A Phase 3 interventional study of Cyclophosphamid and ATG in Hematologic Malignancy, sponsored by Peking University People's Hospital. Terminated at 1 site in China. Open to participants aged 12 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by Peking University People's Hospital · Phase 3, Interventional, and Treatment
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.
1,464 studies on the registry are indexed under Hematologic Neoplasms; 433 are open to participants now.
This study's enrollment of 66 is above the median of 45 across 1,068 interventional studies indexed under Hematologic Neoplasms.
Browse Hematologic Neoplasms studies →Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.
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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
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
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.
A total of 10mg/kg ATG was administered.
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.
Time frame: 100 days post HSCT.
Engraftment
Myeloid engraftment was defined as the first of three consecutive days with an ANC X0.5≥10\^9/L.
Time frame: 30 days post HSCT.
The incidence of chronic GvHD
The incidence of chronic GvHD.
Time frame: 1 year post HSCT.
The incidence of non-relapse mortality
The incidence of non-relapse mortality
Time frame: 1 year post HSCT.
The incidence of infection
The incidence of infection
Time frame: 1 year post HSCT.
The incidence of relapse
The incidence of relapse
Time frame: 1 year post HSCT.
Overall survival
Overall survival
Time frame: 1 year post HSCT.
Disease free survival
Disease free survival
Time frame: 1 year post HSCT.
GvHD relapse free survival
GvHD relapse free survival
Time frame: 1 year post HSCT.
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.
Time frame: 1 year post HSCT.
This study is terminated, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital