Acute LeukemiaHEMATO-BIONCT02320656
Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015
A study testing Blood sampling, Bone marrow aspirate and Skin biopsy in people with Acute Leukemia and Myelodysplastic Syndromes, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia, Myelodysplastic Syndromes, Myeloproliferative Disorders
- What is being tested?
- Blood sampling, Bone marrow aspirate and Skin biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to 30 Oct 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute leukemia, myelodysplastic syndrome or myeloproliferative disease
- age > 18
- affiliated to the French Social Security Systm
- signed informed consent
Who cannot join
- emergency
- patients deprived of liberty or placed under the authority of a tutor
Trial locations and contacts
1 site in 1 country.
About this study
HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.
HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse:
- tumor samples: marrow aspiration, blood sampling.
- non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center.
- Being tested
- Blood sampling, Bone marrow aspirate, Skin biopsy, Buccal swab
- Medical subject headings
- Myelodysplastic Syndromes, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Longitudinal (3 stages of the disease)
Bone marrow aspirateOther
Longitudinal (3 stages of the disease)
Skin biopsyOther
Single biopsy (optional)
Buccal swabOther
Single sampling.
| Study group | Role | What they receive |
|---|---|---|
| Acute leukemia/myelodysplastic or myeloproliferative disease | Experimental | Not described Receives: Other: Blood sampling; Other: Bone marrow aspirate; Other: Skin biopsy; Other: Buccal swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)
Measured: up to 8 years
Secondary outcomes (2)
Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival)
Measured: up to 8 years
Compare cancer and non-tumor cells genome
Measured: up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startMay 2014
- Primary completion30 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert Vey, MD,PhD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320656
- Sponsor's protocol ID
- HEMATO-BIO-IPC-2013-015
- Acronym
- HEMATO-BIO
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2014
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Chretien AS, Devillier R, Granjeaud S, Cordier C, Demerle C, Salem N, Wlosik J, Orlanducci F, Gorvel L, Fattori S, Hospital MA, Pakradouni J, Gregori E, Paul M, Rochigneux P, Pagliardini T, Morey M, Fauriat C, Dulphy N, Toubert A, Luche H, Malissen M, Blaise D, Nunes JA, Vey N, Olive D. High-dimensional mass cytometry analysis of NK cell alterations in AML identifies a subgroup with adverse clinical outcome. Proc Natl Acad Sci U S A. 2021 Jun 1;118(22):e2020459118. doi: 10.1073/pnas.2020459118.
PubMed 34050021Grenier JMP, Testut C, Bal M, Bardin F, De Grandis M, Gelsi-Boyer V, Vernerey J, Delahaye M, Granjeaud S, Zemmour C, Spinella JF, Chavakis T, Mancini SJC, Boher JM, Hebert J, Sauvageau G, Vey N, Schwaller J, Hospital MA, Fauriat C, Aurrand-Lions M. Genetic deletion of JAM-C in preleukemic cells rewires leukemic stem cell gene expression program in AML. Blood Adv. 2024 Sep 10;8(17):4662-4678. doi: 10.1182/bloodadvances.2023011747.
PubMed 38954834Garciaz S, Montersino C, Bourgoin M, Jacquel A, Castellano R, Guille A, Chaffanet M, Bertucci F, Hospital MA, Adelaide J, Auberger P, Vey N, Collette Y. Dasatinib overcomes AML cells resistant to BCL2 inhibition by degrading MCL1. Br J Haematol. 2025 Jun 6;207(2):381-6. doi: 10.1111/bjh.20195. Online ahead of print.
PubMed 40474797
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Clinical and Biological Parameters in Acute Leukemia, Myelodysplastic Syndromes and Myeloproliferative Disorders-HEMATO-BIO-IPC-2013-015
- ClinicalTrials.gov ID
- NCT02320656
- Acronym / sponsor ID
- HEMATO-BIO / HEMATO-BIO-IPC-2013-015
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 19 Dec 2014 (estimated)
- 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.
HEMATO-BIO-IPC-2013-015 is a monocenter prospective longitudinal study. Our aim is to define predictive clinical and biological factors in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by using genomics, genetics and epigenetics, in vitro and in vivo drug sensitivity studies,and translational immonulogy and immunomonitoring studies.
HEMATO-BIO primary outcome measure is to identify molecular, genomic and epigenetic, pharmacologic and immunophenotypic alteration in acute leukemia, myelodysplastic syndromes and myeloproliferative disorders by collecting, at diagnosis and/or complete remission and/or relapse:
- tumor samples: marrow aspiration, blood sampling.
- non-tumor samples: skin biopsy, buccal swab . from 650 patients treated at our cancer center.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute leukemia/myelodysplastic or myeloproliferative disease | Experimental | Other: Blood sampling, Other: Bone marrow aspirate, Other: Skin biopsy, Other: Buccal swab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- acute leukemia, myelodysplastic syndrome or myeloproliferative disease
- age > 18
- affiliated to the French Social Security Systm
- signed informed consent
Key exclusion criteria (2 listed)
- emergency
- patients deprived of liberty or placed under the authority of a tutor
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 samplingLongitudinal (3 stages of the disease) | Other | Acute leukemia/myelodysplastic or myeloproliferative disease |
| Bone marrow aspirateLongitudinal (3 stages of the disease) | Other | Acute leukemia/myelodysplastic or myeloproliferative disease |
| Skin biopsySingle biopsy (optional) | Other | Acute leukemia/myelodysplastic or myeloproliferative disease |
| Buccal swabSingle sampling. | Other | Acute leukemia/myelodysplastic or myeloproliferative disease |
Primary outcome
Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping)
Time frame: up to 8 years
2 secondary outcomes
Correlation between molecular alteration and clinical characteristics(diagnosis,cytogenetics,overall survival, progression free survival)
Time frame: up to 8 years
Compare cancer and non-tumor cells genome
Time frame: up to 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Results publication: PubMed 34050021Chretien AS, Devillier R, Granjeaud S, Cordier C, Demerle C, Salem N, Wlosik J, Orlanducci F, Gorvel L, Fattori S, Hospital MA, Pakradouni J, Gregori E, Paul M, Rochigneux P, Pagliardini T, Morey M, Fauriat C, Dulphy N, Toubert A, Luche H, Malissen M, Blaise D, Nunes JA, Vey N, Olive D. High-dimensional mass cytometry analysis of NK cell alterations in AML identifies a subgroup with adverse clinical outcome. Proc Natl Acad Sci U S A. 2021 Jun 1;118(22):e2020459118. doi: 10.1073/pnas.2020459118.
- Results publication: PubMed 38954834Grenier JMP, Testut C, Bal M, Bardin F, De Grandis M, Gelsi-Boyer V, Vernerey J, Delahaye M, Granjeaud S, Zemmour C, Spinella JF, Chavakis T, Mancini SJC, Boher JM, Hebert J, Sauvageau G, Vey N, Schwaller J, Hospital MA, Fauriat C, Aurrand-Lions M. Genetic deletion of JAM-C in preleukemic cells rewires leukemic stem cell gene expression program in AML. Blood Adv. 2024 Sep 10;8(17):4662-4678. doi: 10.1182/bloodadvances.2023011747.
- Results publication: PubMed 40474797Garciaz S, Montersino C, Bourgoin M, Jacquel A, Castellano R, Guille A, Chaffanet M, Bertucci F, Hospital MA, Adelaide J, Auberger P, Vey N, Collette Y. Dasatinib overcomes AML cells resistant to BCL2 inhibition by degrading MCL1. Br J Haematol. 2025 Jun 6;207(2):381-6. doi: 10.1111/bjh.20195. Online ahead of print.
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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.
Norbert Vey, MD,PhD principal investigator
Institut Paoli-Calmettes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling, Bone marrow aspirate and Skin biopsy in people with Acute Leukemia and Myelodysplastic Syndromes, run by Institut Paoli-Calmettes 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 21 Apr 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute leukemia/ Myeloproliferative/ myelodysplastic syndrome cells profiling (molecular analysis, epigenetic profile, drug sensitivity profile,immunophenotyping) (time frame: up to 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320656, which also lists 3 linked publications.
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 21 Apr 2026.