Using a NEWS early warning score to prompt ICU admission for adults receiving intensive chemotherapy or stem cell transplant
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
Run by University Hospital, Angers · NCT06409767 · Data updated 2026-11-12
This trial tests whether real-time monitoring with the NEWS early warning score and prompt ICU admission (NEWS ≥ 7) helps adults with leukemia, lymphoma, or multiple myeloma who are receiving intensive chemotherapy or a hematopoietic cell transplant.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2224 (estimated) |
| Sponsor | University Hospital, Angers Government |
| Drugs / interventions | chemotherapy |
| Locations | 10 sites (Amiens and 9 other locations) |
| Status | Recruiting |
| Started | April 10, 2025 |
| Main results expected | April 11, 2028 |
| Study ends | July 11, 2028 |
| Registry record updated | September 24, 2025 |
| Trial ID | NCT06409767 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults hospitalized in a protected hematology unit for induction therapy for acute myeloid or lymphoblastic leukemia, or for intensive chemotherapy with autologous or allogeneic hematopoietic cell transplantation, with an expected stay of at least seven days and able to provide informed consent.
✕Probably not a fit
Patients with a prior decision limiting ICU transfer or organ support, those admitted for CAR T‑cell therapy, pregnant or breastfeeding women, and people unable to give consent are not expected to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this interventional study, clinical teams calculate the National Early Warning Score (NEWS) in real time for adults hospitalized in protected hematology units for induction therapy of acute leukemias or for intensive chemotherapy with autologous or allogeneic hematopoietic cell transplantation. The protocol calls for prompt ICU admission when a patient’s NEWS reaches or exceeds 7 to allow earlier organ-specific interventions and closer monitoring. Outcomes such as survival, timing of organ support, ICU use, and patient-centered effects will be compared between the NEWS-driven pathway and usual monitoring. The study also monitors for potential downsides, including increased ICU resource use and patient anxiety resulting from earlier transfers.
Why it matters
Potential benefit: If successful, this approach could increase survival by enabling earlier detection of organ failure and faster initiation of life‑support measures.
How similar studies have gone: Early warning systems using vital signs have been studied by multiple teams and can detect deterioration earlier, but their effect on survival specifically in hematologic cancer patients is still unclear.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
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Centre Hospitalier Amiens-Picardie
Amiens, France Recruiting -
Centre Hospitalier Universitaire d'Angers
Angers, France Recruiting -
Centre Hospitalier Universitaire Besancon
Besançon, France Recruiting -
Centre Hospitalier Universitaire Brest
Brest, France Recruiting -
Centre Hospitalier universitaire Nancy
Nancy, France Recruiting -
Centre Hospitalier Universitaire Nantes
Nantes, France Recruiting
Show 4 more locations
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Centre Hospitalier Universitaire poitiers
Poitiers, France Recruiting -
centre Hospitalier Universitaire Saint etienne
Saint-Etienne, France Recruiting -
centre Hospitalier Universitaire Tours
Tours, France Recruiting -
centre Hospitalier Universitaire Strasbourg
Strasbourg, France Not yet recruiting
Study contacts
- Study coordinator: Corentin Orvain, MD PhD
- Email: Corentin.Orvain@chu-angers.fr
- Phone: 02 41 35 36 37
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.