Acute Myeloid LeukemiaeTHEMANCT05326919
The Patient Cohort of the National Center for Precision Medicine in Leukemia
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
If for years the treatment strategy of leukemia and related disorders (LRDs, including acute leukemias and predisposition syndromes) has been based solely on whether the patient could receive or not intensive chemotherapy and transplantation, the advent of new targeted or less targeted drugs has led to the development… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome
- What is being tested?
- Biobanking
- How many people
- 3,000 participants
- Where
- 3 sitesFrance
- Study dates
- 28 Mar 2022to Mar 2042
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with newly diagnosed acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or myeloproliferative neoplasm (MPN)-related myelofibrosis, when managed and treated according to standard diagnosis and care practices
Who may be able to join
- Patient with newly diagnosed previously untreated de novo, secondary or therapy-related leukemia or related disorders (LRD), including AML, ALL, HR-MDS (according to the international score IPSS), and MNP-related myelofibrosis
- Patient informed and not opposed to participating
- Affiliation to social security or any health insurance
Who cannot join
- LRD which is not morphologically proven (patients with granulocytic sarcoma may be included)
- Previous treatment for LRD, apart from:
- Hydroxyurea or previous MDS/MPN-CML therapy in AML patients
- Steroids, vincristine, intrathecal prophylactic or curative injection or previous CML therapy in ALL patients
- Erythroid stimulating agents (ESAs), luspatercept, granulocyte colony-stimulating factor (G-CSF), eltrombopag or other TPO agonist, iron chelation therapy, hypomethylating agents (HMAs), lenalidomide or any investigational drug previously used to treat MDS in HR-MDS patients
- Hydroxyurea, standard or pegylated interferon alpha, ruxolitinib or other JAK inhibitors, busulfan, anagrelide, ESAs or any investigational drug previously used to treat MPN in MPN-related myelofibrosis patients
Show all 9Show fewer
- Patient under guardianship / curatorship
- Patient under AME
- Opposition of the patient to be enrolled in the eTHEMA cohort
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
Hôpital Avicenne
Bobigny
Thorsten Braun, Pr, thorsten.braun@aphp.fr
- Recruiting
Hopital Robert Debré
Paris
André Baruchel, Pr, andre.baruchel@aphp.fr
- Recruiting
Hôpital Saint Louis
Paris
Hervé Dombret, Pr, 1 57 27 68 47 ext. +33, herve.dombret@aphp.fr
About this study
If for years the treatment strategy of leukemia and related disorders (LRDs, including acute leukemias and predisposition syndromes) has been based solely on whether the patient could receive or not intensive chemotherapy and transplantation, the advent of new targeted or less targeted drugs has led to the development of a growing number of new therapeutic approaches, very often offered to specific patient/disease subsets, justifying the generic term of 'precision medicine'.
As an international leukemia center of excellence, THEMA, the French National Center for Precision Medicine in Leukemia (selected as IHUB-2 by the French National Agency for Research), is a care, research, transfer and education initiative located at the Saint-Louis Research Institute (IRSL) in Paris and devoted to precision medicine in leukemia in a real-life environment.
Read more
The present non-interventional study (eTHEMA) is a pillar of the whole THEMA project. As a prerequisite for precision medicine, this program focuses on individual data collection, aiming to collect high-quality data not only in patients treated into prospective clinical trials, but in every THEMA patient with a special interest in outpatients' care and research.
The primary objective of this non-interventional study is to describe the baseline characteristics planned treatments and outcomes of patients newly diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or myeloproliferative neoplasm (MPN)-related myelofibrosis, when managed and treated according to standard diagnosis and care practices.
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome, Secondary Myelofibrosis in Myeloproliferative Disease, Myeloproliferative Neoplasm, Unclassifiable
- Being tested
- Biobanking
- Medical subject headings
- Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiobankingOther
For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored.
| Study group | Role | What they receive |
|---|---|---|
| Acute myeloid Leukemia (AML) | Standard and routine care.
For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored. Receives: Other: Biobanking | |
| Acute lymphoblastic leukemia (ALL) | Standard and routine care.
For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored. Receives: Other: Biobanking | |
| High-risk myelodysplastic syndrome (MDS) | Standard and routine care.
For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored. Receives: Other: Biobanking | |
| Myeloproliferative neoplasm -related myelofibrosis | Standard and routine care.
For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored. Receives: Other: Biobanking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event Free Survival
Measured: at 5 years
Relapse Free Survival
Measured: at 5 years
Overall Survival
Measured: at 5 years
Secondary outcomes (32)
Standardized evaluation of hematological response
Measured: After induction cycle which is between between day 25 and day 42 for patients treated intensively and between Month 1 and Month 6 for patients treated treated with low intensity regimen
Standardized evaluation of hematological response
Measured: After first consolidation cycle which is between 1 and 2 months
Standardized evaluation of hematological response
Measured: After last consolidation cycle which is between 3 and 8 months
Standardized evaluation of hematological response
Measured: Before HSCT
Standardized evaluation of hematological response
Measured: at day 100 after HSCT
Standardized evaluation of hematological response
Measured: at 5 years
Minimal measurable residual disease (MRD) response
Measured: After induction which is between day 25 and day 42 for patients treated intensively and between month 1 and month 6 for patients with low intensity regimen
Minimal measurable residual disease (MRD) response
Measured: After first consolidation cycle which is between 1 and 2 months
Minimal measurable residual disease (MRD) response
Measured: After last consolidation cycle which is between 3 and 8 months
Minimal measurable residual disease (MRD) response
Measured: Before HSCT
Minimal measurable residual disease (MRD) response
Measured: at day 100 after HSCT
Minimal measurable residual disease (MRD) response
Measured: at 5 years
Incidence of allogeneic HSCT
Measured: at 5 years
Modalities of allogeneic HSCT
Measured: at 5 years
Incidence of hematological relapses
Measured: at 5 years
Type of hematological relapses
Measured: at 5 years
Incidence of hematological progressions
Measured: at 5 years
Type of hematological progressions
Measured: at 5 years
Incidence of MRD relapses
Measured: at 5 years
Incidence of MRD progressions
Measured: at 5 years
Proportions of patients with treatment-related toxicities
Treatment-related toxicities will be Evaluated by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Measured: at 5 years
Cumulative incidences of relapse
Measured: at 5 years
Cumulative incidences of non-relapse mortality
Measured: at 5 years
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: at inclusion
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality-of-life will be assessed using the EORTC-QLQ-C30 v3 questionnaire.Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: at the end of induction which is between day 25 and day 42 for patients treated intensively and between month 1 and month 6 for patients with low intensity regimen
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality-of-life will be assessed using the EORTC-QLQ-C30 v3 questionnaire. Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: after 2 consolidations courses which is between 3 months and 8 months
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality-of-life will be assessed using the EORTC-QLQ-C30 v3 questionnaire. Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: at 3 months after the end of treatment
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality-of-life will be assessed using the EORTC-QLQ-C30 v3 questionnaire. Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: at 6 months after the end of treatment
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality-of-life will be assessed using the EORTC-QLQ-C30 v3 questionnaire. Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: at 12 months after the end of treatment
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Quality-of-life will be assessed using the EORTC-QLQ-C30 v3 questionnaire. Quality of life evaluated using questionnaire "European Organization for Research and Treatment of Cancer Quality of Life Questionnaire" (EORTC QLQ-C30- v3). The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. A high score for a functional scale represents a high/healthy level of functioning. A high score for the global health status/ QoL represents a high QoL and a high score for a symptom scale/item represents a high level of symptomatology/problems.
Measured: at day 100 after hematopoietic stem cell transplant
Incidence of secondary cancer
Measured: at 5 years
Incidence of secondary cancer
Measured: up to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start28 Mar 2022
- Primary completionMar 2042 (estimated)
- Study completionMar 2042 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326919
- Sponsor's protocol ID
- APHP210850
- Acronym
- eTHEMA
- Status last verified
- May 2024
- First submitted
- 28 Jan 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Zhao LP, Dumas-Rivero T, Barette L, Aguinaga L, Cheffai A, Chauvel C, Dal Bello R, Raffoux E, Clappier E, Duchmann M, Fenaux P, Lemaire P, Mathis S, Sebert M, Ades L, Itzykson R. Prognostic significance of monocytic-like phenotype in patients with AML treated with venetoclax and azacytidine. Blood Adv. 2025 Jul 22;9(14):3556-3565. doi: 10.1182/bloodadvances.2024015734.
PubMed 40249917
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Patient Cohort of the National Center for Precision Medicine in Leukemia
- ClinicalTrials.gov ID
- NCT05326919
- Acronym / sponsor ID
- eTHEMA / APHP210850
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, High-risk Myelodysplastic Syndrome, Secondary Myelofibrosis in Myeloproliferative Disease, Myeloproliferative Neoplasm, Unclassifiable
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- Mar 2042 (estimated)
- Study completion
- Mar 2042 (estimated)
- First posted
- 14 Apr 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.
If for years the treatment strategy of leukemia and related disorders (LRDs, including acute leukemias and predisposition syndromes) has been based solely on whether the patient could receive or not intensive chemotherapy and transplantation, the advent of new targeted or less targeted drugs has led to the development of a growing number of new therapeutic approaches, very often offered to specific patient/disease subsets, justifying the generic term of 'precision medicine'.
As an international leukemia center of excellence, THEMA, the French National Center for Precision Medicine in Leukemia (selected as IHUB-2 by the French National Agency for Research), is a care, research, transfer and education initiative located at the Saint-Louis Research Institute (IRSL) in Paris and devoted to precision medicine in leukemia in a real-life environment.
The present non-interventional study (eTHEMA) is a pillar of the whole THEMA project. As a prerequisite for precision medicine, this program focuses on individual data collection, aiming to collect high-quality data not only in patients treated into prospective clinical trials, but in every THEMA patient with a special interest in outpatients' care and research.
The primary objective of this non-interventional study is to describe the baseline characteristics planned treatments and outcomes of patients newly diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or myeloproliferative neoplasm (MPN)-related myelofibrosis, when managed and treated according to standard diagnosis and care practices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acute myeloid Leukemia (AML) | – | Other: BiobankingStandard and routine care. For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored. |
| Acute lymphoblastic leukemia (ALL) | – | Other: BiobankingStandard and routine care. For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored. |
| High-risk myelodysplastic syndrome (MDS) | – | Other: BiobankingStandard and routine care. For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored. |
| Myeloproliferative neoplasm -related myelofibrosis | – | Other: BiobankingStandard and routine care. For storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with newly diagnosed acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or myeloproliferative neoplasm (MPN)-related myelofibrosis, when managed and treated according to standard diagnosis and care practices
Key inclusion criteria (3 listed)
- Patient with newly diagnosed previously untreated de novo, secondary or therapy-related leukemia or related disorders (LRD), including AML, ALL, HR-MDS (according to the international score IPSS), and MNP-related myelofibrosis
- Patient informed and not opposed to participating
- Affiliation to social security or any health insurance
Key exclusion criteria (9 listed)
- LRD which is not morphologically proven (patients with granulocytic sarcoma may be included)
- Previous treatment for LRD, apart from:
- Patient under guardianship / curatorship
- Patient under AME
- Opposition of the patient to be enrolled in the eTHEMA cohort
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 |
|---|---|---|
| BiobankingFor storage,limited volumes of blood or bone marrow aspirate will be added to usual sampling and stored. | Other | Acute lymphoblastic leukemia (ALL), Acute myeloid Leukemia (AML), High-risk myelodysplastic syndrome (MDS), Myeloproliferative neoplasm -related myelofibrosis |
Primary outcome
Event Free Survival
Time frame: at 5 years
Relapse Free Survival
Time frame: at 5 years
Overall Survival
Time frame: at 5 years
32 secondary outcomes
Standardized evaluation of hematological response
Time frame: After induction cycle which is between between day 25 and day 42 for patients treated intensively and between Month 1 and Month 6 for patients treated treated with low intensity regimen
Standardized evaluation of hematological response
Time frame: After first consolidation cycle which is between 1 and 2 months
Standardized evaluation of hematological response
Time frame: After last consolidation cycle which is between 3 and 8 months
Standardized evaluation of hematological response
Time frame: Before HSCT
Standardized evaluation of hematological response
Time frame: at day 100 after HSCT
Standardized evaluation of hematological response
Time frame: at 5 years
Minimal measurable residual disease (MRD) response
Time frame: After induction which is between day 25 and day 42 for patients treated intensively and between month 1 and month 6 for patients with low intensity regimen
Minimal measurable residual disease (MRD) response
Time frame: After first consolidation cycle which is between 1 and 2 months
Minimal measurable residual disease (MRD) response
Time frame: After last consolidation cycle which is between 3 and 8 months
Minimal measurable residual disease (MRD) response
Time frame: Before HSCT
Minimal measurable residual disease (MRD) response
Time frame: at day 100 after HSCT
Minimal measurable residual disease (MRD) response
Time frame: at 5 years
Incidence of allogeneic HSCT
Time frame: at 5 years
Modalities of allogeneic HSCT
Time frame: at 5 years
Incidence of hematological relapses
Time frame: at 5 years
Type of hematological relapses
Time frame: at 5 years
Incidence of hematological progressions
Time frame: at 5 years
Type of hematological progressions
Time frame: at 5 years
Incidence of MRD relapses
Time frame: at 5 years
Incidence of MRD progressions
Time frame: at 5 years
Proportions of patients with treatment-related toxicities
Time frame: at 5 years
Cumulative incidences of relapse
Time frame: at 5 years
Cumulative incidences of non-relapse mortality
Time frame: at 5 years
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Time frame: at inclusion
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Time frame: at the end of induction which is between day 25 and day 42 for patients treated intensively and between month 1 and month 6 for patients with low intensity regimen
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Time frame: after 2 consolidations courses which is between 3 months and 8 months
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Time frame: at 3 months after the end of treatment
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Time frame: at 6 months after the end of treatment
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Time frame: at 12 months after the end of treatment
Quality-of-life assessed using the EORTC-QLQ-C30 v3 questionnaire
Time frame: at day 100 after hematopoietic stem cell transplant
Incidence of secondary cancer
Time frame: at 5 years
Incidence of secondary cancer
Time frame: up to 15 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 29 May 2024.
- Derived from this study: PubMed 40249917Zhao LP, Dumas-Rivero T, Barette L, Aguinaga L, Cheffai A, Chauvel C, Dal Bello R, Raffoux E, Clappier E, Duchmann M, Fenaux P, Lemaire P, Mathis S, Sebert M, Ades L, Itzykson R. Prognostic significance of monocytic-like phenotype in patients with AML treated with venetoclax and azacytidine. Blood Adv. 2025 Jul 22;9(14):3556-3565. doi: 10.1182/bloodadvances.2024015734.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia, run by Assistance Publique - Hôpitaux de Paris at 3 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 9 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: looking for participants now, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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 Hervé DOMBRET, Pr (1 57 27 68 47 ext. +33, herve.dombret@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event Free Survival (time frame: at 5 years). The study lists 3 primary outcomes in all. 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 NCT05326919, which also lists 1 linked publication.
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 29 May 2024.