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NCT Number: NCT06809712

Human Leukocyte Antigen (HLA) Mismatched Unrelated 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 highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.

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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, 310003, China

Location status: Recruiting

Location contact

He Huang

PRINCIPAL_INVESTIGATOR

Yishan Ye

CONTACT

[email protected]

+86 57187236706

Yishan Ye, 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 highly mismatched unrelated HLA mismatched donors. Ultimately, an unrelated human leukocyte antigen (HLA) mismatched allo HSCT transplantation plan will be established to improve the disease prognosis of this group of patients and truly enter the era of "everyone has a donor" for allo HSCT.

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;
  • Non blood donors without human leukocyte antigen (HLA) high-resolution typing ≥ 9/10, or those who have difficulty finding non blood donors due to urgent medical conditions;
  • No suitable HLA matching haploidentical donor available;
  • There are suitable unrelated HLA mismatched (HLA high-resolution typing<9/10) donors;
  • 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 Performance Status (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 hematopoietic stem cell transplantation (HSCT) contraindications.

Treatment and study plan

Busulfan (Busulfex)

Drug

Myeloablative conditioning: Busulfan (Bu,3.2 mg/kg/d IV -8d ~-6d); Reduced intensity conditioning: Busulfan (Bu,3.2 mg/kg/d IV -7d~-5d);

Cyclophosphamide (CTX)

Drug

Myeloablative conditioning: Cyclophosphamide (Cy,1.8g/m2, -5d, -4d) Cyclophosphamide is not used for reduced intensity conditioning

Fludarabine (Fludara)

Drug

Myeloablative conditioning: Fludarabine (Flu,30 mg/m2/d IV -6d ~ -2d); 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 (OS) after allogeneic hematopoietic cell transplantation is defined as the proportion of patients who are alive at a specified time point following the transplantation, regardless of disease status or cause of death.

Secondary outcomes

  1. Neutrophil engraftment rate

    Time frame: 28-days

    The 28-day neutrophil engraftment rate is assessed, with neutrophil engraftment 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

    The 28-day platelet engraftment rate is assessed, with platelet engraftment defined as achievement of a platelet count of ≥ 20 × 10⁹/L without transfusion support for at least seven consecutive days.

  3. GVHD

    Time frame: 180 days and 2 year

    Cumulative incidence of aGvHD and cGvHD in different target organs and overall population.

  4. Relapse

    Time frame: 1-year

    Cumulative incidence of disease relapse after transplantation.

  5. Progression-free survival

    Time frame: 1-year

    Progression-free survival (PFS) after allogeneic hematopoietic cell transplantation is defined as the length of time a patient survives without evidence of disease progression or relapse following the transplantation.

  6. Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS)

    Time frame: 1-year

    Graft-versus-host disease (GVHD)-free, relapse-free survival (GRFS) after allogeneic hematopoietic cell transplantation is defined as the time a patient survives without experiencing grade III-IV acute GVHD, severe chronic GVHD, relapse, or death.

Study contacts

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

Yishan Ye, MD., PhD

CONTACT

[email protected]

+8618268068056

Sponsors and collaborators

Lead sponsor

He Huang

Other

Registry information

Official study title

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

Acronym: MIGHT

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 5, 2025
Registry last updated
Jun 9, 2026

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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