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

  • STATUS
    Recruiting
  • days left to enroll
    44
  • participants needed
    150
  • sponsor
    Ruijin Hospital
Updated on 3 February 2022
remission
cytarabine
umbilical cord blood transplantation
decitabine
consolidation therapy
neoadjuvant therapy

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.

Details
Condition Acute Myeloid Leukemia
Treatment Unrelated cord blood
Clinical Study IdentifierNCT03913312
SponsorRuijin Hospital
Last Modified on3 February 2022

Eligibility

Yes No Not Sure

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 35mol / L, AST or/ALT <2 times the upper limit of normal (ULN), serum creatinine; 150mol / 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
Cannot understand or follow the research plan
A history of intolerance or allergies to similar drugs
Patients under 60 years of age or over 75 years of age
Participate in other clinical researchers at the same time
There are other situations that hinder the conduct of the study
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