Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06188182
Other study ID # neutropnic fever in AML
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2024
Est. completion date June 2026

Study information

Verified date January 2024
Source Assiut University
Contact Esraa Nageh
Phone 01012386384
Email esraanageh24434@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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. -

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (7)

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

Outcome

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04623944 - NKX101, Intravenous Allogeneic CAR NK Cells, in Adults With AML or MDS Phase 1
Not yet recruiting NCT06313437 - Revumenib in Combination With 7+3 + Midostaurin in AML Phase 1
Terminated NCT04079738 - Study Augmenting TAK-659 Action in Relapsed/Refractory AML by Addition Ofthe Proteasome Inhibitor Ixazomib Phase 1/Phase 2
Recruiting NCT06052813 - A Study of BN104 in the Treatment of Acute Leukemia Phase 1/Phase 2
Recruiting NCT06027853 - Natural Killer(NK) Cell Therapy Targeting CLL1 in Acute Myeloid Leukemia Phase 1
Completed NCT02986620 - Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia
Recruiting NCT05601466 - Natural Killer(NK) Cell Therapy for Acute Myeloid Leukemia Phase 1
Recruiting NCT06066905 - A Study of Chidamide With AZA in MRD Positive AML After Transplant N/A
Recruiting NCT05909501 - Assessment of Geriatric Evaluations Impact on New AML Guidance
Terminated NCT04614636 - FT538 in Subjects With Advanced Hematologic Malignancies Phase 1
Not yet recruiting NCT06420063 - Sequential CAR-T Cells Targeting CD33/CD123 in Patients With Acute Myelocytic Leukemia AML Phase 1/Phase 2
Withdrawn NCT04128020 - Azacitidine Plus Nivolumab Following Reduced-intensity Allogeneic PBSC Transplantation for Patients With AML and High-risk Myelodysplasia Phase 1
Active, not recruiting NCT04749355 - Phase 2, Open-Label, Single Arm Study, With BST-236 in Adults With R/R AML or Higher-Risk MDS Phase 2
Active, not recruiting NCT04755244 - A Study of Evorpacept (ALX148) With Venetoclax and Azacitidine for Acute Myeloid Leukemia (ASPEN-05) Phase 1/Phase 2
Completed NCT03194685 - Study of FF-10101-01 in Patients With Relapsed or Refractory Acute Myeloid Leukemia Phase 1/Phase 2
Recruiting NCT03884829 - A Phase I Study of CYC140, a PLK-1 Inhibitor, in Advanced Leukemias or MDS Phase 1
Active, not recruiting NCT05177731 - Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML Phase 3
Not yet recruiting NCT06377579 - OBServatory of Compassionate Use of IVOsidenib in France for Patients With Acute Myeloid Leukemia
Recruiting NCT05025098 - Precision Therapy Versus Standard Therapy in AML and MDS in Elderly Phase 2
Not yet recruiting NCT06263387 - Results From a French Temporary Utilization Authorization of First-line Acute Myeloid Leukemia (AML) Patients Ineligible for Intensive Chemotherapy (IC), Treated With Venetoclax Azacitidine