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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
260
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.
In PTCy-ATG group, CTX will be intravenously infused via a central venous catheter on day +4 at a dose of 50mg/kg/d.
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.
Department of Hematology,Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGGuangzhou First People's Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
CMV DNAemia
CMV DNAemia was defined as positive CMV-DNA in the blood when the copies exceeded 500 copies/ml.
Time frame: 1 year posttransplantation
aGVHD
aGVHD (acute GVHD) was defined according to the 1994 Consensus Conference on Acute GVHD Grading and graded from I to IV.
Time frame: 100 days 1 year posttransplantation
cGVHD
Chronic GVHD (cGVHD) was graded as limited or extensive.
Time frame: 2 year posttransplantation
EBV DNAemia
EBV DNAemia was defined as positive EBV-DNA in the blood when the copies exceeded 500 copies/ml.
Time frame: 1 year posttransplantation
Leukemia relapse
primary disease relapse
Time frame: 2 year posttransplantation
OS
overall survival
Time frame: 2 year posttransplantation
DFS
disease-free survival
Time frame: 2 year posttransplantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
In ATG group, methotrexate (MTX) will be intravenously on days +1, +3 and +6.
The Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGXiangya Hospital, Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGChenzhou First People's Hospital
Chenzhou, Hunan, China
NOT_YET_RECRUITINGPeking University People's Hospital
Beijing, China
NOT_YET_RECRUITING