Decitabine Combined With Unrelated Cord Blood Transplantation for Elderly Patients With AML

Summary

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.

Conditions

• Acute Myeloid Leukemia

Interventions

BIOLOGICAL

Unrelated cord blood

Unrelated cord blood comes from Shandong cord blood bank. TNC\>1.5\*107/kg;HLA 4-5/6

Sponsors & Collaborators

• Navy General Hospital, Beijing

  collaborator OTHER

• Beijing Jishuitan Hospital

  collaborator OTHER

• The Affiliated Hospital of Xuzhou Medical University

  collaborator OTHER

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• Luoyang Central Hospital

  collaborator OTHER

• People's Hospital of Zhengzhou University

  collaborator OTHER

• Dongguan People's Hospital

  collaborator OTHER_GOV

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Taian City Central Hospital

  collaborator OTHER

• Qilu Hospital of Shandong University (Qingdao)

  collaborator OTHER

• Ruijin Hospital

  lead OTHER

Principal Investigators

• Junmin Li · Ruijin Hospital Affiliated to Shanghai Jiaotong University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

60 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-09-01

Primary Completion

2019-12-31

Completion

2022-09-30

Countries

• China

Study Locations