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NCT Number: NCT06286228

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Primary outcomes

  1. register hematologic patients with haploidentical hematopoietic stem cell transplantation

    Time frame: 5 years

Secondary outcomes

  1. progression free survival rate

    Time frame: 1 year

  2. overall survival rate

    Time frame: 1 year

  3. Chronic Graft-versus-host free relapsed free survival

    Time frame: at 180-day and 1-year

  4. Relapsed rate

    Time frame: 5 years

  5. Primary and late graft failure

    Time frame: 5 years

  6. Rate of Neutrophil and platelet engraftment

    Time frame: during admission

  7. Efficacy of donor specific antibody desensitization

    Time frame: during admission

  8. Safety and complication of haploHSCT

    Time frame: 5 years

  9. Complication of viral, bacterial, and fungal infection

    Time frame: during admission

  10. Viral reactivation

    Time frame: during admission

  11. outcomes between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT

    Time frame: 5 years

  12. cost-effectiveness of treatment between matched sibling donor (MSD) HSCT and matched unrelated donor (MUD) HSCT

    Time frame: 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Chutima Kunacheewa, MD

CONTACT

[email protected]

66896790959

Weerapat Owatthanapanich, MD

CONTACT

[email protected]

66891081983

Sponsors and collaborators

Lead sponsor

Siriraj Hospital

Other

Registry information

Acronym: Haplo

Important dates

Study start
2024
Primary completion
2029
Study completion
2030
First posted
Feb 29, 2024
Registry last updated
Mar 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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