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

Efficacy and Safety of Decitabine in Combination With Low-dose Cytarabine as Inductive Treatment in Newly Diagnosed Elderly Patients With Acute Myeloid Leukemia

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).

Study Overview

• Status: Unknown
• Conditions: Acute Myeloid Leukemia, Adult
• Intervention / Treatment: Drug: Cytarabine; Drug: Decitabine

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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: Cytarabine; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall response rate	three years
complete remission rate	three years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	three years
progression-free survival	three years
mortality rate	three years
recurrence rate	three years

Collaborators and Investigators

• Sponsor: Chunyan Ji
• Collaborators: Qingdao University; Qianfoshan Hospital; Jinan Central Hospital; Jining Medical University; Linyi People's Hospital; Weihai Municipal Hospital; Taian City Central Hospital; Weifang Medical University; Qilu Hospital of Shandong University (Qingdao); Binzhou Medical University; Rizhao People's Hospital; Heze Municipal Hospital; Shengli Oilfield Central Hospital; Jinan Military Genaral Hospital; Taishan Medical University Affiliated Hospital; Zibo First Hospital; Central Hospital of Zibo
• Investigators: Study Chair: Chunyan Ji, Doctor, Shandong University

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2018
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: November 25, 2016
• First Submitted That Met QC Criteria: December 3, 2016
• First Posted (ESTIMATE): December 7, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 7, 2016
• Last Update Submitted That Met QC Criteria: December 3, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Decitabine; Cytarabine
• Other Study ID Numbers: ESDCLDC in NDEAML

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED