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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2022-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DAC combined with unrelated cord blood transplantation

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.

Group Type EXPERIMENTAL

Unrelated cord blood

Intervention Type BIOLOGICAL

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

Interventions

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Unrelated cord blood

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

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.

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;

Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No