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DSMB recommended halting the study owing to futility after the first interim analysis in August 2024.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment | Myeloid engraftment was defined as the first of three consecutive days with an ANC X0.5≥10^9/L. | 30 days post HSCT. |
| The incidence of chronic GvHD | The incidence of chronic GvHD. |
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Inclusion Criteria:
1) Cardiac ejection index >55% 2) Creatinine ≤1.5 times the highest normal value (ULN)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40534493 | Derived | 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. |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| ATG | Drug | A total of 10mg/kg ATG was administered. |
|
| 1 year post HSCT. |
| The incidence of non-relapse mortality | The incidence of non-relapse mortality | 1 year post HSCT. |
| The incidence of infection | The incidence of infection | 1 year post HSCT. |
| The incidence of relapse | The incidence of relapse | 1 year post HSCT. |
| Overall survival | Overall survival | 1 year post HSCT. |
| Disease free survival | Disease free survival | 1 year post HSCT. |
| GvHD relapse free survival | GvHD relapse free survival | 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. | 1 year post HSCT. |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |