NCT03913312

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2018

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1.3 years

First QC Date

April 11, 2019

Last Update Submit

July 21, 2019

Conditions

Acute Myeloid Leukemia

Keywords

AML,Elderly patients,Decitabine,Unrelated cord blood

Outcome Measures

Primary Outcomes (1)

  • Disease free survival (DFS)

    Three years

Secondary Outcomes (3)

  • 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

Study Arms (1)

DAC combined with unrelated cord blood transplantation

EXPERIMENTAL

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.

Biological: Unrelated cord blood

Interventions

Unrelated cord bloodBIOLOGICAL

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

DAC combined with unrelated cord blood transplantation

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Junmin Li

    Ruijin Hospital Affiliated to Shanghai Jiaotong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junmin Li

CONTACT

86-21-64374756drlijunmin@126.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the hematology department

Study Record Dates

First Submitted

April 11, 2019

First Posted

April 12, 2019

Study Start

September 1, 2018

Primary Completion

December 31, 2019

Study Completion

September 30, 2022

Last Updated

July 23, 2019

Record last verified: 2019-07

Locations

CN(1)