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NCT Number: NCT04689750

Donor CHIP and Allogeneic HSCT Outcome

Current data on the impact of donor CHIP on long-term recipient outcome remain largely speculative. Data on the impact of donor CHIP including on allograft function, immunologic dysfunction, graft versus host disease (GVHD), disease relapse and survival across various donor populations are scarce. This is a retrospective-prospective cohort study designed to determine the association between donor gene mutations and outcome following allogeneic HSCT.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The University of Hong Kong

Hong Kong

Location status: Recruiting

Location contact

Harinder Gill, MD

CONTACT

[email protected]

85222554542

Yok-Lam Kwong, MD

SUB_INVESTIGATOR

About this study

This is a single centre prospective and retrospective cohort study. This study involves allo-HSCT recipients and their donors at Queen Mary Hospital, Hong Kong. Information on the presence of gene mutations in donor peripheral blood or bone marrow sample; gene mutations in recipient peripheral blood or bone marrow post-allo-HSCT; and donor and recipient outcome will be collected in either prospective, partial-prospective/retrospective or retrospective manner. The information will be used to determine the association between the presence of clonal haematopoiesis in the donor and recipient outcome following allo-HSCT.

Data will be collected through routine clinical visits and/or reviewing medical records. Data will be collected at the time of peripheral blood stem cells (PBSC) or bone marrow stem cells donation, at the time of allo-HSCT, one month post-allo-HSCT and every 6 months thereafter until death/study termination.

Genetic profile of donors will be collected at the time of PBSC or BM stem cell donation. Genetic profile of recipients will be collected at 1-month, 6-month, 12-month post-HSCT and at time of relapse or occurrence of leukaemia.

Gene mutations and pathogenic gene fusion will be determined in the peripheral blood and/or marrow samples by next-generation sequencing (NGS) using a myeloid-gene panel and nanopore long-read sequencing.

Who can participate

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

Inclusion criteria

  • Adult aged 18 year or above
  • Donor and recipient of allo-HSCT
  • In prospective and partial prospective/retrospective case, subjects who have provided a signed written informed consent. In retrospective case, subjects who had provided a previously signed written informed consent on:
  • voluntary provision of clinical data, and
  • voluntary provision of archived/remaining specimens for genetic analysis, and
  • authorizing storage and usage of archived/remaining specimens for any further analysis

Exclusion criteria

  • Autologous peripheral blood stem cells or bone marrow stem cell donors for autologous HSCT

Treatment and study plan

Next generation sequencing

Diagnostic Test

Genetic profile of donors will be collected at the time of PBSC or BM stem cell donation. Genetic profile of recipients will be collected at 1-month, 6-month, 12-month post-HSCT and at time of relapse or occurrence of leukaemia.

Gene mutations and pathogenic gene fusion will be determined in the peripheral blood and/or marrow samples by next-generation sequencing (NGS) using a myeloid-gene panel and nanopore long-read sequencing.

Primary outcomes

  1. Overall survival (OS) of the recipient.

    Time frame: 5 years

    This is defined as the time (in months) from the date of allo-HSCT to death from any cause (event), latest follow-up (censor) or study termination.

  2. Progression-free survival (PFS) of the recipient.

    Time frame: 5 years

    This is defined as the time (in months) from the date of allo-HSCT to relapse/progression (event), death, latest follow-up or study termination.

Secondary outcomes

  1. Acute and chronic GVHD

    Time frame: 5 years

    The occurrence of acute and/or chronic graft-versus-host disease

  2. Leukemia of donor origin

    Time frame: 5 years

    The occurrence of donor cell derived MDS/AML in the recipient following allogeneic HSCT

  3. Cardiac complications

    Time frame: 5 years

    The occurrence of arrthymias, pericardial disease, coronary artery disease, myocardial dysfunction, pulmonary hypertension

  4. Pulmonary complications

    Time frame: 5 years

    The occurrence of bronchiolitis obliterans, bronchiolitis obliterans with organizing pneumonia.

Study contacts

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

Harinder Gill, MD

CONTACT

[email protected]

+852 22554542

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

Impact of Donor Clonal Haematopoiesis of Indeterminate Potential (CHIP) on Recipient Outcome Following Allogeneic Haematopoietic Stem Cell Transplantation (Allo-HSCT)

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 30, 2020
Registry last updated
Oct 4, 2022

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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