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

Hospital General de Mexico (Other)
Overall Status
CT.gov ID

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
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:
Anticipated Enrollment :
108 participants
Intervention Model:
Parallel Assignment
Intervention Model Description:
Clinical randomized trialClinical randomized trial
None (Open Label)
Primary Purpose:
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
  • Outcome Measures

    Primary Outcome Measures

    1. Hospital Discharge [3 months]

      The event in which patient is discharge from Hospital stay,

    2. Feverish Event [3 months]

      Determination of a temperature above 38 ° persistently for more than 30 minutes

    3. Sepsis [3 months]

      Presence of hemodynamic alterations characterized by persistent hypotension, elevated heart rate, fever, and abnormal respiration

    4. Neutrophils count [3 months]

      Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle

    5. Platelets count [3 month]

      Number of platelets found in peripheral blood at the end of each chemotherapy cycle

    6. Blasts in marrow [3 month]

      Presence of more than 5% of blasts in bone marrow after each chemotherapy cycle

    7. Neutrophil recovery time [1 month]

      Time in days for neutrophil recovery

    Secondary Outcome Measures

    1. Bacterial isolation [3 months]

      Description of the germ isolated in cultures during follow-up

    2. 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

    3. Hospital Stay [1 month]

      Measurement of days of hospital stay

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    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)

    Contacts and Locations


    Site City State Country Postal Code
    1 Hospital General de México "Dr. Eduardo Liceaga" Mexico City Mexico 06720

    Sponsors and Collaborators

    • Hospital General de Mexico


    • Study Director: Adolfo Martinez Tovar, PhD, Hospital General de Mexico

    Study Documents (Full-Text)

    None provided.

    More Information


    Responsible Party:
    Christian Omar Ramos-Peñafiel, MD, PhD, Principal Investigator, Hospital General de Mexico
    ClinicalTrials.gov Identifier:
    Other Study ID Numbers:
    • HGMDI/21/204/03/63
    First Posted:
    Nov 24, 2021
    Last Update Posted:
    Jan 4, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Product Manufactured in and Exported from the U.S.:
    Keywords provided by Christian Omar Ramos-Peñafiel, MD, PhD, Principal Investigator, Hospital General de Mexico
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 4, 2022