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

NCT06362720 | Not Yet Recruiting

• 1 other identifier: 720/2566(IRB2)
• Study Type: observational
• Target: 158
• Locations: 0 countries
• Sites: N/A

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.

Conditions

CMV Infection or Reactivation After Allogenic HSCT

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• progression-free survival

  at 2 years after transplant

• Median overall survival

  at 2 years after transplant

• cumulative incidence of relapse

  at 2 years after transplant

• non-relapsed mortality

  at 2 years after transplant

• GvHD

  at 2 years after transplant

Study Arms (2)

standard GVHD prophylaxis

calcineurin inhibitor (cyclosporin A ;CSA) and methotrexate (MTX)

posttransplant cyclophosphamide (PTCy)

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients

You may qualify if:

• 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

You may not qualify if:

• Insufficient data needed for analysis

Sponsors & Collaborators

• Siriraj Hospital: lead

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Chutima Kunacheewa, MD

CONTACT

+6624197000; chutima.kua@mahidol.ac.th

Weerapat Owatthanapanich, MD

CONTACT

+6624197000; weerapat.owa@mahidol.ac.th

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 12, 2024
• Study Start: May 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04