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

Acute Myeloid Leukemia Clinical Trial

Official title:

Multicenter, One-arm, Phase II Clinical Study of Decitabine Combined With Unrelated Cord Blood Transplantation for the Treatment of Acute Myeloid Leukemia (AML) in the Elderly

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03913312
• Other study ID #: RJ-AML 2018
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 1, 2018
• Est. completion date: September 30, 2022

Study information

• Verified date: July 2019
• Source: Ruijin Hospital
• Contact: Junmin Li
• Phone: 86-21-64374756
• Email: drlijunmin[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2022
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

1. AML patients diagnosed by bone marrow morphology and Immunology;

2. Exclusion of APL by Bone marrow morphology or molecular level;

3. A patient who has obtained bone marrow cytology remission after inductive treatment;

4. Aged from 60 to 75 years;

5. Liver and kidney function: blood bilirubin = 35µmol / L, AST or/ALT <2 times the upper limit of normal (ULN), serum creatinine;= 150µmol / L;

6. The function of Heart is normal;

7. Physical condition score 0-2 (ECOG score);

8. Get informed consent signed by patient or family member.

Exclusion Criteria:

1. APL patients, treatment-related AML;

2. Retreatment of patients;

3. Allergies to any of the drugs involved in the protocol;

4. There are obvious contraindications to chemotherapy drugs;

5. Liver and kidney function is obviously abnormal, exceeding the inclusion criteria;

6. Serious heart disease, including myocardial infarction, cardiac insufficiency;

7. Suffering from other organ malignant tumors at the same time ;

8. Active period of tuberculosis patients and HIV-positive patients;

9. Suffering from other blood system diseases at the same time;

10. Pregnancy or breastfeeding;

11. Cannot understand or follow the research plan;

12. A history of intolerance or allergies to similar drugs;

13. Patients under 60 years of age or over 75 years of age;

14. Participate in other clinical researchers at the same time;

15. There are other situations that hinder the conduct of the study.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (11)

Lead Sponsor	Collaborator
Ruijin Hospital	Beijing Jishuitan Hospital, Dongguan People's Hospital, Luoyang Central Hospital, Navy General Hospital of PLA, People's Hospital of Zhengzhou University, Qilu Hospital of Shandong University (Qingdao), Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Taian City Central Hospital, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival (DFS)		Three years
Secondary	Overall Survival (OS)	The time from enrollment to death for any reason	Three years
Secondary	Complete Remission Rate (CR)	The proportion of cases of hematologic remission that reached the total	Three years
Secondary	Adverse Events (refer to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03).	Safety/Toxicity Monitoring	Three years