NCT02432911

Brief Summary

This study focus on the comparison of CAG regimen to the low dose cytarabine therapy in elderly AML patients who are unfit or unwilling to receive intensive chemotherapy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

April 29, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

October 7, 2016

Status Verified

May 1, 2016

Enrollment Period

3.1 years

First QC Date

April 29, 2015

Last Update Submit

October 6, 2016

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • overall survival

    3 years

Secondary Outcomes (3)

  • complete remission rate

    4 months

  • relapse free survival

    3 years

  • treatment-related mortality

    2 months

Study Arms (2)

CAG regimen

EXPERIMENTAL

Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy.

Drug: CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)

Low dose cytarabine

ACTIVE COMPARATOR

cytarabine 20mg bid for 10 days.

Drug: low dose cytarabine

Interventions

CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)DRUG

Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy.

CAG regimen
low dose cytarabineDRUG

cytarabine 20mg bid for 10 days.

Also known as: cytarabine
Low dose cytarabine

Eligibility Criteria

Age65 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Acute myeloid leukemia except APL
  • ECOG PS：0-3
  • Unfit or unwilling to receive intensive therapy

You may not qualify if:

  • The one who has already received induction therapy no matter what the outcome is.
  • Active cancer patients who are needed to receive treatment;
  • Serious uncontrolled infectious diseases(eg.tuberculosis or invasive pulmonary aspergillosis）；
  • Active heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treatment and Diagnosis Center of Leukemia

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

CAG protocolaclacinomycinsCytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Jianxiang Wang, MD

CONTACT

+862223909120wangjx@cams.ac.cn

Chunlin Zhou, MD

CONTACT

+8613820429085zhouchunlin@cams.ac.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
UNKNOWN
Responsible Party
SPONSOR INVESTIGATOR
PI Title
vice-president

Study Record Dates

First Submitted

April 29, 2015

First Posted

May 4, 2015

Study Start

April 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 1, 2021

Last Updated

October 7, 2016

Record last verified: 2016-05

Locations

CN(1)