Haplo HCT vs Haplo-cord HCT for Patients With AML

Acute Myeloid Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719534
• Other study ID #: SZ3703
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2017
• Est. completion date: March 31, 2023

Study information

• Verified date: June 2023
• Source: The First Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Haplo-identical Donor
• Hematopoietic Stem Cell Transplantation
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Procedure:
• haplo-HCT
HCT will be performed with a haploidentical donor
• haplo-cord HCT
Haploidentical donor HCT will be performed with coinfusion of unrelated cord blood unit

Locations

Country	Name	City	State
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	Hygeia Suzhou Yongding Hospital	Suzhou	Jiangsu
China	Soochow Hopes Hematology Hospital	Suzhou	Jiangsu
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (5)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	Hygeia Suzhou Yongding Hospital, Soochow Hopes Hematology Hospital, The Second People's Hospital of Huai'an, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	estimated overall survival at 3 year	3 year after randomization
Secondary	Progression-free survival	estimated progression-free survival at 3 year	3 year after randomization
Secondary	Cumulative incidence of relapse	estimated cumulative incidence of nonrelapse mortality at 3 year	3 year after randomization
Secondary	Cumulative incidence of non-relapse mortality	estimated nonrelapse mortality at 3 year	3 year after randomization