Metformin Reduce the Relapse Rate on Patients With B-cell Precursor (Ph+ Negative) Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 2017-04-30
• Target enrollment: 0
• Participant gender: All

Summary

Metformin's Antitumor activity were identified from differens diabetic patients trials, mainly associated to its mechanism of action and protein - kinase AMPK (AMP-activated protein kinase) activation. According to Cancer and Diabetes International Consensus from 2012, diabetes increases the risk for developping cancer and metformin has an protector effect against cancer cells and has an impact on overall survival.

Chemotherapy drug resistance induces treatment fail in oncology. Metformin increases AMPK levels, blocks PI3K (phosphatidylinositol 3- kinase)/ AKT /mTOR(mammailian Target of Rapamycin) pathway but few evidence associated with drug resistance gene expression.

This is an, experimental one-center study that pretends to stablish the effect of adding metformin 850 mg PO three times a day over the multi-drug resistance gene expression (ABCB1) in de novo Acute Lymphoblastic Leukemia in one 7-days cycle with prednisone as pre-treatment- and on the induction remission treatment.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital General de Mexico
• Treatments: Metformin

Criteria

Inclusion Criteria:

• > 18 years

• de novo B-cell precursor Acute Lymphoblastic Leukemia

• candidates to first line treatment protocol

• ECOG (Eastern Cooperative Oncology Group) Scale of Performance Status 1/2

• Informed Consent Form for genetic analysis samples

• Precursor B Cell Acute Lymphoblastic Leukemia

Exclusion Criteria:

• Diagnose of Acute Myelogenous Leukemia or Biphenotype Leukemia

• Diagnose of type 2 Diabetes Mellitus

• Previous use of Metformin

• Relapsed Acute Leukemia that require treatment protocol to be started

• Intolerance to prednisone

• ECOG Scale of Performance Status 3/4

• T-cell Acute Lymphoblastic Leukemia

• Philadelphia positive Acute Lymphoblastic Leukemia

• Tumor lysis syndrome at diagnose

• Renal Failure (creatinine leve higher than 2mg/dl)

• Several liver damage (>2 levels de upper normal limit of Aspartate transaminase (AST) and alanine transaminase (ALT)

• Metabolic Acidosis or Lactic Acidosis at diagnose

• Central nervous system infiltration at diagnose

• Extramedullary disease (skin, pleura,eye)

• Active GI bleeding