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

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ClinicalTrials.gov Identifier: NCT03913312
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
Navy General Hospital of PLA
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)
Information provided by (Responsible Party):
Li Junmin, Ruijin Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Biological: Unrelated cord blood Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : September 30, 2022


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




Primary Outcome Measures :
  1. Disease free survival (DFS) [ Time Frame: Three years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Three years ]
    The time from enrollment to death for any reason

  2. Complete Remission Rate (CR) [ Time Frame: Three years ]
    The proportion of cases of hematologic remission that reached the total

  3. 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



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Ages Eligible for Study:   60 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913312


Contacts
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Contact: Junmin Li 86-21-64374756 drlijunmin@126.com

Locations
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China, Shanghai
Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Junmin Li, M.D.       drlijunmin@126.com   
Sponsors and Collaborators
Ruijin Hospital
Navy General Hospital of PLA
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)
Investigators
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Principal Investigator: Junmin Li Ruijin Hospital Affiliated to Shanghai Jiaotong University

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Responsible Party: Li Junmin, Director of the hematology department, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT03913312     History of Changes
Other Study ID Numbers: RJ-AML 2018
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Li Junmin, Ruijin Hospital:
AML,Elderly patients,Decitabine,Unrelated cord blood
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors