Acute T Lymphoblastic Leukemia (T-ALL)HSP-HEMATONCT04437420
Preclinical Project on the Traitment of Acute Lymphoblastique Leukemia With NVP-BEP800, an Inhibitor of the Heat Shock Protein HSP90
An observational study of Acute T Lymphoblastic Leukemia (T-ALL) and Acute B Lymphoblastic Leukemia (B-ALL), run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute T Lymphoblastic Leukemia (T-ALL), Acute B Lymphoblastic Leukemia (B-ALL)
- What is being tested?
- injection of BEP 800
- Type of treatment
- Injection or infusion
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2019to Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with acute lymphoblastic leukemia with biological samples stored at the Biology Technical Platform.
Who may be able to join
- Patient suffering from acute lymphoblastic leukaemia whose biological samples are kept at the Biology Technical Platform.
Who cannot join
- Patient over 80 years of age
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Chu Dijon Bourgogne
Dijon, 21000
Shaliha Bechoua, shaliha.bechoua@chu-dijon.fr
About this study
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).
- Being tested
- injection of BEP 800, Control
- Medical subject headings
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of BEP 800Drug
injection of BEP 800
ControlOther
no injection of BEP 800
| Study group | Role | What they receive |
|---|---|---|
| T-ALL | Not described Receives: Drug: injection of BEP 800; Other: Control | |
| B-ALL | Not described Receives: Drug: injection of BEP 800; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Effect on SRC phosphorylation
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Nov 2019
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute T Lymphoblastic Leukemia (T-ALL)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437420
- Sponsor's protocol ID
- GIRODON Collection 2020
- Acronym
- HSP-HEMATO
- Status last verified
- Jun 2020
- First submitted
- 16 Jun 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preclinical Project on the Traitment of Acute Lymphoblastique Leukemia With NVP-BEP800, an Inhibitor of the Heat Shock Protein HSP90
- ClinicalTrials.gov ID
- NCT04437420
- Acronym / sponsor ID
- HSP-HEMATO / GIRODON Collection 2020
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T-ALL | – | Drug: injection of BEP 800, Other: Control |
| B-ALL | – | Drug: injection of BEP 800, Other: Control |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with acute lymphoblastic leukemia with biological samples stored at the Biology Technical Platform.
Key inclusion criteria (1 listed)
- Patient suffering from acute lymphoblastic leukaemia whose biological samples are kept at the Biology Technical Platform.
Key exclusion criteria (1 listed)
- Patient over 80 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection of BEP 800injection of BEP 800 | Drug | B-ALL, T-ALL |
| Controlno injection of BEP 800 | Other | B-ALL, T-ALL |
Primary outcome
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.
1 secondary outcome
Effect on SRC phosphorylation
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute T Lymphoblastic Leukemia (T-ALL) and Acute B Lymphoblastic Leukemia (B-ALL), run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact François GIRODON (0380295710 ext. +33, francois.girodon@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viability on primary ALL samples (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.