Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease

Siriraj Hospital0 sites43 target enrollmentApril 1, 2024

ConditionsMultiple Myeloma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Myeloma
Sponsor: Siriraj Hospital
Enrollment: 43
Primary Endpoint: register hematologic patients with haploidentical hematopoietic stem cell transplantation
Status: Not yet recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The goal of this observational study is to register hematologic patients with haploidentical hematopoietic stem cell transplantation (haploHSCT). The main questions it aims to answer are:

1-year progression free survival rate
1-year overall survival rate
Graft-versus-host free relapsed free survival at 30-day, 100-day, 180-day and 1-year
Chronic Graft-versus-host free relapsed free survival at 180-day and 1-year
Rate of Neutrophil and platelet engraftment
Efficacy of donor specific antibody desensitization
Relapsed rate
Primary and late graft failure
Safety and complication of haploHSCT
Complication of viral, bacterial, and fungal infection
Viral reactivation
Comparison outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT
Comparison cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.

Registry

clinicaltrials.gov

Start Date

April 1, 2024

End Date

April 1, 2030

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Siriraj Hospital

Responsible Party

Principal Investigator

Chutima Kunacheewa

lecturer

Siriraj Hospital

Eligibility Criteria

Inclusion Criteria

•Patients diagnosed with hematologic diseases indicated for treatment with haploidentical hematopoietic stem cell transplantation including
•Myeloid diseases (acute myeloblastic leukemia, myelodysplastic syndrome, chronic myelocytic leukemia, classical and non-classical myeloproliferative disorders)
•Lymphoid disease (acute lymphoblastic leukemia, lymphoma)
•severe aplastic anemia
•Unable to find a matched sibling donor (MSD) or matched unrelated donor (MUD), and no alternative treatments
•Eastern Cooperative Oncology Group (ECOG) 0-2
•normal AST and ALT, creatinine \<2g/dL, and left ventricular ejection fraction ≥50%
•age \>18 years
•Capable of informed consent and provision of written informed consent before any study procedures
•Capable of attending all study visits according to the study schedule

Exclusion Criteria

•HIV infection, active hepatitis B, active hepatitis C
•active infection
•history of other malignancy except basal cell carcinoma and carcinoma of the cervix in situ
•A pregnant woman and/or refusal of contraception

Outcomes

Primary Outcomes

Time Frame: 5 years

Secondary Outcomes

Viral reactivation(during admission)
overall survival rate(1 year)
Relapsed rate(5 years)
progression free survival rate(1 year)
Chronic Graft-versus-host free relapsed free survival(at 180-day and 1-year)
Rate of Neutrophil and platelet engraftment(during admission)
cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT(5 years)
Primary and late graft failure(5 years)
Efficacy of donor specific antibody desensitization(during admission)
Complication of viral, bacterial, and fungal infection(during admission)
outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT(5 years)
Safety and complication of haploHSCT(5 years)