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

Primary Purpose

Strains, Acute Lymphoblastic Leukemia, Sepsis

Status

Recruiting

Phase

Phase 4

Locations

Mexico

Study Type

Interventional

Intervention

Simvastatin

About this trial

This is an interventional treatment trial for Strains focused on measuring Acute lymphoblastic leukemia, Sepsis, Febrile Neutropenia, Simvastatin

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

Hospital General de México "Dr. Eduardo Liceaga"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care Group

Simvastatin Treatment Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Hospital Discharge

The event in which patient is discharge from Hospital stay,

Feverish Event

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

Sepsis

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

Neutrophils count

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

Platelets count

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

Blasts in marrow

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

Neutrophil recovery time

Time in days for neutrophil recovery

Secondary Outcome Measures

Bacterial isolation

Description of the germ isolated in cultures during follow-up

Procalcitonin

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

Measurement of days of hospital stay

Full Information

NCT ID

NCT05133310

First Posted

November 15, 2021

Last Updated

January 2, 2022

Sponsor

Hospital General de Mexico

1. Study Identification

Unique Protocol Identification Number

NCT05133310

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 19, 2021 (Actual)

Primary Completion Date

December 16, 2022 (Anticipated)

Study Completion Date

June 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital General de Mexico

4. Oversight

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.

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Strains, Acute Lymphoblastic Leukemia, Sepsis

Keywords

Acute lymphoblastic leukemia, Sepsis, Febrile Neutropenia, Simvastatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Clinical randomized trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

108 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Care Group

Arm Type

No Intervention

Arm 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.

Arm Title

Simvastatin Treatment Group

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Other Intervention Name(s)

Intervention Group

Intervention Description

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

Primary Outcome Measure Information:

Title

Hospital Discharge

Description

The event in which patient is discharge from Hospital stay,

Time Frame

3 months

Title

Feverish Event

Description

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

Time Frame

3 months

Title

Sepsis

Description

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

Time Frame

3 months

Title

Neutrophils count

Description

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

Time Frame

3 months

Title

Platelets count

Description

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

Time Frame

3 month

Title

Blasts in marrow

Description

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

Time Frame

3 month

Title

Neutrophil recovery time

Description

Time in days for neutrophil recovery

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Bacterial isolation

Description

Description of the germ isolated in cultures during follow-up

Time Frame

3 months

Title

Procalcitonin

Description

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

Time Frame

3 months

Title

Hospital Stay

Description

Measurement of days of hospital stay

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian O Ramos Peñafiel, PhD

Phone

+52 55 27892000

Ext

2020

leukemiachop@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Adan G Gallardo Rodriguez, MSc

Phone

+52 55 27892000

Ext

2020

nutriologo.agallardo8@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Adolfo Martinez Tovar, PhD

Organizational Affiliation

Hospital General de Mexico

Official's Role

Study Director

Facility Information:

Facility Name

Hospital General de México "Dr. Eduardo Liceaga"

City

Mexico City

ZIP/Postal Code

06720

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian O Ramos Peñafiel, PhD

Phone

+52 55 2789 2000

Ext

2020

leukemiachop@hotmail.com

First Name & Middle Initial & Last Name & Degree

Adan G Gallardo-Rodriguez, MSc

Phone

+52 55 2789 2000

Ext

2020

nutriologo.agallardo8@gmail.com

First Name & Middle Initial & Last Name & Degree

Carlos Martínez Murillo, PhD

First Name & Middle Initial & Last Name & Degree

Humberto Castellanos Sinco, PhD

First Name & Middle Initial & Last Name & Degree

Odín de la Mora Estrada, PhD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

31475812

Citation

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.

Results Reference

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PubMed Identifier

30524673

Citation

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.

Results Reference

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PubMed Identifier

30472427

Citation

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.

Results Reference

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

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