Acute Myeloid Leukemia (AML)ARISE-AMLNCT06709235
Assessing Refractoriness and Infectious Survival Events in AML
An observational study of Acute Myeloid Leukemia (AML), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Despite therapeutic advance in acute myeloid leukemia (AML), the prognosis remains poor, with an overall survival (OS) of 30% at 5 years [1, 2]. Treatment of 1st-line AML in patients under 75 years of age is based on intensive chemotherapy (IC) followed by allogeneic transplantation (hematopoietic stem cell… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2024to 30 Jul 2024
- Phase
- Observational
- 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
Study population: Patients with an AML diagnosis during the screening period (01/01/2015 and 31/12/2021) receiving intensive chemotherapy and evaluable at the end of induction phase.
Who may be able to join
- Patients with acute myeloid leukemia (AML)
- Age over 18 years
- Treatment with "intensive" chemotherapy (combination of aracytin and an anthracycline)
- Date of diagnosis of acute myeloid leukemia between 01/01/2015 and 31/12/2021
- Treatment received at Hospices Civils de Lyon (HCL)
Who cannot join
- Patients with acute promyelocytic leukemia (AML 3)
- Treatment with "non-intensive" chemotherapy (i.e. azacytidine)
- Death before first post-chemotherapy bone marrow assessment
- No computerized data available
- Follow-up at a center other than HCL
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Characterization of Infectious Events and Their Impact on Survival in Patients with Acute Myeloid Leukemia Treated with Intensive Chemotherapy
Despite therapeutic advance in acute myeloid leukemia (AML), the prognosis remains poor, with an overall survival (OS) of 30% at 5 years [1, 2]. Treatment of 1st-line AML in patients under 75 years of age is based on intensive chemotherapy (IC) followed by allogeneic transplantation (hematopoietic stem cell transplantation, HSCT) [3]. Following its administration, a phase known as aplasia ensues, during which patients are severely immunocompromised. This period of aplasia therefore carries a very high risk of infectious events, despite management in protected areas and infectious prophylaxis. Infectious problems remain one of the leading causes of mortality in the initial phase of AML treatment [4]. The incidence of sepsis, the microorganisms involved and the complications arising from infectious episodes during chemotherapy remain poorly described, as do their long-term prognostic consequences for these patients [5,6].
Moreover, there is a "dogma" among hematologists dealing specifically with AML that intensive chemotherapy during which there are no infectious events is often a sign of non-response. Although this "popular" belief has never been verified prospectively or even retrospectively, it is based on the observation of many generations of clinicians. This belief suggests that immune stimulation during aplasie could promote remission by inducing an anti-leukemic immune response. Furthermore, numerous cases of "spontaneous" remission (i.e. in AML patients receiving no active treatment) following infections or highly immune-stimulating events have been reported in the literature [7-10].
Read more
It might therefore be hypothesized that infectious events occurring during the post-intensive chemotherapy aplasia phase for AML could favor the achievement of remission by nonspecific immune stimulation.
The aim of this study is to describe the incidence and type of septic episodes occurring in patients undergoing intensive treatment for acute myeloid leukemia, and to assess the impact of these episodes on patient prognosis, notably via the risk of relapse and long-term survival.
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute myeloid leukemia, infections, intensive chemotherapy, survival
- Medical subject headings
- Leukemia, Myeloid, Acute, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AML patients treated with intensive chemotherapy | Patients diagnosed with acute myeloid leukemia treated in our center with 3+7 based induction chemotherapy regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the incidence, nature and complications engendered by the occurrence of infectious events during intensive management for AML.
Analysis of the number, type, and complications of infectious events observed during the induction and consolidation phases of intensive management for AML.
Measured: through study completion, during 3 mounths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 May 2024
- Primary completion1 May 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 280 participants (actual)
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
- NCT06709235
- Sponsor's protocol ID
- 23-5053
- Acronym
- ARISE-AML
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Infectious Events and Their Impact on Survival in Patients with Acute Myeloid Leukemia Treated with Intensive Chemotherapy
- ClinicalTrials.gov ID
- NCT06709235
- Acronym / sponsor ID
- ARISE-AML / 23-5053
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- Acute myeloid leukemia, infections, intensive chemotherapy, survival
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 29 Nov 2024 (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.
Despite therapeutic advance in acute myeloid leukemia (AML), the prognosis remains poor, with an overall survival (OS) of 30% at 5 years [1, 2]. Treatment of 1st-line AML in patients under 75 years of age is based on intensive chemotherapy (IC) followed by allogeneic transplantation (hematopoietic stem cell transplantation, HSCT) [3]. Following its administration, a phase known as aplasia ensues, during which patients are severely immunocompromised. This period of aplasia therefore carries a very high risk of infectious events, despite management in protected areas and infectious prophylaxis. Infectious problems remain one of the leading causes of mortality in the initial phase of AML treatment [4]. The incidence of sepsis, the microorganisms involved and the complications arising from infectious episodes during chemotherapy remain poorly described, as do their long-term prognostic consequences for these patients [5,6].
Moreover, there is a "dogma" among hematologists dealing specifically with AML that intensive chemotherapy during which there are no infectious events is often a sign of non-response. Although this "popular" belief has never been verified prospectively or even retrospectively, it is based on the observation of many generations of clinicians. This belief suggests that immune stimulation during aplasie could promote remission by inducing an anti-leukemic immune response. Furthermore, numerous cases of "spontaneous" remission (i.e. in AML patients receiving no active treatment) following infections or highly immune-stimulating events have been reported in the literature [7-10].
It might therefore be hypothesized that infectious events occurring during the post-intensive chemotherapy aplasia phase for AML could favor the achievement of remission by nonspecific immune stimulation.
The aim of this study is to describe the incidence and type of septic episodes occurring in patients undergoing intensive treatment for acute myeloid leukemia, and to assess the impact of these episodes on patient prognosis, notably via the risk of relapse and long-term survival.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AML patients treated with intensive chemotherapy | – | –Patients diagnosed with acute myeloid leukemia treated in our center with 3+7 based induction chemotherapy regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an AML diagnosis during the screening period (01/01/2015 and 31/12/2021) receiving intensive chemotherapy and evaluable at the end of induction phase.
Key inclusion criteria (5 listed)
- Patients with acute myeloid leukemia (AML)
- Age over 18 years
- Treatment with "intensive" chemotherapy (combination of aracytin and an anthracycline)
- Date of diagnosis of acute myeloid leukemia between 01/01/2015 and 31/12/2021
- Treatment received at Hospices Civils de Lyon (HCL)
Key exclusion criteria (5 listed)
- Patients with acute promyelocytic leukemia (AML 3)
- Treatment with "non-intensive" chemotherapy (i.e. azacytidine)
- Death before first post-chemotherapy bone marrow assessment
- No computerized data available
- Follow-up at a center other than HCL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the incidence, nature and complications engendered by the occurrence of infectious events during intensive management for AML.
Time frame: through study completion, during 3 mounths
Analysis of the number, type, and complications of infectious events observed during the induction and consolidation phases of intensive management for AML.
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 29 Nov 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 (AML), run by Hospices Civils de Lyon 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 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: finished, as of the sponsor's last update on 29 Nov 2024. 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?
Description of the incidence, nature and complications engendered by the occurrence of infectious events during intensive management for AML. (time frame: through study completion, during 3 mounths). 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 29 Nov 2024.