NCT02619071

Brief Summary

Adult acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy associated with poor prognosis, especially after relapse. High-throughput genomic studies have highlighted the importance of molecular alteration in the pathophysiology, clinical evolution and treatment response of AML. In addition, identification of specific gene mutation can be targeted by specific inhibitors, opening the way to personalized treatments. However, only a limited number of gene mutations are druggable or actionable, highlighting the need for additional information to guide treatment choices. Among them, new Drug Screening Tests (DST) allow for the screening of library of hundreds of drugs to ex-vivo patient-derived AML cells. Combination of genomic and pharmacologic approaches might therefore improve prediction of drug effects. There is an urgent need to bring these approaches into the clinic but feasibility trials are necessary before incorporating them into treatments strategies.The proposed study is a prospective multicentre feasibility study of a combined "chemo-genomic" approach in patients with advanced AML.

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
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration 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

August 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

June 28, 2016

Status Verified

June 1, 2016

Enrollment Period

2 years

First QC Date

November 30, 2015

Last Update Submit

June 27, 2016

Conditions

Leukemia, Myeloid, Acute

Keywords

acute myeloid leukemia- refractory AML- relapsed AML- precision medecine-

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients for whom a treatment tailored according to chemogenomic data could be proposed to the investigator within a 21 days time-frame in at least 30% of cases.

    24 months

Secondary Outcomes (1)

  • Correlations between genomic alterations (identified by mutatome and transcriptome analyses) and drug sensitivity profiles

    24 months

Study Arms (1)

Refractory or relapsed acute myeloid leukemia

EXPERIMENTAL
Procedure: Tumor samplingBiological: Constiutional DNA sampling

Interventions

Tumor samplingPROCEDURE

Bone marrow aspirate, blood sampling

Refractory or relapsed acute myeloid leukemia
Constiutional DNA samplingBIOLOGICAL

Buccal swab or Hair follicles

Refractory or relapsed acute myeloid leukemia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 years
  • Diagnosis of acute myeloid leukemia according to WHO classification
  • Refractory or relapsed disease
  • ECOG performance status of \<3
  • Life expectancy \>3 months
  • Written informed consent
  • Affiliation to the French Social Security System.

You may not qualify if:

  • Diagnosis of Acute Promyelocytic Leukemia.
  • Patients deprived of liberty or placed under the authority of a tutor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut PAOLI-CALMETTES

Marseille, France

RECRUITING

Related Publications (1)

  • Collignon A, Hospital MA, Montersino C, Courtier F, Charbonnier A, Saillard C, D'Incan E, Mohty B, Guille A, Adelaide J, Carbuccia N, Garnier S, Mozziconacci MJ, Zemmour C, Pakradouni J, Restouin A, Castellano R, Chaffanet M, Birnbaum D, Collette Y, Vey N. A chemogenomic approach to identify personalized therapy for patients with relapse or refractory acute myeloid leukemia: results of a prospective feasibility study. Blood Cancer J. 2020 Jun 3;10(6):64. doi: 10.1038/s41408-020-0330-5.

    PMID: 32488055DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Dominique Genre, MD

CONTACT

+33491223778drci.up@ipc.unicancer.fr

Jihane PAKRADOUNI, PharmD,PhD

CONTACT

+33491223778drci.up@ipc.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 2, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

June 28, 2016

Record last verified: 2016-06

Locations

FR(1)