Allogeneic stem cell transplantation (Allo-HSCT) is the effective and even the only treatment option for acute leukemia. The haplo-hematopoietic stem cell transplantation(haplo-HSCT) and "GIAC" protocol have crossed HLA barrier and helped more patients find donors. However, the engraftment failure and incidence of graft-versus-host disease(GVHD) limit the prognosis of patients who receive the haplo-HSCT. It is believed that Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation improved hematopoietic reconstitution and reduced the incidence of GVHD, there is still no consensus about the efficacy and safety of this kind of therapy. This prospective, randomized and controlled study is to investigate the efficacy and safety of Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation
This prospective, randomized and controlled study is to investigate the efficacy and safety of Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation. Investigators will recruit 116 patients with acute leukemia, with 58 of them entering the haplo-HSCT group and receiving haploidentical hematopoietic stem cell transplantation, while the other 58 entering the combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group and receiving haploidentical and umbilical cord blood allogeneic stem cell transplantation at the same day. Then primary outcomes including overall survival and disease free survival, as well secondary outcomes such as cumulative relapse incidence and cumulative incidence of engraftment will be measured during 12 months after the intervention being finished.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Patients will receive umbilical cord blood allogeneic stem cell transplantation at the same day as the haploidentical stem cell transplantation. (HLA 6-10/10, TNC≥1-3×10-7/Kg)
Receive haploidentical hematopoietic stem cell transplantation (HLA 6-10/10)
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITINGOverall survival
Defined as the survival duration starting at the day of transplantation, terminating at the day of death or the end of follow-up
Time frame: 12 months
Disease free survival
Defined as the time starting at the day of transplantation, terminating at the day when the sign of AL is found or the end of follow-up
Time frame: 12 months
Cumulative relapse incidence
Defined as the cumulative incidence of relapse after the day of transplantation
Time frame: 12 months
Cumulative incidence of engraftment
Neutrophil recovery was defined as an absolute neutrophil count(ANC) of 0.5×10\^9/L or more for three consecutive days , while platelet recovery difined as 20×10\^9/L or more for seven consecutive days without transfusion
Time frame: 12 months
cumulative incidence of acute graft-versus-host disease(GVHD)
Acute graft versus host disease will be diagnosed and graded by modified Glucksberg criteria
Time frame: 12 months
cumulative incidence of chronic GVHD at one year
chronic graft versus host disease will be diagnosed and graded by National Institute of Health Consensus (NIH Consensus)
Time frame: 12 months
Cumulative Incidence of Infectious Complications
Defined as cumulative incidence of viral, fungal and bacterial infections
Time frame: 12 months
Cumulative Incidence of hemorrhagic cystitis
Defined as the cumulative incidence of hemorrhagic cystitis after the day of transplantation
Time frame: 12 months
Cumulative Incidence of lymphoproliferative disease
Defined as the cumulative incidence of lymphoproliferative disease after the day of transplantation
Time frame: 12 months
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