Efficacy and Safety of Decitabine in Combination With Low-dose Cytarabine as Inductive Treatment in Newly Diagnosed Elderly Patients With Acute Myeloid Leukemia
Overview
- Phase
- Phase 3
- Intervention
- Decitabine
- Conditions
- Acute Myeloid Leukemia, Adult
- Sponsor
- Chunyan Ji
- Enrollment
- 30
- Primary Endpoint
- Overall response rate
- Last Updated
- 9 years ago
Overview
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).
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
Investigators
Chunyan Ji
professor
Shandong University
Eligibility Criteria
Inclusion Criteria
- •Patients with previously untreated non-M3 AML (diagnosed by the WHO2016 criteria).
- •Age: ≥ 60 and ≤ 75 years.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-
- •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)≤2.5x upper limit of normal (ULN), total bilirubin ≤ 1.5 ULN, serum creatinine \< 2ULN.
- •Without central nervous system symptoms.
- •Willing to accept the follow-up.
- •Normal heart function(EF\>50%). The subjects volunteer to sign the informed consent.
Exclusion Criteria
- •With severe cardiac, renal or hepatic insufficiency.
- •With other cancers requiring treatment.
- •With other hematological diseases(e.g. Hemophilia, myelofibrosis, etc.).
- •With severe infection or metabolic disease(including tuberculosis and pulmonary aspergillosis).
- •Brain disorders or severe mental diseases which could limit compliance with study requirements.
- •Major operation within 3 weeks.
- •With HIV infection or AIDS-associated diseases.
- •Any drug abuse, medical, mental or social situations which would affect the results.
- •Hypersensitivity to cytarabine (not including drug fever or exanthema) or decitabine.
Arms & Interventions
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).
Intervention: Decitabine
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).
Intervention: Cytarabine
Outcomes
Primary Outcomes
Overall response rate
Time Frame: three years
complete remission rate
Time Frame: three years
Secondary Outcomes
- recurrence rate(three years)
- mortality rate(three years)
- Overall survival(three years)
- progression-free survival(three years)