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

Sponsor
Chunyan Ji (Other)
Overall Status
Unknown status
CT.gov ID
NCT02985372
Collaborator
Binzhou Medical University (Other), Shengli Oilfield Central Hospital (Other), Heze Municipal Hospital (Other), Jinan Military Genaral Hospital (Other), Jinan Central Hospital (Other), Jining Medical University (Other), Linyi People's Hospital (Other), Qingdao University (Other), Rizhao People's Hospital (Other), Qianfoshan Hospital (Other), Qilu Hospital of Shandong University (Qingdao) (Other), Taian City Central Hospital (Other), Taishan Medical University Affiliated Hospital (Other), Weihai Municipal Hospital (Other), Weifang Medical University (Other), Zibo First Hospital (Other), Central Hospital of Zibo (Other)
30
Enrollment
1
Arm
36
Duration (Months)

Study Details

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
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:

  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)

  1. 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 Design

Study Type:
Interventional
Anticipated 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 :
Dec 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2018
Anticipated Study Completion Date :
Dec 1, 2019

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

  1. Overall response rate [three years]

  2. complete remission rate [three years]

Secondary Outcome Measures

  1. Overall survival [three years]

  2. progression-free survival [three years]

  3. mortality rate [three years]

  4. recurrence rate [three years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Chunyan Ji
  • 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

Investigators

  • Study Chair: Chunyan Ji, Doctor, Shandong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chunyan Ji, professor, Shandong University
ClinicalTrials.gov Identifier:
NCT02985372
Other Study ID Numbers:
  • ESDCLDC in NDEAML
First Posted:
Dec 7, 2016
Last Update Posted:
Dec 7, 2016
Last Verified:
Nov 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Cytarabine
Decitabine

Study Results

No Results Posted as of Dec 7, 2016