NCT03719534

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2017

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

June 27, 2023

Status Verified

June 1, 2023

Enrollment Period

5.6 years

First QC Date

October 22, 2018

Last Update Submit

June 24, 2023

Conditions

Hematopoietic Stem Cell TransplantationHaplo-identical DonorCord Blood UnitAcute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    estimated overall survival at 3 year

    3 year after randomization

Secondary Outcomes (3)

  • Progression-free survival

    3 year after randomization

  • Cumulative incidence of relapse

    3 year after randomization

  • Cumulative incidence of non-relapse mortality

    3 year after randomization

Study Arms (2)

Haplo-HCT

ACTIVE COMPARATOR

people enrolled in this arm will receive a typical haploidentical donor HCT

Procedure: haplo-HCT

Haplo-cord HCT

EXPERIMENTAL

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

Interventions

haplo-HCTPROCEDURE

HCT will be performed with a haploidentical donor

Haplo-HCT
haplo-cord HCTPROCEDURE

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

Haplo-cord HCT

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

The Second People's Hospital of Huai'an

Huai'an, Jiangsu, 223000, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Soochow Hopes Hematology Hospital

Suzhou, Jiangsu, 215100, China

Location

Hygeia Suzhou Yongding Hospital

Suzhou, Jiangsu, 215200, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Related Publications (1)

  • Zhou B, Chen J, Liu T, Ye Y, Zhang Y, Ding Y, Liu H, Zhu M, Ma X, Li X, Zhao L, Lin Z, Huang H, Xu Y, Wu D. Haploidentical hematopoietic cell transplantation with or without an unrelated cord blood unit for adult acute myeloid leukemia: a multicenter, randomized, open-label, phase 3 trial. Signal Transduct Target Ther. 2024 May 6;9(1):108. doi: 10.1038/s41392-024-01820-5.

    PMID: 38705885DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Depei Wu, M.D., Ph.D.

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 25, 2018

Study Start

June 1, 2017

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

June 27, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(5)