NCT05133310

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Hospital General de Mexico · Other Government
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Strains
• Acute Lymphoblastic Leukemia
• Sepsis

Interventions

Type	Name	Description
DRUG	Simvastatin	Combination of Simvastatin with Standard Chemotherapy scheme for acute lymphoblastic patients.

Timeline

• Start date: 2021-11-19
• Primary completion: 2022-12-16
• Completion: 2023-06-23
• First posted: 2021-11-24
• Last updated: 2022-01-04

Locations

1 site across 1 country: Mexico