Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Haplo-HSCT group | Experimental | 58 patients will be involved in this group |
|
| Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation group | Experimental | 58 patients will be involved in this group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined haploidentical and umbilical cord blood allogeneic stem cell transplantation | Procedure | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Defined as the survival duration starting at the day of transplantation, terminating at the day of death or the end of follow-up | 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 | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative relapse incidence | Defined as the cumulative incidence of relapse after the day of transplantation | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aiming Pang | Contact | +86-13820398091 | pangaiming@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Erlie Jiang | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | 300041 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| haploidentical hematopoietic stem cell transplantation | Procedure | Receive haploidentical hematopoietic stem cell transplantation (HLA 6-10/10) |
|
| 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 | 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) | 12 months |
| Cumulative Incidence of Infectious Complications | Defined as cumulative incidence of viral, fungal and bacterial infections | 12 months |
| Cumulative Incidence of hemorrhagic cystitis | Defined as the cumulative incidence of hemorrhagic cystitis after the day of transplantation | 12 months |
| Cumulative Incidence of lymphoproliferative disease | Defined as the cumulative incidence of lymphoproliferative disease after the day of transplantation | 12 months |