Clinical trial NCT06286228: Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease
Official title: Registry of Haploidentical Hematopoietic Stem Cell Transplantation in Adult With Hematologic Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Multiple Myeloma
Keywords: haploidentical hematopoietic stem cell transplantation (haploHSCT)
registry
Lead sponsor: Siriraj Hospital
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: hematologic patients with haploidentical hematopoietic stem cell transplantation

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.


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 \&lt;2g/dL, and left ventricular ejection fraction ≥50%
* age \&gt;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

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