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Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. We previously reported encouraging results with a novel Flu/Cy regimen. However, there are still around 20% patients developed delayed platelet recovery. We designed a modified regimen to further improve the hematopoietic reconstitution after second transplantation. This prospective, single-arm study aims to investigate the safety and efficacy of this modified regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intervention arm | Experimental | second haploidentical stem cell transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| second allogeneic stem cell transplantation | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment of neutrophils | Engraftment of neutrophils was defined as the first of 3 consecutive days when the absolute neutrophil count achieved 500/uL. | 28 days after second transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment of Platelet | Platelet engraftment was defined as the first of 7 consecutive days that platelet counts ≥20 × 10^9/L in the absence of platelet transfusion | 100 days after second transplantation |
| TRM at 28 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu-qian Sun, M.D. | Contact | +86-10-88324577 | sunyuqian83@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiao-Jun Huang, M.D. | Institute of Hematology, Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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|
treatment-related mortality(TRM) was defined as death from any cause other than relapse.
| 28 days after second transplantation |
| TRM at 100 day | treatment-related mortality (TRM) was defined as death from any cause other than relapse | 100 days after second transplantation |
| GVHD | Both acute and chronic GVHD was diagnosed and graded according to international criteria. | Participants will be followed for an expected average of 1 year |
| OS | Overall survival (OS) | Participants will be followed for an expected average of 1 year |
| LFS | Leukemia-free survival (LFS) was defined as the survival period with continuous CR. | Participants will be followed for an expected average of 1 year |
| CIR | The cumulative incidence of relapse (CIR) | Participants will be followed for an expected average of 1 year |