Clinical trial · Interventional
Metformin Reduce the Relapse Rate on Patients With B-cell Precursor (Ph+ Negative) Acute Lymphoblastic Leukemia
Effect of the Addition of Metformin Hydrochloride on the Prognosis of Patients With B-cell Precursor (Ph+ Negative) Acute Lymphoblastic Leukemia With High Expression of ABCB1 Gene
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- metformin
- description
- Metformin 850mg PO three times a day, during the pre-induction with steroids, induction remission, consolidation and maintenance
- interventionNames
- Drug: Metformin
- type
- NO_INTERVENTION
- label
- No metformin
Primary outcomes (2)
- measure
- Effect of Metformin on first line treatment Refractoriness in high risk failure ALL patients
- timeFrame
- 28 day induction remission treatment
- description
- Effect on the refractoriness frequency in high risk failure patients (High levels of ABCB1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDKim HG, Hien TT, Han EH, Hwang YP, Choi JH, Kang KW, Kwon KI, Kim BH, Kim SK, Song GY, Jeong TC, Jeong HG. Metformin inhibits P-glycoprotein expression via the NF-kappaB pathway and CRE transcriptional activity through AMPK activation. Br J Pharmacol. 2011 Mar;162(5):1096-108. doi: 10.1111/j.1476-5381.2010.01101.x. PMID 21054339
- BACKGROUNDOlarte Carrillo I, Ramos Penafiel C, Miranda Peralta E, Rozen Fuller E, Kassack Ipina JJ, Centeno Cruz F, Garrido Guerrero E, Collazo Jaloma J, Nacho Vargas K, Martinez Tovar A. Clinical significance of the ABCB1 and ABCG2 gene expression levels in acute lymphoblastic leukemia. Hematology. 2017 Jun;22(5):286-291. doi: 10.1080/10245332.2016.1265780. Epub 2016 Dec 14. PMID 27960630
- DERIVEDRamos-Penafiel C, Olarte-Carrillo I, Ceron-Maldonado R, Rozen-Fuller E, Kassack-Ipina JJ, Melendez-Mier G, Collazo-Jaloma J, Martinez-Tovar A. Effect of metformin on the survival of patients with ALL who express high levels of the ABCB1 drug resistance gene. J Transl Med. 2018 Sep 3;16(1):245. doi: 10.1186/s12967-018-1620-6. PMID 30176891