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

ConditionHematologic Diseases
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 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

This trial does not accept healthy volunteers

Qualifiers

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;

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 (ECOG) score ≥ 2 points;

Secondary tumors with merged activity;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

29 Participants
are divided into 1 treatment group
Group A: HLA-mismatch relatedExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Overall survival

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.

Time frame
1-year

Secondary outcomes

1

Neutrophil engraftment rate

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

Time frame
28 days
2

Platelet engraftment rate

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.

Time frame
28 days
3

Relapse

Cumulative incidence of relapse

Time frame
1-year
4

Cumulative incidence of relapse

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.

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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