NCT03284593

Brief Summary

The treatment of older patients with acute myeloid leukemia that is secondary to previous myelodysplastic syndrome, myeloproliferative neoplasm, or prior cytotoxic exposure remains unsatisfactory. We compared patients treated with intensive chemotherapy or azacitidine within two centres.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
55mo left

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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 Progress72%
Dec 2014Dec 2030

Study Start

First participant enrolled

December 1, 2014

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

16 years

First QC Date

September 13, 2017

Last Update Submit

July 29, 2020

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

  • Survival

    Survival times

    2 years

Study Arms (2)

intensive chemotherapy group

patients treated with intensive chemotherapy

Drug: intensive chemotherapy

Azacitidine group

patients treated with azacitidine

Drug: Azacitidine

Interventions

intensive chemotherapyDRUG
intensive chemotherapy group
AzacitidineDRUG
Azacitidine group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of acute myeloid leukemia between 2000 and 2014 in 2 hospitals in South of France

You may qualify if:

  • patients with acute myeloid leukemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital Bordeaux

Bordeaux, France

Location

University Hospital Toulouse

Toulouse, 31052, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Christian RECHER, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 15, 2017

Study Start

December 1, 2014

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)