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 Infection or Reactivation After Allogenic HSCT Clinical Trial

— CMV  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06362720
• Other study ID #: 720/2566(IRB2)
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: Siriraj Hospital
• Contact: Chutima Kunacheewa, MD
• Phone: +6624197000
• Email: chutima.kua[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 158
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CMV Infection or Reactivation After Allogenic HSCT
• Communicable Diseases
• Cytomegalovirus Infections
• Infections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	14 days to 6 months after transplant
Secondary	progression-free survival		at 2 years after transplant
Secondary	Median overall survival		at 2 years after transplant
Secondary	cumulative incidence of relapse		at 2 years after transplant
Secondary	non-relapsed mortality		at 2 years after transplant
Secondary	GvHD	Number of participants who have GvHD symptom	at 2 years after transplant
Secondary	Averse events	Averse events of GVHD prophylaxis medication	at 2 years after transplant