NCT04437420

Brief Summary

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).

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
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2019

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

November 1, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 18, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

1.8 years

First QC Date

June 16, 2020

Last Update Submit

June 19, 2020

Conditions

Acute T Lymphoblastic Leukemia (T-ALL)Acute B Lymphoblastic Leukemia (B-ALL)

Outcome Measures

Primary Outcomes (1)

  • Viability on primary ALL samples

    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 Outcomes (1)

  • Effect on SRC phosphorylation

    2 years

Study Arms (2)

T-ALL

Drug: injection of BEP 800Other: Control

B-ALL

Drug: injection of BEP 800Other: Control

Interventions

injection of BEP 800DRUG

injection of BEP 800

B-ALLT-ALL
ControlOTHER

no injection of BEP 800

B-ALLT-ALL

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patient over 80 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Central Study Contacts

François GIRODON

CONTACT

0380295710francois.girodon@chu-dijon.fr

Study Design

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

Study Record Dates

First Submitted

June 16, 2020

First Posted

June 18, 2020

Study Start

November 1, 2019

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

June 23, 2020

Record last verified: 2020-06

Locations

FR(1)