ATG Plus Low-dose PT-Cy for GVHD Prevention
- Registration Number
- NCT06108739
- Lead Sponsor
- Peking University People's Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 196
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ATG-PTCy cohort Cyclophosphamid 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. ATG-PTCy cohort ATG 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. ATG cohort ATG 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.
- Primary Outcome Measures
Name Time Method The incidence of acute graft versus host disease. 100 days post HSCT. The incidence of acute graft versus host disease. The severity of acute GVHD was evaluated according to standard international criteria.
- Secondary Outcome Measures
Name Time Method Engraftment 30 days post HSCT. Myeloid engraftment was defined as the first of three consecutive days with an ANC X0.5≥10\^9/L.
The incidence of chronic GvHD 1 year post HSCT. The incidence of chronic GvHD.
The incidence of non-relapse mortality 1 year post HSCT. The incidence of non-relapse mortality
The incidence of infection 1 year post HSCT. The incidence of infection
Overall survival 1 year post HSCT. Overall survival
The incidence of relapse 1 year post HSCT. The incidence of relapse
Immune reconstitution 1 year post HSCT. 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.
Disease free survival 1 year post HSCT. Disease free survival
GvHD relapse free survival 1 year post HSCT. GvHD relapse free survival
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, China