NCT02985372

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2016

Typical duration for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

December 7, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

November 25, 2016

Last Update Submit

December 3, 2016

Conditions

Acute Myeloid Leukemia, Adult

Outcome Measures

Primary Outcomes (2)

  • Overall response rate

    three years

  • complete remission rate

    three years

Secondary Outcomes (4)

  • Overall survival

    three years

  • progression-free survival

    three years

  • mortality rate

    three years

  • recurrence rate

    three years

Study Arms (1)

Acute myeloid leukemia

EXPERIMENTAL

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: DecitabineDrug: Cytarabine

Interventions

DecitabineDRUG

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
CytarabineDRUG
Acute myeloid leukemia

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

DecitabineCytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

AzacitidineAza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesArabinonucleosides

Study Officials

  • Chunyan Ji, Doctor

    Shandong University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 25, 2016

First Posted

December 7, 2016

Study Start

December 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2019

Last Updated

December 7, 2016

Record last verified: 2016-11