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In this phase clinical trail, we evaluate the efficacy and feasibility of azacytidine and venetoclax as leukemia debulking treatment followed by reduced intensity conditioning regimen consisting of Fludarabine + Busulfan + Melphalan as salvage treatment in patients with refractory AML .
In refractory AML, allogeneic hematopoietic stem cell transplantation (allo-HCST) is considered as the only curative regimen. In this phase II clinical trial, we plan to evaluate the efficacy and feasibility of new sequential transplantation protocol. All patients receive azacytidine and venetoclax as leukemia debulking treatment which is followed by reduced intensity conditioning regimen consisting of Fludarabine (150mg/m2) + Busulfan (6.4mg/kg) + Melphalan (70mg/m2). The graft-versus host disease (GVHD) prophylaxis regimen is based on reduced dose of post-transplantation cyclophosphamide (PT-CY) 40mg/kg day+3~+4, tacrolimus and low-dose anti-thymoglobulin (ATG, 2.5mg/kg) in case of HLA-matched unrelated donor or halo-donor transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aza-ven +MBF | Experimental | treatment with aza-ven debulking therapy followed by allo-HSCT with MBF conditioning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aza-Ven-allo-HSCT | Drug | aaa-ven treatment followed by allo-HCTS with reduced toxicity conditioning (RTC) of Fludarabine, Busulifan and Melphalan |
|
| Measure | Description | Time Frame |
|---|---|---|
| relapse-free survival | event defined as relapse or death of any causes | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | event defined as death of all causes | 12 months |
| non-relapse mortality | event defined as death of all causes other than leukemia relapse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiong HU | Contact | 86-21-64370045 | 601878 | hj10709@rjh.com.cn |
| Jie-ling Jiang | Contact | 86-21-64370045 | 601878 | jiangjieling66@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiong HU | Shanghai Rui Jin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blood & Marrow Transplantation Center, RuiJin Hospital | Recruiting | Shanghai | 200025 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 12 months |
| relapse | event defined as leukemia relapse | 12 months |
| GVHD and relapse free survival (GRFS) | event defined as leukemia relapse, death of any causes, III-IV aGVHD or moderate to severe cGVHD | 12 months |
| Department of Hematology, Shanghai No6 Hospital | Recruiting | Shanghai | China |
|
| Shanghai ZhaXin Hospital | Recruiting | Shanghai | China |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |