ATG Plus Low-dose PT-Cy for GVHD Prevention

Hematologic Malignancy Clinical Trial

Official title:

Randomized Trial of Anti-thymocyte Globulin Plus Low-dose Post-transplant Cyclophosphamide for GVHD Prevention in Haploidentical Donor HCT

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06108739
• Other study ID #: ATG plus PT-Cy in haplo-SCT
• Status: Recruiting
• Phase: Phase 3
• Start date: November 1, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Peking University People's Hospital
• Contact: Yu Wang, M.D.
• Phone: 86-13552647384
• Email: ywyw3172[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms

Intervention

Drug:
• 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.
• ATG
A total of 10mg/kg ATG was administered.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Engraftment	Myeloid engraftment was defined as the first of three consecutive days with an ANC X0.5=10^9/L.	30 days post HSCT.
Secondary	The incidence of chronic GvHD	The incidence of chronic GvHD.	1 year post HSCT.
Secondary	The incidence of non-relapse mortality	The incidence of non-relapse mortality	1 year post HSCT.
Secondary	The incidence of infection	The incidence of infection	1 year post HSCT.
Secondary	The incidence of relapse	The incidence of relapse	1 year post HSCT.
Secondary	Overall survival	Overall survival	1 year post HSCT.
Secondary	Disease free survival	Disease free survival	1 year post HSCT.
Secondary	GvHD relapse free survival	GvHD relapse free survival	1 year post HSCT.
Secondary	Immune reconstitution	Immune reconstitution was evaluated at 1, 2, 3, 6, 9 and 12 months by analysis of peripheral blood MNCs detecting CD3, CD4, CD19 and immunoglobulin (Ig) A, G and M levels.	1 year post HSCT.