ATG Plus Low-dose PT-Cy for GVHD Prevention

NCT ID: NCT06108739

Last Updated: 2025-06-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2024-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ATG-PTCy cohort

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.

Group Type: EXPERIMENTAL

Cyclophosphamid

Intervention Type: 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

Intervention Type: DRUG

A total of 10mg/kg ATG was administered.

ATG cohort

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.

Group Type: ACTIVE_COMPARATOR

ATG

Intervention Type: DRUG

A total of 10mg/kg ATG was administered.

Interventions

Cyclophosphamid

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.

Intervention Type: DRUG

ATG

A total of 10mg/kg ATG was administered.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients with acute leukemia and/or myelodysplastic syndrome undergoing their first allogeneic hematopoietic stem cell transplantation;

2. Male or female , aged 12-55 years;

3. Haploidentical donor transplantation;

4. ECOG score ≤3; The basic organ function tests met the following standards;

1) Cardiac ejection index >55% 2) Creatinine ≤1.5 times the highest normal value (ULN)

Exclusion Criteria

1. Severe brain, heart, kidney or liver dysfunction;

2. Refractory malignant state;

3. Patients with other malignant tumors requiring treatment;

4. Clinically uncontrolled severe active infection;

5. The expected survival time was less than 3 months.

6. A history of severe anaphylaxis.

7. Pregnant or lactating women;

8. Any condition considered by the investigators to be unsuitable for enrollment.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao-Jun Huang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Peking University People's Hospital

Beijing, , China

Countries

China

Other Identifiers

ATG plus PT-Cy in haplo-SCT

Identifier Type: -

Identifier Source: org_study_id