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

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ClinicalTrials.gov Identifier: NCT02985372

Recruitment Status : Unknown

Verified November 2016 by Chunyan Ji, Shandong University.
Recruitment status was: Enrolling by invitation

First Posted : December 7, 2016

Last Update Posted : December 7, 2016

Sponsor:

Collaborators:

Binzhou Medical University

Shengli Oilfield Central Hospital

Heze Municipal Hospital

Jinan Military Genaral Hospital

Jinan Central Hospital

Jining Medical University

Linyi People's Hospital

Qingdao University

People's Hospital of Rizhao

Shandong Provincial Qianfoshan Hospital

Qilu Hospital of Shandong University (Qingdao)

Taian City Central Hospital

Taishan Medical University Affiliated Hospital

Weihai Municipal Hospital

Weifang Medical University

Zibo First Hospital

Central Hospital of Zibo

Information provided by (Responsible Party):

Chunyan Ji, Shandong University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Acute Myeloid Leukemia, Adult	Drug: Decitabine Drug: Cytarabine	Phase 3

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:

<5% blast in the marrow, enter into maintenance therapy (Group A)
≥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)
marrow blast decline <60%, dropped out of the study (Group C).

Maintenance therapy regimen:

Ara-C 1g/m2/d iv drip d1-4 1 cycle
DEC 15mg/m2/d iv drip d1-5 1 cycle
Ara-C 1g/m2/d iv drip d1-4 1 cycle
DEC 15mg/m2/d iv drip d1-5 1 cycle

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	N/A
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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 Start Date :	December 2016
Estimated Primary Completion Date :	December 2018
Estimated Study Completion Date :	December 2019

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial acute myeloid leukemia with mutated CEBPA Cytogenetically normal acute myeloid leukemia Core binding factor acute myeloid leukemia

MedlinePlus related topics: Acute Myeloid Leukemia Leukemia

Drug Information available for: Cytarabine Decitabine

Genetic and Rare Diseases Information Center resources: Myeloid Leukemia Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia

U.S. FDA Resources

Arms and Interventions

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: 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). Drug: Cytarabine

Outcome Measures

Primary Outcome Measures :

Overall response rate [ Time Frame: three years ]
complete remission rate [ Time Frame: three years ]

Secondary Outcome Measures :

Overall survival [ Time Frame: three years ]
progression-free survival [ Time Frame: three years ]
mortality rate [ Time Frame: three years ]
recurrence rate [ Time Frame: three years ]

Eligibility Criteria

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Ages Eligible for Study:	60 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 0-2.
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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985372

Sponsors and Collaborators

Chunyan Ji