D-index as a Predictor of Complication of Treatment of Patients With Acute Myeloid Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2026-06-30

Brief Summary

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1. The effect of D-index on the onset and severity of FN in AML patients.
2. Relationship between the c-D-index and duration of FN in AML patients.
3. Correlation between D-index and MDR.
4. Correlation between D-index and invasive fungal infection.
5. Comparison of FN in different treatment protocols for AML using D-index.
6. Prediction of pulmonary, fungal or blood stream infection.

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Detailed Description

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Acute myeloid leukemia (AML) is highly malignant neoplasm responsible for a large number of cancer-related deaths. It continuously shows 2 peaks in occurrence in early childhood and later adulthood. With an incidence of 3.7 per 100,000 persons per year.

Neutropenia, defined as the absolute neutrophil count (ANC) below 500 cells/ μL or ANC expected to drop below 500 cells/ μL in the next 48 h, represents a potentially fatal complication and is associated with a high risk of developing bacterial infections. Fever is defined as having a bodily temperature above 38.3 ˚C, measured orally, or two measurements above 38 ˚C that are taken at different time points, at least an hour apart.

Concomitance of severe neutropenia (≤ 500 cells/ μL) with high fever (≥ 38.3˚C) is called febrile neutropenia (FN) by the definition of the Infectious Diseases Society of America (IDSA).

Invasive fungal infection (IFI) and bacterial blood stream infection (BSI) consideded a major complications during AML treatment and associated with high morbidity and mortality. Immunosuppression caused by chemotherapy and prolonged hospitalizations expose AML patients to life threatening infections, which can be sustained by multi-drug resistant organisms (MDROs), accounting for one of the major causes of mortality.

A clinical parameter that evaluates the dynamics of neutropenia, combining intensity and duration, could be a good tool to identify patients at high risk for infection. This tool could be used to stratify patients, helping clinicians to select appropriate antibiotics and antifungal therapy in persistently febrile neutropenic patients. An index (called the D-index) that uses data from WBC counts and combines intensity and duration of neutropenia.

The D-index was developed by the calculated area over the neutrophil curve from the plot of ANC\<500 /μl and duration of grade 4 neutropenia. Cumulative D-index (c-D-index) was also defined from the grade 4 neutropenia to the onset of febrile neutropenia, it reflects an accumulation of neutropenia until FN. Therefore, this study aim to describe and investigate the impacts of D-index performance on infectious complications in adult AML patients who developed the first episode of FN after receiving high-intensity chemotherapy.

Conditions

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AML, Adult

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Adult Patients (≥18 years) newly diagnosed as acute myeloid leukemia according to WHO 2016 diagnostic criteria.
2. Hematologic diagnosis of de novo AML.
3. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
4. Standard induction chemotherapy (7+3 regimen) or consolidation regimens (HiDAC).

Exclusion Criteria

1\) AML on top of other hematological disorders. 2) Acute promyelocytic leukemia. 3) Patients who received palliative care or low-intensity treatment. 4) Poor PS (≥3) at the time of diagnosis.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No