Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia
NCT ID: NCT05133310
Last Updated: 2022-01-04
Study Results
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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UNKNOWN
PHASE4
108 participants
INTERVENTIONAL
2021-11-19
2023-06-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Care Group
Patients will receive the standard chemotherapy regimen assigned for their treatment and, they will be followed and monitored until the end of treatment and hospitalization.
No interventions assigned to this group
Simvastatin Treatment Group
Patients will combine the standard CALGB treatment scheme plus Simvastatin 10mg orally every 24 hours during the first 7 days of treatment and then continue with 20mg every 24 hours until the end of treatment and hospitalization.
Simvastatin
Combination of Simvastatin with Standard Chemotherapy scheme for acute lymphoblastic patients.
Interventions
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Simvastatin
Combination of Simvastatin with Standard Chemotherapy scheme for acute lymphoblastic patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Stable performance status (ECOG: 0 or Karnofsky scale greater than 80%) at time of analysis and under chemotherapy regimen
* Life expectancy greater than 48 hours after diagnosis
* Oral route available
* Have signed informed consent at the time of the study
* Patients whose chemotherapy regimen is administered in a hospital rather than an outpatient manner
Exclusion Criteria
* Elevation of liver enzymes 3 times higher than the range established by the central laboratory
* Persistent kidney involvement despite having adequate hydration
* Pregnant patients
* Patients with peripheral neuropathy considered severe or disabling grade
* Patients with a history of psychiatric disorders or psychotic attacks
* Individuals who do not have the oral route available, who are maintained with a nasogastric tube, or who require support for the diagnosis through parenteral nutrition
* Patients undergoing peritoneal dialysis or hemodialysis treatment
* Patients with leukemia associated with Down syndrome
* Patients under low-intensity chemotherapy regimen or palliative regimen
* Previous allergy to any statin component
* Patients with a history of liver failure (Child-Pugh Stage B or C)
18 Years
55 Years
ALL
No
Sponsors
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Hospital General de Mexico
OTHER_GOV
Responsible Party
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Christian Omar Ramos-Peñafiel, MD, PhD
Principal Investigator
Principal Investigators
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Adolfo Martinez Tovar, PhD
Role: STUDY_DIRECTOR
Hospital General de Mexico
Locations
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Hospital General de México "Dr. Eduardo Liceaga"
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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Escrihuela-Vidal F, Laporte J, Albasanz-Puig A, Gudiol C. Update on the management of febrile neutropenia in hematologic patients. Rev Esp Quimioter. 2019 Sep;32 Suppl 2(Suppl 2):55-58.
Pirzad Jahromi G, P Shabanzadeh A, Mokhtari Hashtjini M, Sadr SS, Rasouli Vani J, Raouf Sarshoori J, Charish J. Bone marrow-derived mesenchymal stem cell and simvastatin treatment leads to improved functional recovery and modified c-Fos expression levels in the brain following ischemic stroke. Iran J Basic Med Sci. 2018 Oct;21(10):1004-1012. doi: 10.22038/IJBMS.2018.29382.7100.
Pertzov B, Eliakim-Raz N, Atamna H, Trestioreanu AZ, Yahav D, Leibovici L. Hydroxymethylglutaryl-CoA reductase inhibitors (statins) for the treatment of sepsis in adults - A systematic review and meta-analysis. Clin Microbiol Infect. 2019 Mar;25(3):280-289. doi: 10.1016/j.cmi.2018.11.003. Epub 2018 Nov 23.
Other Identifiers
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HGMDI/21/204/03/63
Identifier Type: -
Identifier Source: org_study_id
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