Clinical trial NCT03913312: Decitabine Combined With Unrelated Cord Blood Transplantation for Elderly Patients With AML
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: AML,Elderly patients,Decitabine,Unrelated cord blood
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Navy General Hospital, Beijing
name: Beijing Jishuitan Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Luoyang Central Hospital
name: People's Hospital of Zhengzhou University
name: Dongguan People's Hospital
name: The First Affiliated Hospital of Xiamen University
name: Taian City Central Hospital
name: Qilu Hospital of Shandong University (Qingdao)
First posted: 2019-04-12
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Disease free survival (DFS)
timeFrame: Three years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Three years
measure: Complete Remission Rate (CR)
timeFrame: Three years
measure: Adverse Events (refer to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03).
timeFrame: Three years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ruijin Hospital Affiliated to Shanghai Jiaotong University
name: Junmin Li
role: PRINCIPAL_INVESTIGATOR
References: