158
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with CMV infection and reactivation
timeFrame: 14 days to 6 months after transplant
Secondary outcomes:
measure: progression-free survival
timeFrame: at 2 years after transplant
measure: Median overall survival
timeFrame: at 2 years after transplant
measure: cumulative incidence of relapse
timeFrame: at 2 years after transplant
measure: non-relapsed mortality
timeFrame: at 2 years after transplant
measure: GvHD
timeFrame: at 2 years after transplant
measure: Averse events
timeFrame: at 2 years after transplant
Other outcomes:
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