Clinical trial NCT02985372: Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acute Myeloid Leukemia, Adult
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Binzhou Medical University
name: Shengli Oilfield Hospital
name: Heze Municipal Hospital
name: Jinan Military Genaral Hospital
name: Jinan Central Hospital
name: Jining Medical University
name: Linyi People's Hospital
name: Qingdao University
name: Rizhao People's Hospital
name: Qianfoshan Hospital
name: Qilu Hospital of Shandong University (Qingdao)
name: Taian City Central Hospital
name: Taishan Medical University Affiliated Hospital
name: Weihai Municipal Hospital
name: Weifang Medical University
name: Zibo First Hospital
name: Central Hospital of Zibo
First posted: 2016-12-07
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Overall response rate
timeFrame: three years
measure: complete remission rate
timeFrame: three years
Secondary outcomes:
measure: Overall survival
timeFrame: three years
measure: progression-free survival
timeFrame: three years
measure: mortality rate
timeFrame: three years
measure: recurrence rate
timeFrame: three years
Other outcomes:
Locations:
Study officials:
affiliation: Shandong University
name: Chunyan Ji, Doctor
role: STUDY_CHAIR
References: