Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Navy General Hospital, Beijing | OTHER |
| Beijing Jishuitan Hospital | OTHER |
| The Affiliated Hospital of Xuzhou Medical University | OTHER |
| Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
Not provided
Not provided
Not provided
Not provided
Not provided
Acute myeloid leukemia (AML) is a clonal disease caused by genetic mutations in Hematopoietic stem progenitor cells. Unfortunately, advanced age (>60 years old) is considered to be one of the most important adverse prognostic factors for AML, and older patients are unable to tolerate high-dose chemotherapy, due to various complications and organ dysfunction. Based on the results of the previous research, we will carry out the pretreatment regimen of decitabine + cytarabine in elderly patients with AML who have achieved disease treatment through induction therapy, and continue the transplantation program of unrelated-blood cord blood. By assessing the patient's DFS,OS,RFS and safety to determine whether the regimen is suitable for the consolidation treatment of elderly acute myeloid leukemia, further clarify the efficacy of this regimen compared with traditional consolidation therapy, and initially confirm the effect of combined with unrelated cord blood transplantation in the treatment of acute myeloid leukemia.
A prospective,Multicenter,open,single-arm clinical study.The research process is divided into three phases: the screening phase, the treatment phase, and the follow-up phase. The treatment phase includes pre-transplant pretreatment, cord blood transplantation, and consolidation therapy.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAC combined with unrelated cord blood transplantation | Experimental | Decitabine (DAC) 15mg/m2/d, d-7 to d-3;Ara-C 1000g/m2/q12h, d-2 to d-1.Single unrelated cord blood (TNC>1.5*107/kg), d0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Unrelated cord blood | Biological | Unrelated cord blood comes from Shandong cord blood bank. TNC>1.5*107/kg;HLA 4-5/6 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) | Three years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | The time from enrollment to death for any reason | Three years |
| Complete Remission Rate (CR) | The proportion of cases of hematologic remission that reached the total |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junmin Li | Contact | 86-21-64374756 | drlijunmin@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Junmin Li | Ruijin Hospital Affiliated to Shanghai Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
Not provided
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| OTHER |
| Luoyang Central Hospital | OTHER |
| People's Hospital of Zhengzhou University | OTHER |
| Dongguan People's Hospital | OTHER_GOV |
| The First Affiliated Hospital of Xiamen University | OTHER |
| Taian City Central Hospital | OTHER |
| Qilu Hospital of Shandong University (Qingdao) | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Three years |
| Adverse Events (refer to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03). | Safety/Toxicity Monitoring | Three years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |