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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute Myeloid Leukemia
- Sponsor
- Ruijin Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Disease free survival (DFS)
- Last Updated
- 6 years ago
Overview
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.
Investigators
Li Junmin
Director of the hematology department
Ruijin Hospital
Eligibility Criteria
Inclusion Criteria
- •AML patients diagnosed by bone marrow morphology and Immunology;
- •Exclusion of APL by Bone marrow morphology or molecular level;
- •A patient who has obtained bone marrow cytology remission after inductive treatment;
- •Aged from 60 to 75 years;
- •Liver and kidney function: blood bilirubin ≤ 35μmol / L, AST or/ALT \<2 times the upper limit of normal (ULN), serum creatinine;≤ 150μmol / L;
- •The function of Heart is normal;
- •Physical condition score 0-2 (ECOG score);
- •Get informed consent signed by patient or family member.
Exclusion Criteria
- •APL patients, treatment-related AML;
- •Retreatment of patients;
- •Allergies to any of the drugs involved in the protocol;
- •There are obvious contraindications to chemotherapy drugs;
- •Liver and kidney function is obviously abnormal, exceeding the inclusion criteria;
- •Serious heart disease, including myocardial infarction, cardiac insufficiency;
- •Suffering from other organ malignant tumors at the same time ;
- •Active period of tuberculosis patients and HIV-positive patients;
- •Suffering from other blood system diseases at the same time;
- •Pregnancy or breastfeeding;
Outcomes
Primary Outcomes
Disease free survival (DFS)
Time Frame: Three years
Secondary Outcomes
- Overall Survival (OS)(Three years)
- Complete Remission Rate (CR)(Three years)
- Adverse Events (refer to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03).(Three years)