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

July 21, 2019 updated by: Li Junmin, Ruijin Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Unrelated cord blood
Unrelated cord blood comes from Shandong cord blood bank. TNC>1.5*107/kg;HLA 4-5/6

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease free survival (DFS)
Time Frame: Three years
Three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Three years
The time from enrollment to death for any reason
Three years
Complete Remission Rate (CR)
Time Frame: Three years
The proportion of cases of hematologic remission that reached the total
Three years
Adverse Events (refer to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03).
Time Frame: Three years
Safety/Toxicity Monitoring
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Collaborators

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Dongguan People's Hospital
Beijing Jishuitan Hospital
Navy General Hospital, Beijing
The Affiliated Hospital of Xuzhou Medical University
The First Affiliated Hospital of Xiamen University
Luoyang Central Hospital
Taian City Central Hospital
Qilu Hospital of Shandong University (Qingdao)
People's Hospital of Zhengzhou University

Investigators

  • Principal Investigator: Junmin Li, Ruijin Hospital affiliated to Shanghai Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

December 31, 2019

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 21, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJ-AML 2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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