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
• Interventions: Procedure: haplo-HCT; Procedure: haplo-cord HCT

• 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

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-10-22
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-24
• Last Update Posted: 2023-06-27

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

Arm && Interventions

Group	Intervention	Description
Haplo-HCT	haplo-HCT	people enrolled in this arm will receive a typical haploidentical donor HCT
Haplo-cord HCT	haplo-cord HCT	people enrolled in this arm will receive a coinfusion of cord blood unit in addition to a typical haploidentical donor HCT

Primary Outcome Measures

Name	Time	Method
Overall survival	3 year after randomization	estimated overall survival at 3 year

Secondary Outcome Measures

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

Trial Locations

Locations (5)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China

Hygeia Suzhou Yongding Hospital; 🇨🇳 Suzhou, Jiangsu, China

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

Soochow Hopes Hematology Hospital; 🇨🇳 Suzhou, Jiangsu, China

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China