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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Myeloma

• Study Type: Observational
• Enrollment (Estimated): 43

Contacts and Locations

• Study Contact: Name: Chutima Kunacheewa, MD; Phone Number: 66896790959; Email: chutima.kua@mahidol.ac.th
• Study Contact Backup: Name: Weerapat Owatthanapanich, MD; Phone Number: 66891081983; Email: weerapat.owa@mahidol.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

hematologic patients with haploidentical hematopoietic stem cell transplantation

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
register hematologic patients with haploidentical hematopoietic stem cell transplantation	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival rate	1 year
progression free 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
Rate of Neutrophil and platelet engraftment	during admission
Efficacy of donor specific antibody desensitization	during admission
Safety and complication of haploHSCT	5 years
Complication of viral, bacterial, and fungal infection	during admission
Viral reactivation	during admission
outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT	5 years
cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT	5 years

Collaborators and Investigators

• Sponsor: Siriraj Hospital
• Collaborators: Faculty of Medicine Siriraj Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: registry; haploidentical hematopoietic stem cell transplantation (haploHSCT)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Multiple Myeloma; Hematologic Diseases
• Other Study ID Numbers: 751/2563(IRB4)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Need a consensus from colleagues

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No