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Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02985372
Recruitment Status : Unknown
Verified November 2016 by Chunyan Ji, Shandong University.
Recruitment status was:  Enrolling by invitation
First Posted : December 7, 2016
Last Update Posted : December 7, 2016
Sponsor:
Collaborators:
Binzhou Medical University
Shengli Oilfield Central Hospital
Heze Municipal Hospital
Jinan Military Genaral Hospital
Jinan Central Hospital
Jining Medical University
Linyi People's Hospital
Qingdao University
People's Hospital of Rizhao
Shandong Provincial Qianfoshan Hospital
Qilu Hospital of Shandong University (Qingdao)
Taian City Central Hospital
Taishan Medical University Affiliated Hospital
Weihai Municipal Hospital
Weifang Medical University
Zibo First Hospital
Central Hospital of Zibo
Information provided by (Responsible Party):
Chunyan Ji, Shandong University

Brief Summary:
This prospective multicenter clinical study was designed to assess the efficacy and safety of decitabine in combination with low-dose cytarabine induction treatment for elderly patients with newly diagnosed acute myeloid leukemia (AML).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia, Adult Drug: Decitabine Drug: Cytarabine Phase 3

Detailed Description:

All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).

Hydroxyurea was permitted as rescue medication if white blood count (WBC) was >20×109/L and but was discontinued at least 24h before decitabine treatment.

Supportive care including blood product transfusions, G-CSF, antiemetic medications, antiviral and antifungal medications, or empiric antibiotics may be used at the clinical discretion of the investigator.

Curative effect was evaluated after two cycles:

  1. <5% blast in the marrow, enter into maintenance therapy (Group A)
  2. ≥5% blast in the marrow, continue induction therapy two cycles,

    ① <5% blast in the marrow, enter into maintenance therapy (Group B);

    ② ≥5% blast in the marrow, dropped out of the study (Group C)

  3. marrow blast decline <60%, dropped out of the study (Group C).

Maintenance therapy regimen:

  1. Ara-C 1g/m2/d iv drip d1-4 1 cycle
  2. DEC 15mg/m2/d iv drip d1-5 1 cycle
  3. Ara-C 1g/m2/d iv drip d1-4 1 cycle
  4. DEC 15mg/m2/d iv drip d1-5 1 cycle

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Decitabine in Combination With Low-dose Cytarabine as Inductive Treatment in Newly Diagnosed Elderly Patients With Acute Myeloid Leukemia
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Acute myeloid leukemia
All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
Drug: Decitabine
All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).

Drug: Cytarabine



Primary Outcome Measures :
  1. Overall response rate [ Time Frame: three years ]
  2. complete remission rate [ Time Frame: three years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: three years ]
  2. progression-free survival [ Time Frame: three years ]
  3. mortality rate [ Time Frame: three years ]
  4. recurrence rate [ Time Frame: three years ]


Information from the National Library of Medicine

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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. Patients with previously untreated non-M3 AML (diagnosed by the WHO2016 criteria).
  2. Age: ≥ 60 and ≤ 75 years.
  3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5x upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine < 2ULN.
  5. Without central nervous system symptoms.
  6. Willing to accept the follow-up.
  7. Normal heart function(EF>50%). The subjects volunteer to sign the informed consent.

Exclusion Criteria:

  1. With severe cardiac, renal or hepatic insufficiency.
  2. With other cancers requiring treatment.
  3. With other hematological diseases(e.g. Hemophilia, myelofibrosis, etc.).
  4. With severe infection or metabolic disease(including tuberculosis and pulmonary aspergillosis).
  5. Brain disorders or severe mental diseases which could limit compliance with study requirements.
  6. Major operation within 3 weeks.
  7. With HIV infection or AIDS-associated diseases.
  8. Any drug abuse, medical, mental or social situations which would affect the results.
  9. Hypersensitivity to cytarabine (not including drug fever or exanthema) or decitabine.

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): NCT02985372


Sponsors and Collaborators
Chunyan Ji
Binzhou Medical University
Shengli Oilfield Central Hospital
Heze Municipal Hospital
Jinan Military Genaral Hospital
Jinan Central Hospital
Jining Medical University
Linyi People's Hospital
Qingdao University
People's Hospital of Rizhao
Shandong Provincial Qianfoshan Hospital
Qilu Hospital of Shandong University (Qingdao)
Taian City Central Hospital
Taishan Medical University Affiliated Hospital
Weihai Municipal Hospital
Weifang Medical University
Zibo First Hospital
Central Hospital of Zibo
Investigators
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Study Chair: Chunyan Ji, Doctor Shandong University
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Responsible Party: Chunyan Ji, professor, Shandong University
ClinicalTrials.gov Identifier: NCT02985372    
Other Study ID Numbers: ESDCLDC in NDEAML
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Cytarabine
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors