NCT05634915

Brief Summary

The purpose of this prospective, open-label, pairing design, single-center study is to evaluate the effect of individualized rATG dosing vs traditional weight-based rATG dosing regimen（10mg/kg）for patients with acute leukemia undergoing a myeloablative conditioning regimen and haploidentical hematopoietic stem cell transplantation (haplo-HSCT).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2022

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

November 22, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 2, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

December 20, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 15, 2023

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

November 22, 2022

Last Update Submit

February 13, 2023

Conditions

Hematopoietic Stem Cell TransplantationAcute Leukemia

Keywords

Antithymocyte GlobulinPopulation pharmacokinetic modelHaploidentical Hematopoietic Stem Cell TransplantationAcute Leukemia

Outcome Measures

Primary Outcomes (3)

  • Cumulative incidences of aGVHD

    The diagnosis and grading of aGVHD are based on the modified Glucksberg grading standard.

    100 days after transplantation

  • CD4+ immune reconstitution

    CD4+ T-cells \>0·05 × 10⁹/L twice within 3 months after transplantation

    3 months after transplantation

  • Leukemia-free survival (LFS)

    Leukemia-free survival (LFS) is defined as the time from enrollment to relapse of primary disease or death from any cause, whichever occurred first.

    1 years after transplantation

Secondary Outcomes (9)

  • Cumulative incidences of cGVHD

    1 years after transplantation

  • Cumulative incidences of EBV reactivation

    1 years after transplantation

  • Cumulative incidence of CMV reactivation

    1 years after transplantation

  • Neutrophil engraftment

    1 month after transplantation

  • Platelet engraftment

    1 month after transplantation

  • +4 more secondary outcomes

Study Arms (2)

Individual dose of ATG

EXPERIMENTAL

The total individual ATG dose was calculated based on population pharmacokinetic modeling. ATG was intravenously infused every day from day -5 to day -2.

Drug: Individual ATG

ATG 10mg/kg

ACTIVE COMPARATOR

The total ATG dose was 10mg/kg. ATG was intravenously infused every day from day -5 to day -2.

Drug: ATG

Interventions

Individual ATGDRUG

Individual dose of ATG: Individual dose of ATG was Intravenous infused every day from day -5 to day -2 (total ATG dose was calculated based on population pharmacokinetic modeling). Prophylaxis against graft-versus-host disease (GVHD) was performed with cyclosporine A, mycophenolate mofetil, and low-dose methotrexate.

Individual dose of ATG
ATGDRUG

ATG 10mg/kg: The total ATG dose was 10mg/kg. ATG was intravenously infused every day from day -5 to day -2. Prophylaxis against graft-versus-host disease (GVHD) was performed with cyclosporine A, mycophenolate mofetil, and low-dose methotrexate.

ATG 10mg/kg

Eligibility Criteria

Age16 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • All patients were diagnosed with acute leukemia.
  • All patients should have the indication of Haploidentical hematopoietic stem cell transplant and receive the myeloablative conditioning regimen.
  • All patients should sign an informed consent document indicating that they understand the purpose of and procedures required for the study and be willing to participate in the study.

You may not qualify if:

  • Patients with any conditions not suitable for the trial (investigators' decision).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

RECRUITING

Study Officials

  • Xiaowen Tang, PhD

    The First Affiliated Hospital of Soochow University

    STUDY CHAIR

Central Study Contacts

Xiaowen Tang, PhD

CONTACT

67781525xwtang1020@163.com

Depei Wu, PhD

CONTACT

67781856drwudepei@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2022

First Posted

December 2, 2022

Study Start

December 20, 2022

Primary Completion

December 1, 2024

Study Completion

May 1, 2025

Last Updated

February 15, 2023

Record last verified: 2022-11

Locations

CN(1)