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

Sponsor

Hospital General de Mexico (Other)

Overall Status

Recruiting

CT.gov ID

NCT05133310

Collaborator

(none)

108

Enrollment

Location

Arms

19.1

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Strains Acute Lymphoblastic Leukemia Sepsis	Drug: Simvastatin	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Clinical randomized trialClinical randomized trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 19, 2021

Anticipated Primary Completion Date :

Dec 16, 2022

Anticipated Study Completion Date :

Jun 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 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.
Experimental: 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.	Drug: Simvastatin Combination of Simvastatin with Standard Chemotherapy scheme for acute lymphoblastic patients. Other Names: Intervention Group

Arm

Intervention/Treatment

No Intervention: 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.

Experimental: 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.

Drug: Simvastatin

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

Other Names:

Intervention Group

Outcome Measures

Primary Outcome Measures

Hospital Discharge [3 months]
The event in which patient is discharge from Hospital stay,
Feverish Event [3 months]
Determination of a temperature above 38 ° persistently for more than 30 minutes
Sepsis [3 months]
Presence of hemodynamic alterations characterized by persistent hypotension, elevated heart rate, fever, and abnormal respiration
Neutrophils count [3 months]
Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle
Platelets count [3 month]
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Blasts in marrow [3 month]
Presence of more than 5% of blasts in bone marrow after each chemotherapy cycle
Neutrophil recovery time [1 month]
Time in days for neutrophil recovery

Secondary Outcome Measures

Bacterial isolation [3 months]
Description of the germ isolated in cultures during follow-up
Procalcitonin [3 months]
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
Hospital Stay [1 month]
Measurement of days of hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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)