Acute Myeloid LeukemiaDECLAMNCT03450512
Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy
An observational study of Acute Myeloid Leukemia, run by Centre Hospitalier Universitaire, Amiens at 3 sites in France.
Trial summary
Neutropenia after induction or consolidation therapy for acute myeloid leukemia (AML) patients is associated with a high morbi-mortality rates, especially due to infectious complications. These are managed according to international recommandations (ECIL and IDSA) with antibiotherapy and antifungal strategy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- prospective study on digestive affections in an homogeneous cohort of hematological patients
- Type of treatment
- Injection or infusion
- How many people
- 170 participants
- Where
- 3 sitesFrance
- Study dates
- 14 Jan 2019to 13 Nov 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 febrile neutropenia after induction or consolidation courses for AML( acute myeloid leukemia ).
Who may be able to join
- Age > 18 years
- Every patient of hematology:
- Able to receive an intensive treatment for AML (induction then intensive consolidations) causing a neutropenia with high infectious risk
- In state to give its consent
- Affiliated to a social security system
Who cannot join
- The minor patients
- The patients affected by AML not being able to receive an intensive therapy
- The patients affected by acute promyelocytic leukaemia
- The pregnant women
- The patients with HIV, hepatitis B or C
- The patients under guardianship or guardianship or deprived of freedom by a court or administrative order (according to articles L1121-6 and L1121-8 of the Public health code)
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
CHU Amiens-Picardie
Amiens, 80000
Delphine LEBON, Ph, lebon.delphine@chu-amiens.fr
Delphine LEBON, Ph
- Not yet recruiting
CHU de Caen
Caen, 14033
Sylvain CHANTEPIE, PhD
Sylvain CHANTEPIE, PhD
- Recruiting
Henri Becquerel Center
Rouen, 76038
Fabrince JARDIN, PhD
Fabrice JARDIN
About this study
Official title: Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy (DECLAM).
Neutropenia after induction or consolidation therapy for acute myeloid leukemia (AML) patients is associated with a high morbi-mortality rates, especially due to infectious complications. These are managed according to international recommandations (ECIL and IDSA) with antibiotherapy and antifungal strategy. Although the patients suffer of digestive symptoms, intestinale complications are really less explored. Neutropenic enterocolitis (NE), cytomegalovirus (CMV) colitis, Clostridium difficile colitis, specific lesion, ischemic colitis are not well-known. No prospective study evaluate NE and these digestive complications which have high morbi-mortality rates.
Read the detailed description
This is the first prospective study on digestive affections in an homogeneous cohort of hematological patients. These affections are unknown in neutropenic patients with digestive symptoms after induction or consolidation courses pour AML although causing high morbi-mortality rates (infections, denutrition, loss of autonomy…).
The aim of the study is to evaluate incidence of NE by clinical signs and with a systematic CT scan performed at day 5 of fever during aplastic period. An early diagnostic could decrease complications and evaluate gravity criteria which could imply surgery therapy.
The physician will performe a CTscan with injection during the induction and/or every consolidation, at the same time as the thoracic CTscan (to research an invasive fungal bronchopulmonary infection), in front of a febrile neutropenia with persistent fever after 5 days of antibiotics and presence of digestive signs.
The clinical, microbiological, radiological symptoms will be registered at every time of febrile neutropenia with digestive symptoms at induction and each consolidation courses. The patient will be get out of the study when the AML is refractory, hematopoietic stem cell transplantation is required or if whenever he want. The last visit will be at the end of consolidation courses.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- prospective study on digestive affections in an homogeneous cohort of hematological patients
- Keywords
- Neutropenic enterocolitis, Acute myeloid leukemia, Abdominal tomodensitometry
- Medical subject headings
- Leukemia, Myeloid, Acute, Enterocolitis, Neutropenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prospective study on digestive affections in an homogeneous cohort of hematological patientsOther
Systematic realization during the induction and/or every consolidation of a CTscan with injection, at the same time as the thoracic CTscan (to research an invasive fungal bronchopulmonary infection), in front of a febrile neutropenia with persistent fever after 5 days of antibiotics and presence of digestive signs.
Statement of the information characterizing the digestive affection: clinical symptoms, microbiological, characteristic, realized additional explorations, infectious complications and specific therapeutics.
The abdominal scanner will be repeated in case of suspicion of complication or clinical worsening. In case of EC, the abdominal scanner will be realized before beginning the next cycle of AML treatment to evaluate digestive remission. Finally, a CT scan, will be performed when digestive disease, digestive neoplasia or digestive symptoms are noted at AML diagnosis.
What is being measured
The primary outcome is the main question the study is designed to answer.
the arisen of EC in the CT scan
The main assessment criteria is the arisen of EC in the CT scan with injection realized at day 5 of fever under antibiotics for every inclusive patient, with febrile neutropenia, and presenting digestive symptoms during the period of aplasie post-chemotherapy after exclusion from the other diagnosis (infectious colitis and other abdominal syndromes).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start14 Jan 2019
- Primary completion11 Nov 2024 (estimated)
- Study completion13 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450512
- Sponsor's protocol ID
- PI2017_843_0031
- Acronym
- DECLAM
- Status last verified
- Jul 2024
- First submitted
- 5 Feb 2018
- Last updated
- 10 Jul 2024
- 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Neutropenic Enterocolitis Study in Acute Myeloid Leukemia Patients During Intensive Therapy (DECLAM).
- ClinicalTrials.gov ID
- NCT03450512
- Acronym / sponsor ID
- DECLAM / PI2017_843_0031
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Neutropenic enterocolitis, Acute myeloid leukemia, Abdominal tomodensitometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 11 Nov 2024 (estimated)
- Study completion
- 13 Nov 2024 (estimated)
- First posted
- 1 Mar 2018 (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.
Neutropenia after induction or consolidation therapy for acute myeloid leukemia (AML) patients is associated with a high morbi-mortality rates, especially due to infectious complications. These are managed according to international recommandations (ECIL and IDSA) with antibiotherapy and antifungal strategy. Although the patients suffer of digestive symptoms, intestinale complications are really less explored. Neutropenic enterocolitis (NE), cytomegalovirus (CMV) colitis, Clostridium difficile colitis, specific lesion, ischemic colitis are not well-known. No prospective study evaluate NE and these digestive complications which have high morbi-mortality rates.
Detailed description
This is the first prospective study on digestive affections in an homogeneous cohort of hematological patients. These affections are unknown in neutropenic patients with digestive symptoms after induction or consolidation courses pour AML although causing high morbi-mortality rates (infections, denutrition, loss of autonomy…).
The aim of the study is to evaluate incidence of NE by clinical signs and with a systematic CT scan performed at day 5 of fever during aplastic period. An early diagnostic could decrease complications and evaluate gravity criteria which could imply surgery therapy.
The physician will performe a CTscan with injection during the induction and/or every consolidation, at the same time as the thoracic CTscan (to research an invasive fungal bronchopulmonary infection), in front of a febrile neutropenia with persistent fever after 5 days of antibiotics and presence of digestive signs.
The clinical, microbiological, radiological symptoms will be registered at every time of febrile neutropenia with digestive symptoms at induction and each consolidation courses. The patient will be get out of the study when the AML is refractory, hematopoietic stem cell transplantation is required or if whenever he want. The last visit will be at the end of consolidation courses.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with febrile neutropenia after induction or consolidation courses for AML( acute myeloid leukemia ).
Key inclusion criteria (5 listed)
- Age > 18 years
- Able to receive an intensive treatment for AML (induction then intensive consolidations) causing a neutropenia with high infectious risk
- In state to give its consent
- Affiliated to a social security system
Key exclusion criteria (6 listed)
- The minor patients
- The patients affected by AML not being able to receive an intensive therapy
- The patients affected by acute promyelocytic leukaemia
- The pregnant women
- The patients with HIV, hepatitis B or C
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 |
|---|---|---|
| prospective study on digestive affections in an homogeneous cohort of hematological patientsSystematic realization during the induction and/or every consolidation of a CTscan with injection, at the same time as the thoracic CTscan (to research an invasive fungal bronchopulmonary infection), in front of a febrile neutropenia with persistent fever after 5 days of antibiotics and presence of digestive signs. Statement of the information characterizing the digestive affection: clinical symptoms, microbiological, characteristic, realized additional explorations, infectious complications and specific therapeutics. The abdominal scanner will be repeated in case of suspicion of complication or clinical worsening. In case of EC, the abdominal scanner will be realized before beginning the next cycle of AML treatment to evaluate digestive remission. Finally, a CT scan, will be performed when digestive disease, digestive neoplasia or digestive symptoms are noted at AML diagnosis. | Other | – |
Primary outcome
the arisen of EC in the CT scan
Time frame: 1 day
The main assessment criteria is the arisen of EC in the CT scan with injection realized at day 5 of fever under antibiotics for every inclusive patient, with febrile neutropenia, and presenting digestive symptoms during the period of aplasie post-chemotherapy after exclusion from the other diagnosis (infectious colitis and other abdominal syndromes).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 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.
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, run by Centre Hospitalier Universitaire, Amiens 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Delphine LEBON, Doctor (0033 3 22 45 59 17, lebon.delphine@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the arisen of EC in the CT scan (time frame: 1 day). 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 Jul 2024.