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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational [Patient Registry]
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06286228
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Siriraj Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Multiple Myeloma

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Chutima Kunacheewa, MD

chutima.kua@mahidol.ac.th

66896790959

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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