AML, Adult Clinical Trial
Official title:
D-index as a Predictor of Complications of Febrile Neutropenia in Patients With Acute Myeloid Leukemia
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | June 2026 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. - |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Assiut University |
Amanati A, Sajedianfard S, Khajeh S, Ghasempour S, Mehrangiz S, Nematolahi S, Shahhosein Z. Bloodstream infections in adult patients with malignancy, epidemiology, microbiology, and risk factors associated with mortality and multi-drug resistance. BMC Inf — View Citation
Boeriu E, Borda A, Vulcanescu DD, Sarbu V, Arghirescu ST, Ciorica O, Bratosin F, Marincu I, Horhat FG. Diagnosis and Management of Febrile Neutropenia in Pediatric Oncology Patients-A Systematic Review. Diagnostics (Basel). 2022 Jul 25;12(8):1800. doi: 10 — View Citation
Deschler B, Lubbert M. Acute myeloid leukemia: epidemiology and etiology. Cancer. 2006 Nov 1;107(9):2099-107. doi: 10.1002/cncr.22233. — View Citation
Freifeld AG, Bow EJ, Sepkowitz KA, Boeckh MJ, Ito JI, Mullen CA, et al. Clinical practice guideline for the use of antimicrobial agents in neutropenic patients with cancer: 2010 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2011;5
Guarnera L, Trotta GE, Boldrini V, Cardillo L, Cerroni I, Mezzanotte V, et al. Fever of Unknown Origin and Multidrug Resistant Organism Colonization in AML Patients. Mediterr J Hematol Infect Dis. 2023;15(1).
Portugal RD, Garnica M, Nucci M. Index to predict invasive mold infection in high-risk neutropenic patients based on the area over the neutrophil curve. J Clin Oncol. 2009 Aug 10;27(23):3849-54. doi: 10.1200/JCO.2008.21.0856. Epub 2009 Jul 13. — View Citation
Rattanathammethee T, Munsamai K, Punnachet T, Hantrakun N, Piriyakhuntorn P, Hantrakool S, Chai-Adisaksopha C, Rattarittamrong E, Tantiworawit A, Norasetthada L. D-index and invasive fungal infections (IFIs) in adult acute myeloid leukemia (AML) patients — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The effect of D-index on the onset and severity of FN in AML patients. | Determine if the D-index can predict the onset, severity, duration and complications of febrile neutropenia | during the period of chemotherapy completion, an average of 1 year |
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