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NCT Number: NCT06208137

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

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

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Key information

Conditions

Transplant-Related Disorder

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

Location status: Recruiting

Location contact

Yahui Feng, MS

CONTACT

[email protected]

022-23909051

About this study

This study aims to prospectively evaluate the effectiveness of the Composite Immune Risk Score in real-world clinical setting.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Health monitoring and regular return follow-up reminders

Behavioral

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

Primary outcomes

  1. Survival

    Time frame: 1.5 years after transplantation

    Overall survival during 1.5 years after transplantation

Secondary outcomes

  1. Non-relapse mortality rate

    Time frame: 1.5 years after transplantation

    Non-relapse mortality rate during 1.5 years after transplantation

  2. Incidence of infections

    Time frame: 1.5 years after transplantation

    Infections during 1.5 years after transplantation

  3. Immune cell count

    Time frame: 1.5 years after transplantation

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

Study contacts

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

Yahui Feng, MS

CONTACT

[email protected]

022-23909051

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study title

Using the Composite Immune Risk Score to Assess and Modulate the Patient's Immune Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation, a Prospective, Multicenter, Randomized Controlled Study.

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jan 17, 2024
Registry last updated
Aug 13, 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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