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NCT06709235Completed

Assessing Refractoriness and Infectious Survival Events in AML

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

Source: ClinicalTrials.gov · Last updated 29 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
280 (actual)
First submitted
21 Nov 2024
Start date
1 May 2024
Primary completion date
1 May 2024
Lead sponsor
Hospices Civils de Lyon
NCT number
NCT06709235

What you commit to

  • Study type: Observational
  • Participants enrolled: 280
  • From 1 May 2024 to the primary completion date, 1 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Treatment with "non-intensive" chemotherapy (i.e. azacytidine)
  • Death before first post-chemotherapy bone marrow assessment

Other

  • Patients with acute promyelocytic leukemia (AML 3)
  • No computerized data available
  • Follow-up at a center other than HCL

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hopital Lyon Sud
Coordinator of this site? Confirm its status
Pierre-BéniteFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.