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Completed

NCT Number: NCT06709235

Assessing Refractoriness and Infectious Survival Events in AML

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Lyon Sud

Pierre-Bénite, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Characterization of Infectious Events and Their Impact on Survival in Patients with Acute Myeloid Leukemia Treated with Intensive Chemotherapy

Acronym: ARISE-AML

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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