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The granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols have been widely used for graft-versus-host disease (GVHD) prophylaxis in haploidentical related donor transplantation (haplo-HSCT). Nevertheless, severe acute GVHD remains an obstacle for haplo-HSCT. This study is aim to evaluate the efficacy of a modified protocol that includes PTCY and ATG in recipients of haplo-HSCT.
Haploidentical related donor transplantation is now considered an important alternative to allogeneic hematopoietic stem cell transplantation (allo-HSCT). Currently, the strategies for graft-versus-host disease (GVHD) prophylaxis mainly include ex vivo and in vivo T-cell depletion (TCD) in haploidentical HSCT (haplo-HSCT). In vivo TCD modalities have become mainstream including granulocyte colony-stimulating factor (G-CSF)+antithymocyte globulin (ATG)-based protocols and posttransplantation cyclophosphamide (PTCy) protocols. The ATG strategy has been widely used. Nevertheless, severe acute GVHD remains an obstacle for haplo-HSCT. In addition, infections, especially viral infections, remain an important drawback of this strategy. This study is aim to evaluate the efficacy of a modified protocol that includes PTCY and ATG in recipients of haplo-HSCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PTCy-ATG group | Active Comparator | PTCy-ATG group refers to treatment with PTCy-ATG protocol as GVHD prophylaxis at a total dose of 4.5mg/kg ATG, a dose of 50mg/kg/d cyclophosphamide (CTX), a dose of 2.5mg/kg/d Ciclosporin A （CsA）, and a dose of 1.0g/d Mycophenolate Mofetil(MMF). |
|
| ATG group | Active Comparator | ATG group refers to treatment with ATG protocol as GVHD prophylaxis at a total dose of 7.5mg/kg ATG, a dose of 2.5mg/kg/d Ciclosporin A （CsA）, a dose of 1.0g/d Mycophenolate Mofetil(MMF) and methotrexate (MTX, on days +1, +3 and +6). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATG | Drug | In PTCy-ATG group, ATG will be intravenously infused via a central venous catheter from day -3 until day -1 at a total dose of 4.5mg/kg. In ATG group, ATG will be intravenously infused via a central venous catheter from day -5 until day -2 at a total dose of 7.5mg/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| CMV DNAemia | CMV DNAemia was defined as positive CMV-DNA in the blood when the copies exceeded 500 copies/ml. | 1 year posttransplantation |
| Measure | Description | Time Frame |
|---|---|---|
| aGVHD | aGVHD (acute GVHD) was defined according to the 1994 Consensus Conference on Acute GVHD Grading and graded from I to IV. | 100 days 1 year posttransplantation |
| cGVHD | Chronic GVHD (cGVHD) was graded as limited or extensive. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ren Lin, M.D. | Contact | +86-020-62787883 | lansinglinren@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Qifa Liu | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology,Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24292519 | Background | Wang Y, Fu HX, Liu DH, Xu LP, Zhang XH, Chang YJ, Chen YH, Wang FR, Sun YQ, Tang FF, Liu KY, Huang XJ. Influence of two different doses of antithymocyte globulin in patients with standard-risk disease following haploidentical transplantation: a randomized trial. Bone Marrow Transplant. 2014 Mar;49(3):426-33. doi: 10.1038/bmt.2013.191. Epub 2013 Dec 2. | |
| 24566712 |
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|
| CTX | Drug | In PTCy-ATG group, CTX will be intravenously infused via a central venous catheter on day +4 at a dose of 50mg/kg/d. |
|
| Mycophenolate Mofetil | Drug | In PTCy-ATG group, Mycophenolate Mofetil will be taken orally from day +5 with the dosage of 0.5g twice a day. The dosage will be halved from day +30. In ATG group, Mycophenolate Mofetil will be taken orally from day -9 with the dosage of 0.5g twice a day. The dosage will be halved from day +30. |
|
| Ciclosporin A (CsA) | Drug | In PTCy-ATG group, Ciclosporin A (CsA) will be intravenously infused from day +5 at a dose of 2.5mg/kg/d. In ATG group, Ciclosporin A (CsA) will be intravenously infused from day -9 at a dose of 2.5mg/kg/d. |
|
| methotrexate (MTX) | Drug | In ATG group, methotrexate (MTX) will be intravenously on days +1, +3 and +6. |
|
| 2 year posttransplantation |
| EBV DNAemia | EBV DNAemia was defined as positive EBV-DNA in the blood when the copies exceeded 500 copies/ml. | 1 year posttransplantation |
| Leukemia relapse | primary disease relapse | 2 year posttransplantation |
| OS | overall survival | 2 year posttransplantation |
| DFS | disease-free survival | 2 year posttransplantation |
| Guangzhou First People's Hospital | Not yet recruiting | Guangzhou | Guangdong | China |
|
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Not yet recruiting | Guangzhou | Guangdong | China |
|
| The Third Affiliated Hospital, Sun Yat-Sen University | Not yet recruiting | Guangzhou | Guangdong | China |
|
| Xiangya Hospital, Central South University | Not yet recruiting | Changsha | Hunan | China |
|
| Chenzhou First People's Hospital | Not yet recruiting | Chenzhou | Hunan | China |
|
| Peking University People's Hospital | Not yet recruiting | Beijing | China |
|
| Chang YJ, Huang XJ. Haploidentical SCT: the mechanisms underlying the crossing of HLA barriers. Bone Marrow Transplant. 2014 Jul;49(7):873-9. doi: 10.1038/bmt.2014.19. Epub 2014 Feb 24. |
| 27927772 | Background | Baron F, Mohty M, Blaise D, Socie G, Labopin M, Esteve J, Ciceri F, Giebel S, Gorin NC, Savani BN, Schmid C, Nagler A. Anti-thymocyte globulin as graft-versus-host disease prevention in the setting of allogeneic peripheral blood stem cell transplantation: a review from the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation. Haematologica. 2017 Feb;102(2):224-234. doi: 10.3324/haematol.2016.148510. Epub 2016 Dec 7. |
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007239 | Infections |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D003524 | Cyclosporins |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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