Hematologic CancerNCT05602168
Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance
A study testing experimental:Acute leukemia/myelodysplastic or myeloproliferative disease in people with Hematologic Cancer, run by Institut Paoli-Calmettes.
Trial summary
The main objective is to study the genomic, transcriptomic, proteomic epigenomic, metabolomic and immune mechanisms of blasts and microenvironment cells associated with IT resistance through the constitution of a collection associating blood or marrow samples from patients with LA, MDS and MPS marrow samples from… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Cancer
- What is being tested?
- experimental:Acute leukemia/myelodysplastic or myeloproliferative disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Diagnosis of acute leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML) or myeloproliferative syndrome according to the WHO classification 2016,
- Patient for whom a new line of therapy is initiated.
- Patient older than 18 years of age.
- Patient affiliated to the social security system or benefiting from such a system.
- Signed consent to participate.
Who cannot join
- Weight at inclusion < 50 kg
- Participating in another clinical study that would cause the total amount of blood collection to exceed the and endanger the patient
- Person in an emergency situation, adult under legal protection (guardianship, curatorship, etc.) protection (guardianship, curatorship or safeguard of justice), or unable to express his or her consent.
- Impossibility to submit to the medical follow-up of the trial for geographical social or psychological reasons,
- Pregnant or breastfeeding women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance: HEMATOBIO.02-IPC 2021-061
The main objective is to study the genomic, transcriptomic, proteomic epigenomic, metabolomic and immune mechanisms of blasts and microenvironment cells associated with IT resistance through the constitution of a collection associating blood or marrow samples from patients with LA, MDS and MPS marrow samples from patients with LA, MDS and MPS at diagnosis, during treatment and at relapse and relapse and clinical annotations.
Read the detailed description
It is a collection of blood, marrow and oral epithelial cell samples taken longitudinally and oral epithelial cells taken longitudinally for each patient included, with each patient included, with the corresponding clinical data. An oral epithelial cell sample will be collected at inclusion from 2 swabs, which will allow extraction of DNA from healthy from healthy cells. During blood sampling necessary for care, an additional 40 ml of blood will be collected of 40 ml of blood will be collected in 10 tubes of 4 ml: 4 EDTA tubes, 4 heparinized heparinized tubes and 2 dry tubes. These additional collections will take place at the following times:
- At inclusion
- 7 days (+/- 2 days) after initiation of treatment
- 14 days (+/- 2 days) after initiation of therapy
- 21-42 days after initiation of therapy (early response assessment)
- In case of complete remission
- In case of relapse or progression During bone marrow punctures required for treatment, 6 ml of bone marrow bone marrow will be collected in 2 tubes of 3 ml: 1 EDTA tube and 1 heparinized tube. heparinized tube. These additional collections will take place at the following times following times:
- At inclusion
- 21-42 days after initiation of treatment (assessment of early response) early response)
- In case of complete remission
- In case of relapse or progression Patients will be followed for up to 2 years after inclusion.
- Conditions
- Hematologic Cancer
- Being tested
- experimental:Acute leukemia/myelodysplastic or myeloproliferative disease
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental:Acute leukemia/myelodysplastic or myeloproliferative diseaseOther
blood sampling, bone marrow aspirate and buccal swab
| Study group | Role | What they receive |
|---|---|---|
| experimental:Acute leukemia/myelodysplastic or myeloproliferative disease | Experimental | blood sampling, bone marrow aspirate, and buccal swab Receives: Other: experimental:Acute leukemia/myelodysplastic or myeloproliferative disease |
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)
establishment of genomic and proteomic signatures as well as transcriptomic and metabolic profiles associated with IT resistance.
Measured: up to 7 years
Secondary outcomes (2)
to study the resistance to treatments
study of the sensitivity to IT in vitro of primary cells from patients
Measured: up to 7 years
Creation of murine cell models (Patient-derived xenografts, PDX) from patient blasts to study in vivo in order to study in vivo the mechanisms of resistance to treatment.
Establishment of xenografts in immunocompromised mice from primary cells of TI-resistant patients patients resistant to IT
Measured: up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study startJan 2023 (estimated)
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic CancerStudies 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
- Model description
- the study is interventional because there are blood samples taken outside the scope of routine care
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602168
- Sponsor's protocol ID
- HEMATOBIO.02-IPC 2021-061
- Status last verified
- Oct 2022
- First submitted
- 10 Oct 2022
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collection of Sequential Samples From Patients With Malignant Myeloid Hemopathy for the Study of Treatment Resistance: HEMATOBIO.02-IPC 2021-061
- ClinicalTrials.gov ID
- NCT05602168
- Acronym / sponsor ID
- HEMATOBIO.02-IPC 2021-061
- Conditions
- Hematologic Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 1 Nov 2022 (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.
The main objective is to study the genomic, transcriptomic, proteomic epigenomic, metabolomic and immune mechanisms of blasts and microenvironment cells associated with IT resistance through the constitution of a collection associating blood or marrow samples from patients with LA, MDS and MPS marrow samples from patients with LA, MDS and MPS at diagnosis, during treatment and at relapse and relapse and clinical annotations.
Detailed description
It is a collection of blood, marrow and oral epithelial cell samples taken longitudinally and oral epithelial cells taken longitudinally for each patient included, with each patient included, with the corresponding clinical data. An oral epithelial cell sample will be collected at inclusion from 2 swabs, which will allow extraction of DNA from healthy from healthy cells. During blood sampling necessary for care, an additional 40 ml of blood will be collected of 40 ml of blood will be collected in 10 tubes of 4 ml: 4 EDTA tubes, 4 heparinized heparinized tubes and 2 dry tubes. These additional collections will take place at the following times:
- At inclusion
- 7 days (+/- 2 days) after initiation of treatment
- 14 days (+/- 2 days) after initiation of therapy
- 21-42 days after initiation of therapy (early response assessment)
- In case of complete remission
- In case of relapse or progression During bone marrow punctures required for treatment, 6 ml of bone marrow bone marrow will be collected in 2 tubes of 3 ml: 1 EDTA tube and 1 heparinized tube. heparinized tube. These additional collections will take place at the following times following times:
- At inclusion
- 21-42 days after initiation of treatment (assessment of early response) early response)
- In case of complete remission
- In case of relapse or progression Patients will be followed for up to 2 years after inclusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- the study is interventional because there are blood samples taken outside the scope of routine care
| Arm | Type | Receives |
|---|---|---|
| experimental:Acute leukemia/myelodysplastic or myeloproliferative disease | Experimental | Other: experimental:Acute leukemia/myelodysplastic or myeloproliferative diseaseblood sampling, bone marrow aspirate, and buccal swab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of acute leukemia, myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML) or myeloproliferative syndrome according to the WHO classification 2016,
- Patient for whom a new line of therapy is initiated.
- Patient older than 18 years of age.
- Patient affiliated to the social security system or benefiting from such a system.
- Signed consent to participate.
Key exclusion criteria (5 listed)
- Weight at inclusion < 50 kg
- Participating in another clinical study that would cause the total amount of blood collection to exceed the and endanger the patient
- Person in an emergency situation, adult under legal protection (guardianship, curatorship, etc.) protection (guardianship, curatorship or safeguard of justice), or unable to express his or her consent.
- Impossibility to submit to the medical follow-up of the trial for geographical social or psychological reasons,
- Pregnant or breastfeeding women
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 |
|---|---|---|
| experimental:Acute leukemia/myelodysplastic or myeloproliferative diseaseblood sampling, bone marrow aspirate and buccal swab | Other | experimental: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 7 years
establishment of genomic and proteomic signatures as well as transcriptomic and metabolic profiles associated with IT resistance.
2 secondary outcomes
to study the resistance to treatments
Time frame: up to 7 years
Creation of murine cell models (Patient-derived xenografts, PDX) from patient blasts to study in vivo in order to study in vivo the mechanisms of resistance to treatment.
Time frame: up to 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 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.
Questions about this trial
What is this clinical trial studying?
A study testing experimental:Acute leukemia/myelodysplastic or myeloproliferative disease in people with Hematologic Cancer, run by Institut Paoli-Calmettes.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominique GENRE, MD (+33491223778, drci.up@ipc.unicancer.fr), or a site near the patient. 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 7 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 1 Nov 2022.