Using the Composite Immune Risk Score to Assess and Modulate the Patient's Post-transplant Immune Reconstitution.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

To assess the effectiveness of interventions including health monitoring and regular return follow-up reminders for patients with a high Composite Immune Risk Score.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Patients must be ≥ 16 years of age;

2) Patients receiving haploidentical allo-HSCT;

3) Patients have to sign an informed consent form before the start of the research procedure.

Disqualifiers

1) Tandem transplantation or multiple transplantations;

2) Mental or other medical conditions that make the patients unable to comply with the research treatment and monitoring requirements;

3) Patients who are ineligible for the study due to other factors, or will bear great risk if participating in the study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Health monitoring and regular return follow-up reminders

    Behavioral

    Health monitoring \& reminders for blood tests and follow-up visits until 1 year post-transplant

Treatment groups

456 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Survival

Overall survival during 1.5 years after transplantation

Time frame
1.5 years after transplantation

Secondary outcomes

1

Non-relapse mortality rate

Non-relapse mortality rate during 1.5 years after transplantation

Time frame
1.5 years after transplantation
2

Incidence of infections

Infections during 1.5 years after transplantation

Time frame
1.5 years after transplantation
3

Immune cell count

Data on immune cell count will be collected during 1.5 years after transplantation

Time frame
1.5 years after transplantation

Other outcomes

Sponsors and contacts

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