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

Multiple Myeloma Clinical Trial

— Haplo  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06286228
• Other study ID #: 751/2563(IRB4)
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: April 1, 2030

Study information

• Verified date: February 2024
• Source: Siriraj Hospital
• Contact: Chutima Kunacheewa, MD
• Phone: 66896790959
• Email: chutima.kua[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 43
• Est. completion date: April 1, 2030
• Est. primary completion date: April 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Diseases
• Multiple Myeloma

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Siriraj Hospital	Faculty of Medicine Siriraj Hospital

Outcome

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