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

NCT ID: NCT06286228

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2030-04-01

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.

Conditions

Multiple Myeloma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with hematologic diseases indicated for treatment with haploidentical hematopoietic stem cell transplantation including

1. Myeloid diseases (acute myeloblastic leukemia, myelodysplastic syndrome, chronic myelocytic leukemia, classical and non-classical myeloproliferative disorders)

2. Lymphoid disease (acute lymphoblastic leukemia, lymphoma)

3. 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
• Female subjects who is childbearing potential must have a negative result for pregnancy test

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Siriraj Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chutima Kunacheewa

lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Chutima Kunacheewa, MD

Role: CONTACT

chutima.kua@mahidol.ac.th

66896790959

Weerapat Owatthanapanich, MD

Role: CONTACT

weerapat.owa@mahidol.ac.th

66891081983

Other Identifiers

751/2563(IRB4)

Identifier Type: -

Identifier Source: org_study_id