Chronic myeloproliferative disease Myeloproliferative Disorders
Conditions
Interventions
This is a randomized, controlled, open-label clinical trial with two arms, involving a total of 30 participants, 20 of whom will be treated with metformin and 10 of whom will receive no treatment. Pat
s resources. Recognizing that the absence of masking may introduce performance and measurement biases, strict measures will be taken to minimize this risk. Primary outcomes will be objective and measu
Sponsors
Centro de Hematologia e Hemoterapia da Unicamp – Hemocentro da UNICAMP
Centro de Hematologia e Hemoterapia da Unicamp – Hemocentro da UNICAMP
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Eligible patients will be those diagnosed with myeloproliferative neoplasm (MPN) according to WHO criteria confirmed by at least two independent specialists, diagnosed with primary myelofibrosis (PMF) or transformation to secondary myelofibrosis (post-PV or post-TE), confirmed by bone marrow biopsy, and aged = 18 years.
Exclusion criteria
Exclusion criteria: Significant hepatic or renal dysfunction, typically defined as aspartate and alanine aminotransferase levels greater than 2.5 times the upper limit of normal, total bilirubin above 3.0 mg/dL, or serum creatinine above 3.0 mg/dL; hypersensitivity to biguanide, uncontrolled diabetes mellitus, untreated vitamin B12 deficiency, pregnancy, severe psychiatric disorders, and use of anagrelide and/or ruxolitinib in the sixty days prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in the level of bone marrow fibrosis is expected after treatment with metformin, verified through serial bone marrow biopsies with reticulin and second harmonic staining; based on the findings of anatomopathological analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| An improvement in the hematimetric parameters observed through blood counts is expected, based on the finding of a statistically significant difference between the groups (treated and untreated) in the pre- and post-intervention variation;A lower transfusion requirement is expected, based on the finding of a statistically significant difference between the groups (treated and untreated) in the pre- and post-intervention variation;A reduction in hepatosplenomegaly is expected to be found through abdominal tomography based on the observation of a statistically significant difference between the groups (treated and untreated) in the pre- and post-intervention variation;A reduction in the phosphorylation level of JAK 2, STAT 3, and STAT5 is expected to be found by flow cytometry and immunohistochemistry based on the observation of a statistically significant difference between the groups (treated and untreated) in the pre- and post-intervention variation ; It is expected to find a lower expression of genes related to inflammatory pathways or bone marrow fibrosis inducers in the transcriptome, based on the finding of a statistically significant difference between the groups (treated and untreated) in the pre- and post-intervention variation ;An improvement in the score of the Questionnaire for the assessment of symptoms in myeloproliferative neoplasms is expected based on the finding of a statistically significant difference between the groups (treated and untreated) in the pre- and post-intervention variation | — |
Countries
BR
Contacts
Public ContactMurilo Lutfi
Centro de Hematologia e Hemoterapia da Unicamp – Hemocentro da UNICAMP
Outcome results
None listed