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

June 5, 2026 updated by: He Huang

A Prospective Single-arm Trial on 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

29

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hangzhou, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Principal Investigator:
          • He Huang
        • Contact:
        • Sub-Investigator:
          • Yishan Ye, MD., PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HLA mismatch
Myeloablative conditioning regimen was used when patient is below 50 and with a HCT-CI score <2; Reduced intensity conditioning regimen was used when patient is over 50 or with HCT-CI score ≥2.
Drug: Busulfan (Busulfex)
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);
Drug: Cyclophosphamide (CTX)
Myeloablative conditioning: Cyclophosphamide (Cy，1.8g/m2, -5d, -4d) Cyclophosphamide is not used for reduced intensity conditioning
Drug: Fludarabine (Fludara)
Myeloablative conditioning: Fludarabine (Flu，30 mg/m2/d IV -6d ~ -2d); Reduced intensity conditioning: Fludarabine (Flu，30mg/m2 /d IV -10d~-5d);
Drug: Semustine (MeccNU)

For both myeloablative and reduced intensity conditioning:

Semustine (MeCCNU: 250 mg/m2 orally-3d)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28-days
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.
28-days
GVHD
Time Frame: 180 days and 2 year
Cumulative incidence of aGvHD and cGvHD in different target organs and overall population.
180 days and 2 year
Relapse
Time Frame: 1-year
Cumulative incidence of disease relapse after transplantation.
1-year
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.
1-year
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.
1-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Huang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2022

Primary Completion (Estimated)

October 31, 2026

Study Completion (Estimated)

October 31, 2027

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

January 30, 2025

First Posted (Actual)

February 5, 2025

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMU-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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