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Completed

NCT Number: NCT03719534

Haplo HCT vs Haplo-cord HCT for Patients With AML

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplantation Acute Myeloid Leukemia Cord Blood Unit Haplo-identical Donor Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

haplo-HCT

Procedure

HCT will be performed with a haploidentical donor

haplo-cord HCT

Procedure

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

Primary outcomes

  1. Overall survival

    Time frame: 3 year after randomization

    estimated overall survival at 3 year

Secondary outcomes

  1. Progression-free survival

    Time frame: 3 year after randomization

    estimated progression-free survival at 3 year

  2. Cumulative incidence of relapse

    Time frame: 3 year after randomization

    estimated cumulative incidence of nonrelapse mortality at 3 year

  3. Cumulative incidence of non-relapse mortality

    Time frame: 3 year after randomization

    estimated nonrelapse mortality at 3 year

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • Hygeia Suzhou Yongding Hospital
  • Soochow Hopes Hematology Hospital
  • The Second People's Hospital of Huai'an
  • Zhejiang University

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Oct 25, 2018
Registry last updated
Jun 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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