ATG Plus Low-dose PT-Cy for GVHD Prevention

NCT06108739 | Terminated Phase 3

• 1 other identifier: ATG plus PT-Cy in haplo-SCT
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

During the past decades, the wider application of easily available haploidentical donor hematopoietic cell transplant (haplo-HCT) has been made possible through the T cell-replete (TCR) regimens including T cell regulation with anti-thymocyte globulin (ATG)/granulocyte colony-stimulating factor (GCSF) and post-transplant cyclophosphamide (PTCy). To achieve decreased non-relapse mortality (NRM) and improved long-term outcomes in haploidentical transplant, the joint use of ATG and PTCy might effectively reduce graft versus host disease (GVHD) and mortality associated with severe forms of GVHD. Recently, investigators established a regimen using low-dose PTCy in conjunction with standard-dose ATG in order to lower the risk of GVHD without compromising engraftment and disease relapse.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• The incidence of acute graft versus host disease.

  The incidence of acute graft versus host disease. The severity of acute GVHD was evaluated according to standard international criteria.

  100 days post HSCT.

Secondary Outcomes (9)

• Engraftment

  30 days post HSCT.

• The incidence of chronic GvHD

  1 year post HSCT.

• The incidence of non-relapse mortality

  1 year post HSCT.

• The incidence of infection

  1 year post HSCT.

• The incidence of relapse

  1 year post HSCT.

Study Arms (2)

ATG-PTCy cohort

EXPERIMENTAL

The conditioning regimen is ATG/G-CSF based protocol (the so-called Beijing protocol). The rabbit ATG (Sangstat-Genzyme) 2.5mg/kg/day i.v., on days from - 5 to - 2 were administered.Two doses of 14.5 mg/kg Cy were given on days 3 and 4 post-HCT in ATG-PTCy cohort.

Drug: Cyclophosphamid; Drug: ATG

ATG cohort

ACTIVE COMPARATOR

The conditioning regimen is ATG/G-CSF based protocol (the so-called Beijing protocol). The rabbit ATG (Sangstat-Genzyme) 2.5mg/kg/day i.v., on days from - 5 to - 2 were administered.

Drug: ATG

Interventions

Cyclophosphamid DRUG

A total of 10mg/kg ATG was administered, and two doses of 14.5 mg/kg Cy were given on days 3 and 4 post-HCT in ATG-PTCy cohort.

ATG-PTCy cohort

ATG DRUG

A total of 10mg/kg ATG was administered.

ATG cohort; ATG-PTCy cohort

Eligibility Criteria

• Age: 12 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with acute leukemia and/or myelodysplastic syndrome undergoing their first allogeneic hematopoietic stem cell transplantation;
• Male or female , aged 12-55 years;
• Haploidentical donor transplantation;
• ECOG score ≤3; The basic organ function tests met the following standards;
• \) Cardiac ejection index \>55% 2) Creatinine ≤1.5 times the highest normal value (ULN)

You may not qualify if:

• Severe brain, heart, kidney or liver dysfunction;
• Refractory malignant state;
• Patients with other malignant tumors requiring treatment;
• Clinically uncontrolled severe active infection;
• The expected survival time was less than 3 months.
• A history of severe anaphylaxis.
• Pregnant or lactating women;
• Any condition considered by the investigators to be unsuitable for enrollment.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, China

Location

Related Publications (1)

• Xu ZL, Han TT, Zhu XL, Liu J, Lv M, Sun YQ, Mo XD, Cheng YF, Xu LP, Zhang XH, Huang XJ, Wang Y. Randomized trial of anti-thymocyte globulin plus lowdose post-transplant cyclophosphamide to prevent graft-versus- host disease in haploidentical transplantation. Haematologica. 2025 Dec 1;110(12):2965-2973. doi: 10.3324/haematol.2025.287504. Epub 2025 Jun 19.

  PMID: 40534493 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

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: Professor

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 31, 2023
• Study Start: November 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 3, 2025

Record last verified: 2024-08

Locations

CN (1)