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Donor CHIP and Allogeneic HSCT Outcome

ConditionClonal Hematopoiesis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult aged 18 year or above

Donor and recipient of allo-HSCT

voluntary provision of clinical data, and

voluntary provision of archived/remaining specimens for genetic analysis, and

Disqualifiers

None

Trial population

This study will involve 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

850 Participants
are divided into 1 treatment group
Group A: Allogeneic HSCT recipients and donors1 intervention

Trial outcomes

Primary outcomes

1

Overall survival (OS) of the recipient.

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.

Time frame
5 years
2

Progression-free survival (PFS) of the recipient.

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.

Time frame
5 years

Secondary outcomes

1

Acute and chronic GVHD

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

Time frame
5 years
2

Leukemia of donor origin

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

Time frame
5 years
3

Cardiac complications

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

Time frame
5 years
4

Pulmonary complications

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

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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