Haplo HCT vs Haplo-cord HCT for Patients With AML

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Procedure: haplo-HCT
* Procedure: haplo-cord HCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 60 years old; Patients with AML; With available minimal residual disease (MRD) parameters assessed by flow cytometry (FCM) and/or quantitative real-time PCR (qPCR) Having no available HLA-matched donor, and willing to undergo haplo-HCT and having a suitable haploidentical donor With Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 Signing informed consent form, having the ability to comply with study and follow-up procedures Exclusion Criteria: Acute promyelocytic leukaemia (AML subtype M3) With other malignances Failing to acquire a suitable UCB unit With previous history of autologous haematopoietic cell transplantation (auto-HCT), allogeneic haematopoietic cell transplantation (allo-HCT) or chimaeric antigen receptor T-cell therapy With uncontrolled infection intolerant to haplo-HCT 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) In pregnancy or lactation period With any conditions not suitable for the trial (investigators' decision)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Haplo-HCT<br>people enrolled in this arm will receive a typical haploidentical donor HCT | Procedure: haplo-HCT<br>* HCT will be performed with a haploidentical donor<br>|
| Experimental: Haplo-cord HCT<br>people enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical donor HCT | Procedure: haplo-cord HCT<br>* Haploidentical donor HCT will be performed with coinfusion of unrelated cord blood unit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | estimated overall survival at 3 year | 3 year after randomization | 

Secondary Outcome Measures

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