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

Phase 3

• Conditions: Acute Myeloid Leukemia, Adult
• Interventions: Drug: Decitabine; Drug: Cytarabine

• Registration Number: NCT02985372
• Lead Sponsor: Chunyan Ji

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

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-25
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-03
• Last Update Submitted: 2016-12-03
• Study First Posted: 2016-12-07
• Last Update Posted: 2016-12-07
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute myeloid leukemia	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).
Acute myeloid leukemia	Cytarabine	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).

Primary Outcome Measures

Name	Time	Method
Overall response rate	three years
complete remission rate	three years

Secondary Outcome Measures

Name	Time	Method
recurrence rate	three years
mortality rate	three years
Overall survival	three years
progression-free survival	three years