Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia
NCT ID: NCT02985372
Last Updated: 2016-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
30 participants
INTERVENTIONAL
2016-12-31
2019-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
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).
Cytarabine
Interventions
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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).
Cytarabine
Eligibility Criteria
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Inclusion 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
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.
60 Years
75 Years
ALL
No
Sponsors
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Binzhou Medical University
OTHER
Shengli Oilfield Hospital
OTHER
Heze Municipal Hospital
OTHER
Jinan Military Genaral Hospital
UNKNOWN
Jinan Central Hospital
OTHER
Jining Medical University
OTHER
Linyi People's Hospital
OTHER
Qingdao University
OTHER
Rizhao People's Hospital
OTHER
Qianfoshan Hospital
OTHER
Qilu Hospital of Shandong University (Qingdao)
OTHER
Taian City Central Hospital
OTHER
Taishan Medical University Affiliated Hospital
OTHER
Weihai Municipal Hospital
OTHER
Weifang Medical University
OTHER
Zibo First Hospital
OTHER
Central Hospital of Zibo
OTHER
Chunyan Ji
OTHER
Responsible Party
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Chunyan Ji
professor
Principal Investigators
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Chunyan Ji, Doctor
Role: STUDY_CHAIR
Shandong University
Other Identifiers
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ESDCLDC in NDEAML
Identifier Type: -
Identifier Source: org_study_id