Hematopoietic Stem Cell Transplantation
Conditions
Keywords
Hematopoietic Stem Cell Transplantation, posttransplantation cyclophosphamide, antithymocyte globulin, viral infection, graft-versus-host disease
Brief summary
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.
Detailed description
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.
Interventions
DRUGATG
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.
DRUGCTX
In PTCy-ATG group, CTX will be intravenously infused via a central venous catheter on day +4 at a dose of 50mg/kg/d.
DRUGMycophenolate Mofetil
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.
DRUGCiclosporin A (CsA)
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.
DRUGmethotrexate (MTX)
In ATG group, methotrexate (MTX) will be intravenously on days +1, +3 and +6.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A patient age of 18-65 years * Haploidentical hematopoietic stem cell transplant recipient * Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion criteria
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CMV DNAemia | 1 year posttransplantation | CMV DNAemia was defined as positive CMV-DNA in the blood when the copies exceeded 500 copies/ml. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cGVHD | 2 year posttransplantation | Chronic GVHD (cGVHD) was graded as limited or extensive. |
| EBV DNAemia | 1 year posttransplantation | EBV DNAemia was defined as positive EBV-DNA in the blood when the copies exceeded 500 copies/ml. |
| aGVHD | 100 days 1 year posttransplantation | aGVHD (acute GVHD) was defined according to the 1994 Consensus Conference on Acute GVHD Grading and graded from I to IV. |
| OS | 2 year posttransplantation | overall survival |
| DFS | 2 year posttransplantation | disease-free survival |
| Leukemia relapse | 2 year posttransplantation | primary disease relapse |
Countries
China
Contacts
Primary ContactRen Lin, M.D.
Outcome results
None listed