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

Primary Purpose

Acute Myeloid Leukemia

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Unrelated cord blood
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring AML,Elderly patients,Decitabine,Unrelated cord blood

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DAC combined with unrelated cord blood transplantation

Arm Description

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.

Outcomes

Primary Outcome Measures

Disease free survival (DFS)

Secondary Outcome Measures

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

Full Information

First Posted
April 11, 2019
Last Updated
July 21, 2019
Sponsor
Ruijin Hospital
Collaborators
Navy General Hospital, Beijing, Beijing Jishuitan Hospital, The Affiliated Hospital of Xuzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Luoyang Central Hospital, People's Hospital of Zhengzhou University, Dongguan People's Hospital, The First Affiliated Hospital of Xiamen University, Taian City Central Hospital, Qilu Hospital of Shandong University (Qingdao)
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1. Study Identification

Unique Protocol Identification Number
NCT03913312
Brief Title
Decitabine Combined With Unrelated Cord Blood Transplantation for Elderly Patients With AML
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
Collaborators
Navy General Hospital, Beijing, Beijing Jishuitan Hospital, The Affiliated Hospital of Xuzhou Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Luoyang Central Hospital, People's Hospital of Zhengzhou University, Dongguan People's Hospital, The First Affiliated Hospital of Xiamen University, Taian City Central Hospital, Qilu Hospital of Shandong University (Qingdao)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
AML,Elderly patients,Decitabine,Unrelated cord blood

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DAC combined with unrelated cord blood transplantation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Unrelated cord blood
Intervention Description
Unrelated cord blood comes from Shandong cord blood bank. TNC>1.5*107/kg;HLA 4-5/6
Primary Outcome Measure Information:
Title
Disease free survival (DFS)
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
The time from enrollment to death for any reason
Time Frame
Three years
Title
Complete Remission Rate (CR)
Description
The proportion of cases of hematologic remission that reached the total
Time Frame
Three years
Title
Adverse Events (refer to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 4.03).
Description
Safety/Toxicity Monitoring
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junmin Li
Phone
86-21-64374756
Email
drlijunmin@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junmin Li
Organizational Affiliation
Ruijin Hospital Affiliated to Shanghai Jiaotong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junmin Li, M.D.
Email
drlijunmin@126.com

12. IPD Sharing Statement

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

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