Haplo HCT vs Haplo-cord HCT for Patients With AML

An Open-label, Multicenter, Randomized, Phase 3 Trial to Assess the Efficacy and Safety of Coinfusion With Unrelated Cord Blood Unit for Patients With Acute Myeloid Leukemia Undergoing Haploidentical Hematopoietic Cell Transplantation

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03719534

Enrollment

134

Registered

2018-10-25

Start date

2017-06-01

Completion date

2023-03-31

Last updated

2023-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukemia, Cord Blood Unit, Haplo-identical Donor, Hematopoietic Stem Cell Transplantation

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.

Interventions

PROCEDUREhaplo-HCT

HCT will be performed with a haploidentical donor

PROCEDUREhaplo-cord HCT

Haploidentical donor HCT will be performed with coinfusion of unrelated cord blood unit

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Overall survival	3 year after randomization	estimated overall survival at 3 year

Secondary

Measure	Time frame	Description
Progression-free survival	3 year after randomization	estimated progression-free survival at 3 year
Cumulative incidence of relapse	3 year after randomization	estimated cumulative incidence of nonrelapse mortality at 3 year
Cumulative incidence of non-relapse mortality	3 year after randomization	estimated nonrelapse mortality at 3 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026