Preclinical Project on the Traitment of Acute Lymphoblastique Leukemia With NVP-BEP800, an Inhibitor of the Heat Shock Protein HSP90 (HSP-HEMATO)

June 19, 2020 updated by: Centre Hospitalier Universitaire Dijon
NVP-BEP800, a new HSP90 inhibitor, has particularly interesting therapeutic potential and represents hope in cancer pathologies. While it is currently being tested for solid cancers, no preclinical study has yet demonstrated its effectiveness in acute lymphoblastique leukemia (ALL). The investigators wish to study the effects of NVP-BEP800 on two different types of ALL (T and B-ALL).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with acute lymphoblastic leukemia with biological samples stored at the Biology Technical Platform.

Description

Inclusion Criteria:

  • Patient suffering from acute lymphoblastic leukaemia whose biological samples are kept at the Biology Technical Platform.

Exclusion Criteria:

  • Patient over 80 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
T-ALL
Drug: injection of BEP 800
injection of BEP 800
Other: Control
no injection of BEP 800
B-ALL
Drug: injection of BEP 800
injection of BEP 800
Other: Control
no injection of BEP 800

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viability on primary ALL samples
Time Frame: 2 years
The effect of BEP-800 after 48 hours of treatment on T-ALL and B-ALL will be evaluated by counting viable cells by flow cytometry with a viability marker and specific antibodies to detect leukemia cells.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on SRC phosphorylation
Time Frame: 2 years
The effect of BEP-800 on T-ALL and B-ALL will be evaluated by flow cytometry by measuring HSP90 and SRC (phosphorylated), by intracellular labeling after permeabilization of the cells, 18 hours after treatment with BEP-800.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

June 16, 2020

First Submitted That Met QC Criteria

June 17, 2020

First Posted (Actual)

June 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 19, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIRODON Collection 2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

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