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

ConditionHematologic Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHe Huang

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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)

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: HLA mismatchExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Overall survival

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.

Time frame
1-year

Secondary outcomes

1

Neutrophil engraftment rate

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.

Time frame
28-days
2

Platelet engraftment rate

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.

Time frame
28-days
3

GVHD

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

Time frame
180 days and 2 year
4

Relapse

Cumulative incidence of disease relapse after transplantation.

Time frame
1-year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

He Huang

Lead sponsor

Zhejiang University

Sponsor institution

Source ClinicalTrials.gov
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