Myeloproliferative DisordersESAACNCT05001386
In Vitro Drug Sensitivity Testing of Fresh Human Samples
A study testing Blood collection for the evaluation of the anti-drugs sensitivity in people with Myeloproliferative Disorders and Lymphoproliferative Disorders, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Hematological malignancies gather several various pathologies included myeloproliferative disorders (as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML)) and lymphoproliferative disorders (as chronic lymphoid leukemia (CLL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM)) . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myeloproliferative Disorders, Lymphoproliferative Disorders
- What is being tested?
- Blood collection for the evaluation of the anti-drugs sensitivity
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 2 sitesFrance
- Study dates
- Mar 2022to Mar 2025
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Index cases: patients with myeloproliferative or lymphoproliferative disorders.
- Controls: patients without hematological disease, without chemotherapy ((≤ 5 years.) and without immunosuppressive treatment at the study time.
- Age ≥ 18 y.o for all the patients
Who cannot join
- Age < 18 y.o
- Pregnant or breastfeeding woman
- Patients deprived of their liberty by judicial or administrative decision.
Trial locations and contacts
2 sites in 1 country.
Marc Pr BONNEFOY, MD contact
France2 sites
Centre Hospitalier Lyon Sud -Service d'Hématologie
Pierre-Bénite, 69495
Charles DUMONTET, MD, 0478468340, charles.dumontet@chu-lyon.fr
Centre Hospitalier Lyon Sud -Service de médecine du vieillissement
Pierre-Bénite, 69495
Marc BONNEFOY, MD, 0478861580, marc.bonnefoy@chu-lyon.fr
About this study
Official title: Evaluation of Anti-cancer Drugs Sensitivity on Fresh Samples From Healthy Patients and Patients With Myeloproliferative or Lymphoproliferative Disorders
Hematological malignancies gather several various pathologies included myeloproliferative disorders (as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML)) and lymphoproliferative disorders (as chronic lymphoid leukemia (CLL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM)) .
Over the last decade, the treatments have evolved significantly but the overall survival remains limited, especially for the AML and MM patients. There's an ongoing imperative to continue in-vitro and in-vivo studies to better evaluate the anti-cancer drugs sensitivity and therefore improving the response to treatments and open new fields of application. The healthy control group will be contributing to produce some pertinent and significant data for the results of the index cases group.
The investigators aim to analyze 10 differents drugs, common use in chemotherapy or immunotherapy and evaluate by 2 ways the sensitivity: first, Flow cytometry (cells apoptosis by Annexine V and propidium iodide) on fresh samples and in a second time, monitoring of the blasts in the mouse's blood after injection.
- Being tested
- Blood collection for the evaluation of the anti-drugs sensitivity
- Keywords
- Hematological malignancies, lymphoid, myeloid, multiple myeloma, anticancer drugs, sensitivity, new treatments
- Medical subject headings
- Myeloproliferative Disorders, Lymphoproliferative Disorders, Hematologic Neoplasms, Multiple Myeloma, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collection for the evaluation of the anti-drugs sensitivityBiological
The M.D investigators and the medical team identify the patients ( index cases and healthy volunteers) in a medical appointment. They inform them, collect the non-opposition right and the blood samples: 5 mL heparin tube and 5 mL dry tube for each person , one time.
| Study group | Role | What they receive |
|---|---|---|
| Lymphoproliferative disorders | Experimental | Patients followed in the haematology unit of Hospices Civils de Lyon for lymproliferative disorders as chronic lymphoid leukemia (CLL), non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) . Receives: Biological: Blood collection for the evaluation of the anti-drugs sensitivity |
| Control group | Sham comparator | Patients followed in the medicine of aging unit in the Hospices Civils de Lyon without haematological malignancies, without chemotherapy and without immunosuppressive treatment (≤ 5 years) Receives: Biological: Blood collection for the evaluation of the anti-drugs sensitivity |
| Myeloproliferative disorders | Experimental | Patients followed in the haematology unit of Hospices Civils de Lyon for myeloproliferative disorders as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). Receives: Biological: Blood collection for the evaluation of the anti-drugs sensitivity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the sensitivity of 10 anti-cancer drugs
Sensitivity determined by in-vitro
- Tumor cells mortality by Flow cytometry
- Monitoring of the blasts in the mouse's blood after injection
Measured: Through study completion, an average of 3 years
Evaluation of the sensitivity of 10 anti-cancer drugs
Sensitivity determined by in-vivo fresh samples:
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study startMar 2022 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001386
- Sponsor's protocol ID
- 69HCL21_0622
- Acronym
- ESAAC
- Status last verified
- Mar 2022
- First submitted
- 27 Jul 2021
- Last updated
- 17 Mar 2022
- 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 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anti-cancer Drugs Sensitivity on Fresh Samples From Healthy Patients and Patients With Myeloproliferative or Lymphoproliferative Disorders
- ClinicalTrials.gov ID
- NCT05001386
- Acronym / sponsor ID
- ESAAC / 69HCL21_0622
- Keywords
- Hematological malignancies, lymphoid, myeloid, multiple myeloma, anticancer drugs, sensitivity, new treatments
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Mar 2022 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 11 Aug 2021 (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.
Hematological malignancies gather several various pathologies included myeloproliferative disorders (as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML)) and lymphoproliferative disorders (as chronic lymphoid leukemia (CLL), non-Hodgkin lymphoma (NHL) and multiple myeloma (MM)) .
Over the last decade, the treatments have evolved significantly but the overall survival remains limited, especially for the AML and MM patients. There's an ongoing imperative to continue in-vitro and in-vivo studies to better evaluate the anti-cancer drugs sensitivity and therefore improving the response to treatments and open new fields of application. The healthy control group will be contributing to produce some pertinent and significant data for the results of the index cases group.
The investigators aim to analyze 10 differents drugs, common use in chemotherapy or immunotherapy and evaluate by 2 ways the sensitivity: first, Flow cytometry (cells apoptosis by Annexine V and propidium iodide) on fresh samples and in a second time, monitoring of the blasts in the mouse's blood after injection.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lymphoproliferative disorders | Experimental | Biological: Blood collection for the evaluation of the anti-drugs sensitivityPatients followed in the haematology unit of Hospices Civils de Lyon for lymproliferative disorders as chronic lymphoid leukemia (CLL), non-Hodgkin lymphoma (NHL) or multiple myeloma (MM) . |
| Control group | Sham comparator | Biological: Blood collection for the evaluation of the anti-drugs sensitivityPatients followed in the medicine of aging unit in the Hospices Civils de Lyon without haematological malignancies, without chemotherapy and without immunosuppressive treatment (≤ 5 years) |
| Myeloproliferative disorders | Experimental | Biological: Blood collection for the evaluation of the anti-drugs sensitivityPatients followed in the haematology unit of Hospices Civils de Lyon for myeloproliferative disorders as acute myeloid leukemia (AML) or chronic myeloid leukemia (CML). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Index cases: patients with myeloproliferative or lymphoproliferative disorders.
- Controls: patients without hematological disease, without chemotherapy ((≤ 5 years.) and without immunosuppressive treatment at the study time.
- Age ≥ 18 y.o for all the patients
Key exclusion criteria (3 listed)
- Age < 18 y.o
- Pregnant or breastfeeding woman
- Patients deprived of their liberty by judicial or administrative decision.
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 |
|---|---|---|
| Blood collection for the evaluation of the anti-drugs sensitivityThe M.D investigators and the medical team identify the patients ( index cases and healthy volunteers) in a medical appointment. They inform them, collect the non-opposition right and the blood samples: 5 mL heparin tube and 5 mL dry tube for each person , one time. | Biological | Control group, Lymphoproliferative disorders, Myeloproliferative disorders |
Primary outcome
Evaluation of the sensitivity of 10 anti-cancer drugs
Time frame: Through study completion, an average of 3 years
Sensitivity determined by in-vitro * Tumor cells mortality by Flow cytometry * Monitoring of the blasts in the mouse's blood after injection
Evaluation of the sensitivity of 10 anti-cancer drugs
Time frame: Through study completion, an average of 3 years
Sensitivity determined by in-vivo fresh samples:
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
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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.
Marc Pr BONNEFOY, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood collection for the evaluation of the anti-drugs sensitivity in people with Myeloproliferative Disorders and Lymphoproliferative Disorders, run by Hospices Civils de Lyon at 2 sites 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 3 inclusion and 3 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 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Charles Pr DUMONTET, PhD, MD (0478468340, charles.dumontet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the sensitivity of 10 anti-cancer drugs (time frame: Through study completion, an average of 3 years). The study lists 2 primary outcomes in all. 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 17 Mar 2022.