Acute Myeloid LeucemiaSCALANCT06906978
Single Cell Acute Leukemia Analysis
A study testing blood sampling in people with Acute Myeloid Leucemia, run by Assistance Publique Hopitaux De Marseille.
Trial summary
Numerous chemotherapy and immunotherapy resistance genes have been identified in cancers in general and acute myeloid leukemia in particular. As a preliminary to this study, the investigators hypothesized the co-expression of these genes in the same cell as a major factor in relapse. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leucemia
- What is being tested?
- blood sampling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 31 Jul 2025to 31 Jul 2029
- 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
- Adult patient
- Patient who has received information about the study and has not expressed opposition,
- Patients who are beneficiaries of a social security plan,
- Patient with relapsed or refractory acute myeloid leukemia, whatever the previous treatment, the therapeutic line and the time between the previous treatment and the relapse.
Who cannot join
- Persons who do not understand the French language if there is no translator available to translate for them.
- Absence of circulating blastosis.
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
Numerous chemotherapy and immunotherapy resistance genes have been identified in cancers in general and acute myeloid leukemia in particular. As a preliminary to this study, the investigators hypothesized the co-expression of these genes in the same cell as a major factor in relapse. This hypothesis was supported in vitro by the study of the evolution of these co-expressions after incubation with chemotherapy drugs. The current study aims to verify this hypothesis by studying the expression of these genes in single-cell samples from relapsed acute myeloid leukemia patients.
- Conditions
- Acute Myeloid Leucemia
- Being tested
- blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingProcedure or surgery
Patients will be seen in hospital as part of their routine care, during which a blood test will be prescribed. On this occasion, an additional 20 mlof blood will be collected for research purposes.
| Study group | Role | What they receive |
|---|---|---|
| Patient with acute myeloid leukemia | Other | Adult patient with acute myeloid for whom an additionnal 20 mL of blood will be collected. Receives: Procedure: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of leukemic blasts coexpressing P-glycoprotein (PGP)-Multidrug resistance-related protein (MRP)+ Glutathione S-transferase (GST)+ anti- B-cell Lymphoma 2 (BLC2)
Preliminary in vitro data show that the percentage of blasts coexpressing PGP+MRP+GST+BCL2 is 15% after in vitro chemotherapy. To verify these data in relapsed/refractory patients, the investigators will evaluate the percentage of patients with in vivo leukemic blasts coexpressing PGP+MRP+GST+BCL2 at >15% post-chemotherapy.
Measured: 36 months
Secondary outcomes (1)
percentage of P-glycoprotein (PGP)-Multidrug resistance-related protein (MRP)+ Glutathione S-transferase (GST)+ anti- B-cell Lymphoma 2 (BLC2) coexpression in leukemic blasts
Mean percentages of PGP+MRP+GST+BCL2 co-expression in leukemic blasts from patients with relapsed or refractory acute myeloid leukemia.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start31 Jul 2025 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeucemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Régis Costello, Professor, Principal investigator, Assitance Public - Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906978
- Sponsor's protocol ID
- RCAPHM25_0039
- Other IDs
- 2025-A00734-45.
- Acronym
- SCALA
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Cell Acute Leukemia Analysis
- ClinicalTrials.gov ID
- NCT06906978
- Acronym / sponsor ID
- SCALA / RCAPHM25_0039
- Conditions
- Acute Myeloid Leucemia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 31 Jul 2025 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 2 Apr 2025 (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.
Numerous chemotherapy and immunotherapy resistance genes have been identified in cancers in general and acute myeloid leukemia in particular. As a preliminary to this study, the investigators hypothesized the co-expression of these genes in the same cell as a major factor in relapse. This hypothesis was supported in vitro by the study of the evolution of these co-expressions after incubation with chemotherapy drugs. The current study aims to verify this hypothesis by studying the expression of these genes in single-cell samples from relapsed acute myeloid leukemia patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with acute myeloid leukemia | Other | Procedure: blood samplingAdult patient with acute myeloid for whom an additionnal 20 mL of blood will be collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient
- Patient who has received information about the study and has not expressed opposition,
- Patients who are beneficiaries of a social security plan,
- Patient with relapsed or refractory acute myeloid leukemia, whatever the previous treatment, the therapeutic line and the time between the previous treatment and the relapse.
Key exclusion criteria (2 listed)
- Persons who do not understand the French language if there is no translator available to translate for them.
- Absence of circulating blastosis.
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 samplingPatients will be seen in hospital as part of their routine care, during which a blood test will be prescribed. On this occasion, an additional 20 mlof blood will be collected for research purposes. | Procedure or surgery | Patient with acute myeloid leukemia |
Primary outcome
percentage of leukemic blasts coexpressing P-glycoprotein (PGP)-Multidrug resistance-related protein (MRP)+ Glutathione S-transferase (GST)+ anti- B-cell Lymphoma 2 (BLC2)
Time frame: 36 months
Preliminary in vitro data show that the percentage of blasts coexpressing PGP+MRP+GST+BCL2 is 15% after in vitro chemotherapy. To verify these data in relapsed/refractory patients, the investigators will evaluate the percentage of patients with in vivo leukemic blasts coexpressing PGP+MRP+GST+BCL2 at >15% post-chemotherapy.
1 secondary outcome
percentage of P-glycoprotein (PGP)-Multidrug resistance-related protein (MRP)+ Glutathione S-transferase (GST)+ anti- B-cell Lymphoma 2 (BLC2) coexpression in leukemic blasts
Time frame: 36 months
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 10 Apr 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Myeloid Leucemia
Recruiting
This Study Aims to Improve the Stratification of Patients With Acute Myeloid Leukemia to Enable More Personalized and Effective Treatments, and to Identify and Functionally Validate, at the Single-cell Level, Biomarkers That Can Predict Response to Venetoclax.
Acute Myeloid Leukemia
RecruitingObservational study
Creation of a Biocollection of Patients With Acute Myeloid Leukemia (AML) or Lymphoid Leukemia (ALL) or High-risk Myelodysplastic Syndrome (MDS) Monitored at the Nantes University Hospital
Acute Myeloid Leucemia, High-risk Myelodysplastic Syndrome (MDS)
RecruitingPhase 3
Fludarabine Plus Melphalan Versus Addition of Venetoclax to Fludarabine/Melphalan Conditioning Regimen for Allogeneic Hematopoietic Stem Cell Transplantation in AML/MDS Patients Aged > 50 Years: a Multicenter, Randomized, Phase 3 Trial
Venentoclax, Myeloid Malignancies
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.
Régis Costello, Professor principal investigator
Assitance Public - Hôpitaux de Marseille
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Acute Myeloid Leucemia, run by Assistance Publique Hopitaux De Marseille.
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: opening soon, as of the sponsor's last update on 10 Apr 2025. 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 clement PIERRE, PhD (+33491435796, clement.pierre@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of leukemic blasts coexpressing P-glycoprotein (PGP)-Multidrug resistance-related protein (MRP)+ Glutathione S-transferase (GST)+ anti- B-cell Lymphoma 2 (BLC2) (time frame: 36 months). 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 10 Apr 2025.