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NCT Number: NCT06809699

Human Leukocyte Antigen (HLA) Mismatched Related Allogeneic Hematopoietic Stem Cell Transplantation

This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use human leukocyte antigen (HLA) mismatched donors. Ultimately, a HLA mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of these patients and truly enter the era of "everyone has a donor".

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China, 310003

Location status: Recruiting

Location contact

He Huang

PRINCIPAL_INVESTIGATOR

Yanmin Zhao, MD., PhD

CONTACT

[email protected]

+86 57187236706

Yanmin Zhao, MD., PhD

SUB_INVESTIGATOR

About this study

This study is a single center, prospective, single arm exploratory clinical trial that includes patients with hematological malignancies who are indicated for allogeneic hematopoietic stem cell transplantation (allo HSCT) but lack suitable donors. This project plans to use human leukocyte antigen (HLA) mismatched donors. Ultimately, a HLA mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of these patients and truly enter the era of "everyone has a donor".

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (18-60 years old) with hematological malignancies and indications for hematopoietic stem cell transplantation with no available related human leukocyte antigen (HLA) identical sibling donors;
  • No available donor with HLA high-resolution typing ≥ 9/10 or those who have difficulty finding donors due to urgent medical conditions;
  • No suitable HLA matching haploidentical donor available;
  • There is a suitable donor with mismatched HLA typing;
  • The subjects or their legal representatives shall sign an informed consent form before the start of the clinical study.

Exclusion criteria

  • Patients with severe liver and kidney function (alanine aminotransferase>2.5 times the upper limit of normal, blood creatinine>1.5 times the upper limit of normal) and cardiopulmonary dysfunction (New York Heart Association (NYHA) III/IV heart function, ejection fraction<50%, severe obstructive or restrictive ventilation dysfunction);
  • Merge active infections;
  • Eastern Cooperative Oncology Group (ECOG) score ≥ 2 points;
  • Secondary tumors with merged activity;
  • Severe central nervous system or mental illness leading to the inability to autonomously choose to enter or exit clinical trials;
  • Combine other allo HSCT contraindications.

Treatment and study plan

Busulfan (Busulfex)

Drug

For myeloablative conditioning: Busulfan (Bu,3.2 mg/kg/d IV -8d ~-6d) For reduced intensity conditioning: (Bu,3.2 mg/kg/d IV -7d~-5d)

Cyclophosphamide (CTX)

Drug

Cyclophosphamide is only used in myeloablative conditioning (Cy,1.8g/m2, -5d, -4d)

Fludarabine (Fludara)

Drug

For myeloablative conditioning: Fludarabine (Flu,30 mg/m2/d IV -6d ~ -2d) For reduced intensity conditioning: Fludarabine(Flu,30mg/m2 /d IV -10d~-5d)

Semustine (MeccNU)

Drug

For both myeloablative and reduced intensity conditioning: Semustine (MECCNU,250 mg/m2 orally-3d).

Primary outcomes

  1. Overall survival

    Time frame: 1-year

    Overall survival after allogeneic cell transplantation refers to the length of time a patient remains alive from the date of transplantation, regardless of disease status or complications.

Secondary outcomes

  1. Neutrophil engraftment rate

    Time frame: 28 days

    The neutrophil engraftment rate is assessed, and neutrophil engraftment is defined as achievement of an absolute neutrophil count (ANC) of ≥ 0.5 × 10⁹/L for three consecutive days

  2. Platelet engraftment rate

    Time frame: 28 days

    Platelet engraftment rate is assessed, and platelet engraftment is defined as achievement of a platelet count of ≥ 20 × 10⁹/L (or ≥ 50 × 10⁹/L in some definitions) without transfusion support for at least seven consecutive days.

  3. Relapse

    Time frame: 1-year

    Cumulative incidence of relapse

  4. Cumulative incidence of relapse

    Time frame: 1-year

    Progression-free survival after allogeneic cell transplantation refers to the length of time during which a patient remains alive without any signs of disease relapse or progression.

  5. Progression free survival

    Time frame: 1-year

    Progression-free survival after allogeneic cell transplantation refers to the length of time during which a patient remains alive without any signs of disease relapse or progression.

  6. GRFS

    Time frame: 1-year

    GRFS (Graft-versus-host disease-free, relapse-free survival) after allogeneic cell transplantation is the length of time a patient remains alive without experiencing significant graft-versus-host disease, disease relapse, or death.

Study contacts

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

Yanmin Zhao, MD., PhD

CONTACT

[email protected]

+86 87236706

Yishan Ye, MD., PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

He Huang

Other

Registry information

Official study title

A Prospective Single-arm Trial on Human Leukocyte Antigen (HLA) Mismatched Related Allogeneic Hematopoietic Stem Cell Transplantation

Acronym: HIGHT

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

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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