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

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.

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia; Hematopoietic Stem Cell Transplantation; Haplo-identical Donor; Cord Blood Unit
• Intervention / Treatment: Procedure: haplo-HCT; Procedure: haplo-cord HCT

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jia Chen, M.D., Ph.D.; Phone Number: +86 512 67781856; Email: chenjiasuzhou@gmail.com

Study Locations

• China
  • Jiangsu
    • Huai'an, Jiangsu, China, 223000
      • The Second People's Hospital of Huai'an
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
    • Suzhou, Jiangsu, China, 215100
      • Soochow Hopes Hematology Hospital
    • Suzhou, Jiangsu, China, 215200
      • Hygeia Suzhou Yongding Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University
• Collaborators: Zhejiang University; The Second People's Hospital of Huai'an; Soochow Hopes Hematology Hospital; Hygeia Suzhou Yongding Hospital
• Investigators: Principal Investigator: Depei Wu, M.D., Ph.D., The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: October 22, 2018
• First Submitted That Met QC Criteria: October 23, 2018
• First Posted (Actual): October 25, 2018

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 24, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
• Other Study ID Numbers: SZ3703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No