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

Not yet recruiting

• Conditions: Multiple Myeloma

• Registration Number: NCT06286228
• Lead Sponsor: Siriraj Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-22
• Last Update Submitted: 2024-02-28
• Study First Posted: 2024-02-29
• Last Update Posted: 2024-03-01
• Study Start: 2024-04-01
• Primary Completion: 2029-04-01
• Study Completion: 2030-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
register hematologic patients with haploidentical hematopoietic stem cell transplantation	5 years

Secondary Outcome Measures

Name	Time	Method
Complication of viral, bacterial, and fungal infection	during admission
outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT	5 years
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
Viral reactivation	during admission
Efficacy of donor specific antibody desensitization	during admission
Safety and complication of haploHSCT	5 years