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

Last updated: January 30, 2025
Sponsor: He Huang
Overall Status: Active - Recruiting

Phase

1

Condition

Hematological Disorders

Red Blood Cell Disorders

Treatment

Fludarabine (Fludara)

Busulfan (Busulfex)

Semustine (MeCCNU)

Clinical Study ID

NCT06809699
MMR-001
  • Ages 18-60
  • All Genders

Study Summary

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".

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients (18-60 years old) with hematological malignancies and indications forhematopoietic stem cell transplantation with no available related human leukocyteantigen (HLA) identical sibling donors;

  • No available donor with HLA high-resolution typing ≥ 9/10 or those who havedifficulty 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 formbefore the start of the clinical study.

Exclusion

Exclusion Criteria:

  • Patients with severe liver and kidney function (alanine aminotransferase>2.5 timesthe upper limit of normal, blood creatinine>1.5 times the upper limit of normal) andcardiopulmonary dysfunction (New York Heart Association (NYHA) III/IV heartfunction, ejection fraction<50%, severe obstructive or restrictive ventilationdysfunction);

  • 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 toautonomously choose to enter or exit clinical trials;

  • Combine other allo HSCT contraindications.

Study Design

Total Participants: 29
Treatment Group(s): 4
Primary Treatment: Fludarabine (Fludara)
Phase: 1
Study Start date:
August 04, 2022
Estimated Completion Date:
October 31, 2027

Study 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 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".

Connect with a study center

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, 310003
    China

    Active - Recruiting

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