LeukemiaALHERTNCT06409767
Impact of an Early Warning System on the Prognosis of Patients With Hematological Malignancies Receiving Intensive Chemotherapy With or Without Hematopoietic Cell Transplantation.
A study testing Real-time calculation of the NEWS with ICU admission if NEWS ≥ 7. in people with Leukemia and Lymphoma, run by University Hospital, Angers at 10 sites in France.
Trial summary
Patients with hematologic malignancies requiring intensive chemotherapy are at risk for life-threatening complications. Organ failure may appear rapidly and delay in initiating life-sustaining interventions may result in increased mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia, Lymphoma, Multiple Myeloma
- What is being tested?
- Real-time calculation of the NEWS with ICU admission if NEWS ≥ 7.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,224 participants
- Where
- 10 sitesFrance
- Study dates
- 10 Apr 2025to 11 Jul 2028
- 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
- Hospitalization in a protected unit of a hematology department for induction therapy of acute myeloid leukemia or acute lymphoblastic leukemia induction, intensive chemotherapy with autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation
- Expected length of stay in the hematology department of at least 7 days
- Patient with social security
- Signed informed consent form
Who cannot join
- Decision of care limitation with decision not to transfer to ICU or not initiate organ support
- Pregnant, parturient or breastfeeding woman
- Person deprived of liberty by judicial or administrative decision
- Person under forced psychiatric care
- Person under legal protection
- Person unable to express consent
- Hospitalization for Chimeric Antigenic Receptor (CAR) T-cell therapy
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
Centre Hospitalier Amiens-Picardie
Amiens, 80054
Delphine LEBON, PhD, 03 22 45 59 14 ext. +33, lebon.delphine@chu-amiens.fr
- Recruiting
Centre Hospitalier Universitaire d'Angers
Angers, 49933
Corentin Orvain, PhD, 02 41 35 44 75 ext. +33, corentin.orvain@chu-angers.fr
- Recruiting
Centre Hospitalier Universitaire Besancon
Besançon, 25030
Yohan Desbrosses, PhD, 03 81 66 82 32 ext. +33, ydesbrosses@chu-besancon.fr
- Recruiting
Centre Hospitalier Universitaire Brest
Brest, 29609
Marie-Anne Couturier, PhD, 02 98 22 30 37, marie-anne.couturier@chu-brest.fr
- Recruiting
Centre Hospitalier universitaire Nancy
Nancy, 45011
Caroline Bonmati, PhD, 03 83 15 32 82 ext. +33, c.bonmati@chru-nancy.fr
- Recruiting
Centre Hospitalier Universitaire Nantes
Nantes, 44093
Pierre Peterlin, PhD, 02 40 08 32 71, pierre.peterlin@chu-nantes.fr
- Recruiting
Centre Hospitalier Universitaire poitiers
Poitiers, 86021
Maria-Pilar Gallego-Hernanz, PhD, 05 49 44 43 07 ext. +33, maria-pilar@gallego-hernanz@chupoitiers.fr
- Recruiting
centre Hospitalier Universitaire Saint etienne
Saint-Etienne, 42270
Emmanuelle Tavernier, PhD, 04 77 91 70 60, Emmanuelle.Tavernier@chu-stetienne.fr
- Not yet recruiting
centre Hospitalier Universitaire Strasbourg
Strasbourg, 67098
Célestine Simand, PhD, 03 68 76 74 07 ext. +33, c.simand@icans.eu
- Recruiting
centre Hospitalier Universitaire Tours
Tours, 37044
Alban Villate, PhD, 02 47 47 37 12 ext. +33, a.villate@chu-tours.fr
About this study
Official title: Impact of an Early Warning System on the Prognosis of Patients With Hematological Malignancies Receiving Intensive Chemotherapy With or Without Hematopoietic Cell Transplantation, a Multicenter Cluster Randomized Study
Patients with hematologic malignancies requiring intensive chemotherapy are at risk for life-threatening complications. Organ failure may appear rapidly and delay in initiating life-sustaining interventions may result in increased mortality. This encourages great alertness although not all patients require close monitoring. It is therefore critical to identify which patients are the most at risk for clinical deterioration to consider increased surveillance in these patients. The benefit of early intensive care unit (ICU) admission, as soon as the first signs of organ dysfunction appear, must also be clarified. Such an intervention could increase survival of patients by close monitoring and early initiation of organ-specific interventions but could also be responsible for anxiety and increased use of ICU resources.
Many teams have analyzed the impact of early warning systems (EWS) including vital signs to detect organ dysfunction early on. It has been shown that these EWS could positively impact survival in many medical fields (pre-hospital, medicine or surgery departments). A few retrospective studies have explored the impact of EWS in hematology, with overall good prediction for ICU admission and mortality. Until now, it has however not been formally demonstrated that early ICU admission, as soon as the first signs of organ dysfunction appear, could benefit patients with hematologic malignancies. A randomized controlled trial studying the impact of early intervention would clarify the role of such a strategy.
In this study, the investigators will prospectively evaluate the implementation of the National Early Warning Score (NEWS), with systematic referral to the ICU in high-score patients, to improve the survival of patients receiving intensive chemotherapy in ten academic centers. This score is one of the most performant and most frequently used to predict organ failure. Its calculation only requires vital signs such as respiratory rate, peripheral oxygen saturation, need for oxygen therapy, body temperature, arterial pressure, heart rate, and level of consciousness. The investigators will therefore study the impact of ICU admission in patients with high NEWS in a randomized, controlled trial. A cluster randomization is planned in which the centers will be randomized between usual care (control group) and interventional care with transfer to the ICU in the event of a NEWS score ≥7 (interventional group). Each parameter used to calculate the NEWS will be collected at least three times a day by the attending nurse.
- Conditions
- Leukemia, Lymphoma, Multiple Myeloma
- Being tested
- Real-time calculation of the NEWS with ICU admission if NEWS ≥ 7.
- Keywords
- Intensive chemotherapy, hematopoietic cell transplantation, early ICU admission
- Medical subject headings
- Leukemia, Lymphoma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time calculation of the NEWS with ICU admission if NEWS ≥ 7.Other
The calculation of NEWS requires vital signs such as respiratory rate, peripheral oxygen saturation, need for oxygen therapy, body temperature, arterial pressure, heart rate, and level of consciousness. Each parameter used to calculate the NEWS will be collected least three times a day by the attending nurse.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Not described Receives: Other: Real-time calculation of the NEWS with ICU admission if NEWS ≥ 7. |
| Control arm | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospitality mortality and/or inition of organ support
In-hospital mortality and/or initiation of organ support (invasive mechanical ventilation, vasopressors [Epinephrin, Dobutamine or Adrenaline], renal replacement therapy, extracorporeal circulation [ECMO]).
Measured: 3 months
Secondary outcomes (4)
Relative weight of each parameter used to calculate the NEWS for predicting the risk of organ failure requiring life-sustaining organ support
Cox proportional hazards model with shared fragility to explain the occurrence over time of one or more organ support. The model's explanatory variables will be the different parameters used to calculate the NEWS.
Measured: 3 months
Feasibility of implementing early warning scores in routine practice
Proportion of patients with NEWS ≥7 effectively admitted to the ICU in the investigational arm.
Measured: 3 months
To assess quality of life of patients according to treatment arm.
Quality of life scores measured by the EQ-5D-5L questionnaire at days 0, 30, and 90 will be analyzed using linear mixed models (LMM) to account for repeated measures, for both the overall score and each dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression).
Measured: 3 months
economic evaluation
Cost-utility analysis will estimate the incremental cost utility ratio (ICUR) in cost per quality-adjusted life year (QALY) gained and cost-effectiveness analysis will estimate the incremental cost effectiveness ratio (ICER) in cost per life year gained.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start10 Apr 2025
- Primary completion11 Apr 2028 (estimated)
- Study completion11 Jul 2028 (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 LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized trial
- Masking
- None (open label)
- Enrolment
- 2,224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409767
- Sponsor's protocol ID
- 49RC23_0425
- Other IDs
- ID-RCB
- Acronym
- ALHERT
- Status last verified
- Sep 2025
- First submitted
- 7 May 2024
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Taillantou-Candau M, Kouatchet A, Darsonval A, Monmousseau F, Darras E, Schmidt A, Riou J, Orvain C. Impact of an early warning system on the outcome of patients with haematological malignancies receiving high-dose chemotherapy with or without haematopoietic cell transplantation: a protocol of the ALHERT cluster randomised trial. BMJ Open. 2026 Mar 19;16(3):e113466. doi: 10.1136/bmjopen-2025-113466.
PubMed 41856593
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Early Warning System on the Prognosis of Patients With Hematological Malignancies Receiving Intensive Chemotherapy With or Without Hematopoietic Cell Transplantation, a Multicenter Cluster Randomized Study
- ClinicalTrials.gov ID
- NCT06409767
- Acronym / sponsor ID
- ALHERT / 49RC23_0425
- Conditions
- Leukemia, Lymphoma, Multiple Myeloma
- Keywords
- Intensive chemotherapy, hematopoietic cell transplantation, early ICU admission
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,224 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 11 Apr 2028 (estimated)
- Study completion
- 11 Jul 2028 (estimated)
- First posted
- 10 May 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.
Patients with hematologic malignancies requiring intensive chemotherapy are at risk for life-threatening complications. Organ failure may appear rapidly and delay in initiating life-sustaining interventions may result in increased mortality. This encourages great alertness although not all patients require close monitoring. It is therefore critical to identify which patients are the most at risk for clinical deterioration to consider increased surveillance in these patients. The benefit of early intensive care unit (ICU) admission, as soon as the first signs of organ dysfunction appear, must also be clarified. Such an intervention could increase survival of patients by close monitoring and early initiation of organ-specific interventions but could also be responsible for anxiety and increased use of ICU resources.
Many teams have analyzed the impact of early warning systems (EWS) including vital signs to detect organ dysfunction early on. It has been shown that these EWS could positively impact survival in many medical fields (pre-hospital, medicine or surgery departments). A few retrospective studies have explored the impact of EWS in hematology, with overall good prediction for ICU admission and mortality. Until now, it has however not been formally demonstrated that early ICU admission, as soon as the first signs of organ dysfunction appear, could benefit patients with hematologic malignancies. A randomized controlled trial studying the impact of early intervention would clarify the role of such a strategy.
In this study, the investigators will prospectively evaluate the implementation of the National Early Warning Score (NEWS), with systematic referral to the ICU in high-score patients, to improve the survival of patients receiving intensive chemotherapy in ten academic centers. This score is one of the most performant and most frequently used to predict organ failure. Its calculation only requires vital signs such as respiratory rate, peripheral oxygen saturation, need for oxygen therapy, body temperature, arterial pressure, heart rate, and level of consciousness. The investigators will therefore study the impact of ICU admission in patients with high NEWS in a randomized, controlled trial. A cluster randomization is planned in which the centers will be randomized between usual care (control group) and interventional care with transfer to the ICU in the event of a NEWS score ≥7 (interventional group). Each parameter used to calculate the NEWS will be collected at least three times a day by the attending nurse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Other: Real-time calculation of the NEWS with ICU admission if NEWS ≥ 7. |
| Control arm | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient
- Hospitalization in a protected unit of a hematology department for induction therapy of acute myeloid leukemia or acute lymphoblastic leukemia induction, intensive chemotherapy with autologous hematopoietic cell transplantation, allogeneic hematopoietic cell transplantation
- Expected length of stay in the hematology department of at least 7 days
- Patient with social security
- Signed informed consent form
Key exclusion criteria (7 listed)
- Decision of care limitation with decision not to transfer to ICU or not initiate organ support
- Pregnant, parturient or breastfeeding woman
- Person deprived of liberty by judicial or administrative decision
- Person under forced psychiatric care
- Person under legal protection
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 |
|---|---|---|
| Real-time calculation of the NEWS with ICU admission if NEWS ≥ 7.The calculation of NEWS requires vital signs such as respiratory rate, peripheral oxygen saturation, need for oxygen therapy, body temperature, arterial pressure, heart rate, and level of consciousness. Each parameter used to calculate the NEWS will be collected least three times a day by the attending nurse. | Other | Interventional arm |
Primary outcome
In-hospitality mortality and/or inition of organ support
Time frame: 3 months
In-hospital mortality and/or initiation of organ support (invasive mechanical ventilation, vasopressors [Epinephrin, Dobutamine or Adrenaline], renal replacement therapy, extracorporeal circulation [ECMO]).
4 secondary outcomes
Relative weight of each parameter used to calculate the NEWS for predicting the risk of organ failure requiring life-sustaining organ support
Time frame: 3 months
Feasibility of implementing early warning scores in routine practice
Time frame: 3 months
To assess quality of life of patients according to treatment arm.
Time frame: 3 months
economic evaluation
Time frame: 3 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 24 Sep 2025.
- Derived from this study: PubMed 41856593Taillantou-Candau M, Kouatchet A, Darsonval A, Monmousseau F, Darras E, Schmidt A, Riou J, Orvain C. Impact of an early warning system on the outcome of patients with haematological malignancies receiving high-dose chemotherapy with or without haematopoietic cell transplantation: a protocol of the ALHERT cluster randomised trial. BMJ Open. 2026 Mar 19;16(3):e113466. doi: 10.1136/bmjopen-2025-113466.
- Individual participant dataSharing planned: No
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time calculation of the NEWS with ICU admission if NEWS ≥ 7. in people with Leukemia and Lymphoma, run by University Hospital, Angers at 10 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 7 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 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 Corentin Orvain, MD PhD (02 41 35 36 37 ext. +33, Corentin.Orvain@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospitality mortality and/or inition of organ support (time frame: 3 months). 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 NCT06409767, 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 24 Sep 2025.