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

Primary Purpose

Acute Myeloid Leukemia, Adult

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Decitabine

Cytarabine

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia, Adult

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute myeloid leukemia

Arm 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).

Outcomes

Primary Outcome Measures

Overall response rate

complete remission rate

Secondary Outcome Measures

Overall survival

progression-free survival

mortality rate

recurrence rate

Full Information

NCT ID

NCT02985372

First Posted

November 25, 2016

Last Updated

December 3, 2016

Sponsor

Chunyan Ji

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, Rizhao People's Hospital, 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

1. Study Identification

Unique Protocol Identification Number

NCT02985372

Brief Title

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Chunyan Ji

Collaborators

4. Oversight

Data Monitoring Committee

5. 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).

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia, Adult

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acute myeloid leukemia

Arm Type

Experimental

Arm 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).

Intervention Type

Drug

Intervention Name(s)

Decitabine

Intervention 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).

Intervention Type

Drug

Intervention Name(s)

Cytarabine

Primary Outcome Measure Information:

Title

Overall response rate

Time Frame

three years

Title

complete remission rate

Time Frame

three years

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

three years

Title

progression-free survival

Time Frame

three years

Title

mortality rate

Time Frame

three years

Title

recurrence rate

Time Frame

three years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 0-2. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chunyan Ji, Doctor

Organizational Affiliation

Shandong University

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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