MedPath

Haplo HCT vs Haplo-cord HCT for Patients With AML

Phase 3
Completed
Conditions
Hematopoietic Stem Cell Transplantation
Haplo-identical Donor
Cord Blood Unit
Acute Myeloid Leukemia
Registration Number
NCT03719534
Lead Sponsor
The First Affiliated Hospital of Soochow University
Brief Summary

Patients who have acute myeloid leukemia and will undergo haplo-identical donor hematopoeitic cell transplantation (haplo HCT) are potential candidates of this trial. Participants will randomized into two arms: Arm A will undergo a typical haplo HCT, while Arm B will receive an coinfusion of an unrelated cord blood unit (haplo-cord HCT) in addition to Arm A. Progression-free survival, overall survival, cumulative incidence of relapse and nonrelapse mortality will be recorded as endpoints.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
134
Inclusion Criteria
  1. Age 18 to 60 years old;
  2. Patients with AML;
  3. With available minimal residual disease (MRD) parameters assessed by flow cytometry (FCM) and/or quantitative real-time PCR (qPCR)
  4. Having no available HLA-matched donor, and willing to undergo haplo-HCT and having a suitable haploidentical donor
  5. With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3
  6. Signing informed consent form, having the ability to comply with study and follow-up procedures
Exclusion Criteria
  1. Acute promyelocytic leukaemia (AML subtype M3)

  2. With other malignances

  3. Failing to acquire a suitable UCB unit

  4. With previous history of autologous haematopoietic cell transplantation (auto-HCT), allogeneic haematopoietic cell transplantation (allo-HCT) or chimaeric antigen receptor T-cell therapy

  5. With uncontrolled infection intolerant to haplo-HCT

  6. With severe organ dysfunction

    • Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
    • Respiratory failure (PaO2≤60 mmHg)
    • Hepatic abnormalities (total bilirubin≥2×upper limit of normal [ULN], alanine aminotransferase or aspartate aminotransferase≥2×ULN)
    • Renal dysfunction (creatinine≥2 mg/dL creatinine clearance rate < 30 mL/min)
  7. In pregnancy or lactation period

  8. With any conditions not suitable for the trial (investigators' decision)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Overall survival3 year after randomization

estimated overall survival at 3 year

Secondary Outcome Measures
NameTimeMethod
Progression-free survival3 year after randomization

estimated progression-free survival at 3 year

Cumulative incidence of non-relapse mortality3 year after randomization

estimated nonrelapse mortality at 3 year

Cumulative incidence of relapse3 year after randomization

estimated cumulative incidence of nonrelapse mortality at 3 year

Trial Locations

Locations (5)

The Second People's Hospital of Huai'an

🇨🇳

Huai'an, Jiangsu, China

The First Affiliated Hospital of Soochow University

🇨🇳

Suzhou, Jiangsu, China

Soochow Hopes Hematology Hospital

🇨🇳

Suzhou, Jiangsu, China

Hygeia Suzhou Yongding Hospital

🇨🇳

Suzhou, Jiangsu, China

The First Affiliated Hospital, Zhejiang University School of Medicine

🇨🇳

Hangzhou, Zhejiang, China

The Second People's Hospital of Huai'an
🇨🇳Huai'an, Jiangsu, China

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.