Trials Sponsors Conditions Drugs Pricing

Conditions

Haploidentical Hematopoietic Stem Cell Transplantation

Keywords

ATGHaplo-HSCT

Outcome Measures

Primary Outcomes (1)

GVHD-free and relapse-free survival (GRFS)
GRFS is defined as a composite endpoint of death from any cause, disease relapse, grade III-IV acute GVHD, or moderate to severe chronic GVHD requiring systemic immunosuppression therapy.
12 months after transplantation

Secondary Outcomes (12)

Cumulative incidences of CMV reactivation
6 months after transplantation
Incidence of CMV disease
6 months after transplantation
Cumulative incidences of EBV reactivation
6 months after transplantation
Cumulative incidences of PTLD(posttransplant lymphoproliferative disorders)
6 months after transplantation
Cumulative incidences of aGVHD
365 days after transplantation
+7 more secondary outcomes

Study Arms (2)

Individual dose of ATG

EXPERIMENTAL

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 pharmacokinetic index, within a range of 6 mg/kg to 13mg/kg), and the active ATG concentration ranges from 110 to 148.5UE/ml.

Drug: Individual Antithymocyte globulin

Fixed dose of ATG

ACTIVE COMPARATOR

A total amount of 10mg/kg ATG was divided into 4 days (from day -5 to day -2). The specific usage: 1.5mg/kg for day -5, 2.5mg/kg for day -4 and day -3, 3.5 mg/kg for day -2.

Drug: Antithymocyte globulin

Interventions

Individual Antithymocyte globulinDrug

Individual dose of ATG was Intravenous infused every day from day -5 to day -2 (total ATG dose was calculated based on pharmacokinetic index, within a range of 6 mg/kg to 13mg/kg). Prophylaxis against graft versus-host disease (GVHD) was performed with cyclosporine A (CsA), mycophenolate mofetil (MMF) and short-term methotrexate.

Individual dose of ATG

Antithymocyte globulinDrug

A 10mg/kg total dose of antithymocyte globulin (ATG) was added to conditioning regimens for 4 days (from day -5 to day -2). Prophylaxis against graft versus-host disease (GVHD) was performed with cyclosporine A (CsA), mycophenolate mofetil (MMF) and short-term methotrexate.

Eligibility Criteria

Age14 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

\. All patients should have the indication of Haploidentical hematopoietic stem cell transplant.
\. 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.

Sponsors & Collaborators

Peking University People's Hospital
Othercollaborator
The First Affiliated Hospital of Zhengzhou University
Othercollaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Related Publications (1)

Dou L, Wang N, Zhang H, Yang J, Du J, Liu Q, Zhang X, Li F, Boelens JJ, Wang H, Cao W, Zhang X, Liu D. Therapeutic-drug-monitoring-based ATG Targeted Dosing Strategy in Unmanipulated Haploidentical Haematopoietic Stem Cell Transplantation: a randomized, multicenter, phase 3 clinical trial. Cancer Lett. 2026 Jul 27;658:218766. doi: 10.1016/j.canlet.2026.218766. Online ahead of print.
PMID: 42508748DERIVED

MeSH Terms

Interventions

Antilymphocyte Serum

Intervention Hierarchy (Ancestors)

Immune SeraAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsBiological ProductsComplex Mixtures

Study Officials

Daihong Liu, Doctor
Chinese PLA General Hospital
PRINCIPAL INVESTIGATOR

Enrollment

204 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 22, 2021

Study Start

January 1, 2022

Actual (reported)

Targeted Dose Study of ATG in Haploidentical Hematopoietic Stem Cell Transplantation

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Individual dose of ATG

Fixed dose of ATG

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (12)

Study Arms (2)

Individual dose of ATG

Fixed dose of ATG

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations