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

• Status: Not yet recruiting
• Trial end date: 2023-06-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital General de Mexico
• Treatments: Simvastatin

Criteria

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)