NCT05133310

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

November 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

November 15, 2021

Last Update Submit

January 2, 2022

Conditions

StrainsAcute Lymphoblastic LeukemiaSepsis

Keywords

Acute lymphoblastic leukemiaSepsisFebrile NeutropeniaSimvastatin

Outcome Measures

Primary Outcomes (7)

  • Hospital Discharge

    The event in which patient is discharge from Hospital stay,

    3 months

  • Feverish Event

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

    3 months

  • Sepsis

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

    3 months

  • Neutrophils count

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

    3 months

  • Platelets count

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

    3 month

  • Blasts in marrow

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

    3 month

  • Neutrophil recovery time

    Time in days for neutrophil recovery

    1 month

Secondary Outcomes (3)

  • Bacterial isolation

    3 months

  • Procalcitonin

    3 months

  • Hospital Stay

    1 month

Study Arms (2)

Standard Care Group

NO INTERVENTION

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

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

Interventions

SimvastatinDRUG

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

Also known as: Intervention Group
Simvastatin Treatment Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General de México "Dr. Eduardo Liceaga"

Mexico City, 06720, Mexico

RECRUITING

Related Publications (3)

  • Escrihuela-Vidal F, Laporte J, Albasanz-Puig A, Gudiol C. Update on the management of febrile neutropenia in hematologic patients. Rev Esp Quimioter. 2019 Sep;32 Suppl 2(Suppl 2):55-58.

    PMID: 31475812BACKGROUND

  • Pirzad Jahromi G, P Shabanzadeh A, Mokhtari Hashtjini M, Sadr SS, Rasouli Vani J, Raouf Sarshoori J, Charish J. Bone marrow-derived mesenchymal stem cell and simvastatin treatment leads to improved functional recovery and modified c-Fos expression levels in the brain following ischemic stroke. Iran J Basic Med Sci. 2018 Oct;21(10):1004-1012. doi: 10.22038/IJBMS.2018.29382.7100.

    PMID: 30524673BACKGROUND

  • Pertzov B, Eliakim-Raz N, Atamna H, Trestioreanu AZ, Yahav D, Leibovici L. Hydroxymethylglutaryl-CoA reductase inhibitors (statins) for the treatment of sepsis in adults - A systematic review and meta-analysis. Clin Microbiol Infect. 2019 Mar;25(3):280-289. doi: 10.1016/j.cmi.2018.11.003. Epub 2018 Nov 23.

    PMID: 30472427BACKGROUND

MeSH Terms

Conditions

Sprains and StrainsPrecursor Cell Lymphoblastic Leukemia-LymphomaSepsisFebrile Neutropenia

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsNeutropeniaAgranulocytosisLeukopeniaCytopeniaLeukocyte Disorders

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Adolfo Martinez Tovar, PhD

    Hospital General de Mexico

    STUDY DIRECTOR

Central Study Contacts

Christian O Ramos Peñafiel, PhD

CONTACT

+52 55 27892000leukemiachop@hotmail.com

Adan G Gallardo Rodriguez, MSc

CONTACT

+52 55 27892000nutriologo.agallardo8@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Clinical randomized trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2021

First Posted

November 24, 2021

Study Start

November 19, 2021

Primary Completion

December 16, 2022

Study Completion

June 23, 2023

Last Updated

January 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.

Locations

ME(1)