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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | Combination of Simvastatin with Standard Chemotherapy scheme for acute lymphoblastic patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial isolation | Description of the germ isolated in cultures during follow-up | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian O Ramos Peñafiel, PhD | Contact | +52 55 27892000 | 2020 | leukemiachop@hotmail.com |
| Adan G Gallardo Rodriguez, MSc | Contact | +52 55 27892000 | 2020 | nutriologo.agallardo8@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Adolfo Martinez Tovar, PhD | Hospital General de Mexico | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General de México "Dr. Eduardo Liceaga" | Recruiting | Mexico City | 06720 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31475812 | Background | 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. | |
| 30524673 | Background | 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. |
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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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| ID | Term |
|---|---|
| D013180 | Sprains and Strains |
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D018805 | Sepsis |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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Clinical randomized trial
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| 3 months |
| Hospital Stay | Measurement of days of hospital stay | 1 month |
| 30472427 | Background | 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. |
| D009369 |
| Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |