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

NCT06286228 | Not Yet Recruiting

• 1 other identifier: 751/2563(IRB4)
• Study Type: observational
• Target: 43
• Locations: 0 countries
• Sites: N/A

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

Keywords

haploidentical hematopoietic stem cell transplantation (haploHSCT); registry

Outcome Measures

Primary Outcomes (1)

• register hematologic patients with haploidentical hematopoietic stem cell transplantation

  5 years

Secondary Outcomes (12)

• progression free survival rate

  1 year

• overall survival rate

  1 year

• Chronic Graft-versus-host free relapsed free survival

  at 180-day and 1-year

• Relapsed rate

  5 years

• Primary and late graft failure

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

hematologic patients with haploidentical hematopoietic stem cell transplantation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siriraj Hospital: lead

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Chutima Kunacheewa, MD

CONTACT

66896790959; chutima.kua@mahidol.ac.th

Weerapat Owatthanapanich, MD

CONTACT

66891081983; weerapat.owa@mahidol.ac.th

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 1, 2024

Record last verified: 2024-02