StrainsPhase 4NCT05133310
Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia
A Phase 4 study testing Simvastatin in people with Strains and Acute Lymphoblastic Leukemia, run by Hospital General de Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Strains, Acute Lymphoblastic Leukemia, Sepsis
- What is being tested?
- Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteMexico
- Study dates
- 19 Nov 2021to 23 Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de México "Dr. Eduardo Liceaga"
Mexico City, 06720
Christian O Ramos Peñafiel, PhD, +52 55 2789 2000 ext. 2020, leukemiachop@hotmail.com
Adan G Gallardo-Rodriguez, MSc, +52 55 2789 2000 ext. 2020, nutriologo.agallardo8@gmail.com
About this study
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.
Read the 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
- Being tested
- Simvastatin
- Keywords
- Acute lymphoblastic leukemia, Sepsis, Febrile Neutropenia, Simvastatin
- Medical subject headings
- Sprains and Strains, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Sepsis, Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinDrug
Also called Intervention Group
Combination of Simvastatin with Standard Chemotherapy scheme for acute lymphoblastic patients.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Discharge
The event in which patient is discharge from Hospital stay,
Measured: 3 months
Feverish Event
Determination of a temperature above 38 ° persistently for more than 30 minutes
Measured: 3 months
Sepsis
Presence of hemodynamic alterations characterized by persistent hypotension, elevated heart rate, fever, and abnormal respiration
Measured: 3 months
Neutrophils count
Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle
Measured: 3 months
Platelets count
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Measured: 3 month
Blasts in marrow
Presence of more than 5% of blasts in bone marrow after each chemotherapy cycle
Measured: 3 month
Neutrophil recovery time
Time in days for neutrophil recovery
Measured: 1 month
Secondary outcomes (3)
Bacterial isolation
Description of the germ isolated in cultures during follow-up
Measured: 3 months
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
Measured: 3 months
Hospital Stay
Measurement of days of hospital stay
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start19 Nov 2021
- Primary completion16 Dec 2022 (estimated)
- Study completion23 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StrainsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinical randomized trial
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Christian Omar Ramos-Peñafiel, MD, PhD, Hospital General de Mexico
- Investigators
- Adolfo Martinez Tovar, PhD, Study director, Hospital General de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133310
- Sponsor's protocol ID
- HGMDI/21/204/03/63
- Status last verified
- Jan 2022
- First submitted
- 15 Nov 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.
Publications
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.
PubMed 31475812Pirzad 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.
PubMed 30524673Pertzov 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.
PubMed 30472427
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simvastatin on Sepsis and Febrile Neutropenia in Patients With Acute Lymphoblastic Leukemia
- ClinicalTrials.gov ID
- NCT05133310
- Acronym / sponsor ID
- HGMDI/21/204/03/63
- Conditions
- Strains, Acute Lymphoblastic Leukemia, Sepsis
- Keywords
- Acute lymphoblastic leukemia, Sepsis, Febrile Neutropenia, Simvastatin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Hospital General de MexicoOther government
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- 16 Dec 2022 (estimated)
- Study completion
- 23 Jun 2023 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Clinical randomized trial
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: SimvastatinPatients 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimvastatinAlso: Intervention GroupCombination of Simvastatin with Standard Chemotherapy scheme for acute lymphoblastic patients. | Drug | Simvastatin Treatment Group |
Primary outcome
Hospital Discharge
Time frame: 3 months
The event in which patient is discharge from Hospital stay,
Feverish Event
Time frame: 3 months
Determination of a temperature above 38 ° persistently for more than 30 minutes
Sepsis
Time frame: 3 months
Presence of hemodynamic alterations characterized by persistent hypotension, elevated heart rate, fever, and abnormal respiration
Neutrophils count
Time frame: 3 months
Number of neutrophils found in peripheral blood at the end of each chemotherapy cycle
Platelets count
Time frame: 3 month
Number of platelets found in peripheral blood at the end of each chemotherapy cycle
Blasts in marrow
Time frame: 3 month
Presence of more than 5% of blasts in bone marrow after each chemotherapy cycle
Neutrophil recovery time
Time frame: 1 month
Time in days for neutrophil recovery
3 secondary outcomes
Bacterial isolation
Time frame: 3 months
Procalcitonin
Time frame: 3 months
Hospital Stay
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Background: PubMed 31475812Escrihuela-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.
- Background: PubMed 30524673Pirzad 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.
- Background: PubMed 30472427Pertzov 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.
- Individual participant dataSharing planned: No. All participants and their information will be managed by intern investigators and will be kept secure for personal data protection according to Mexican laws.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adolfo Martinez Tovar, PhD study director
Hospital General de Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Simvastatin in people with Strains and Acute Lymphoblastic Leukemia, run by Hospital General de Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian O Ramos Peñafiel, PhD (+52 55 27892000 ext. 2020, leukemiachop@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Discharge (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05133310, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.