Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia

Sepsis Clinical Trial

Official title:

Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05133310
• Other study ID #: HGMDI/21/204/03/63
• Status: Recruiting
• Phase: Phase 4
• Start date: November 19, 2021
• Est. completion date: June 23, 2023

Study information

• Verified date: January 2022
• Source: Hospital General de Mexico
• Contact: Christian O Ramos Peñafiel, PhD
• Phone: +52 55 27892000
• Email: leukemiachop[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In general, the percentage of complete remissions is 85 - 90 % for acute lymphoid leukemia (ALL). In developing countries, percentages are lower secondary to higher sepsis-related mortality. Although the effect of statins on inflammatory response associated with sepsis has been demonstrated, including an effect on bacterial proliferation in patients with a state of immunosuppression, their effect has not been demonstrated so far in patients with hemato-oncological cancer.

Description:

Death associated with sepsis is one of the principal complications related to chemotherapy treatment; there are currently no strategies to prevent its development besides the use of prophylactic antibiotics or granulocyte colony stimulants to reduce the period of febrile neutropenia. Most of the trials on the use of statins are retrospective with controversial results and include patients with different clinical situations that conditioned the septic study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: June 23, 2023
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Patients diagnosed with acute leukemia under treatment of a chemotherapy regimen

• 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:

• Patients with acute leukemias over 55 years of age and with impaired functional status at the time of diagnosis

• 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)

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Febrile Neutropenia
• Leukemia
• Leukemia, Lymphoid
• Neutropenia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Sepsis
• Strains
• Toxemia

Intervention

Drug:
• Simvastatin
Combination of Simvastatin with Standard Chemotherapy scheme for acute lymphoblastic patients.

Locations

Country	Name	City	State
Mexico	Hospital General de México "Dr. Eduardo Liceaga"	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital General de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

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 2:55-58. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Discharge	The event in which patient is discharge from Hospital stay,	3 months
Primary	Feverish Event	Determination of a temperature above 38 ° persistently for more than 30 minutes	3 months
Primary	Sepsis	Presence of hemodynamic alterations characterized by persistent hypotension, elevated heart rate, fever, and abnormal respiration	3 months
Primary	Neutrophils count	Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle	3 months
Primary	Platelets count	Number of platelets found in peripheral blood at the end of each chemotherapy cycle	3 month
Primary	Blasts in marrow	Presence of more than 5% of blasts in bone marrow after each chemotherapy cycle	3 month
Primary	Neutrophil recovery time	Time in days for neutrophil recovery	1 month
Secondary	Bacterial isolation	Description of the germ isolated in cultures during follow-up	3 months
Secondary	Procalcitonin	Biomarker used in infectious and inflammatory processes associated mainly with gram-negative germs, this measurement is routine in the follow-up of individuals with febrile neutropenia	3 months
Secondary	Hospital Stay	Measurement of days of hospital stay	1 month