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

Hospital General de Mexico

Status and phase: Unknown; Phase 4

Conditions: Strains; Acute Lymphoblastic Leukemia; Sepsis

Treatments: Drug: Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT05133310

HGMDI/21/204/03/63

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

108 participants in 2 patient groups

Standard Care Group

No Intervention group

Description:

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.

Simvastatin Treatment Group

Experimental group

Description:

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.

Treatment:

Drug: Simvastatin