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

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ClinicalTrials.gov Identifier: NCT03118128
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : July 6, 2017
Sponsor:
Information provided by (Responsible Party):
Christian Ramos Penafiel, Hospital General de Mexico

Brief 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.


Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: Metformin Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : January 1, 2015
Actual Primary Completion Date : December 1, 2016
Actual Study Completion Date : April 30, 2017


Arm Intervention/treatment
Active Comparator: metformin
Metformin 850mg PO three times a day, during the pre-induction with steroids, induction remission, consolidation and maintenance
Drug: Metformin
Metformin 850 mg PO three times a day plus prednisone in one 7-days cycle as pre-treatment and during the 28 days induction remission treatment, consolidation therapy and maintenance

No Intervention: No metformin



Primary Outcome Measures :
  1. Effect of Metformin on first line treatment Refractoriness in high risk failure ALL patients [ Time Frame: 28 day induction remission treatment ]
    Effect on the refractoriness frequency in high risk failure patients (High levels of ABCB1)

  2. Effect of Metformin on relapse rate and survival of high risk failure ALL patients [ Time Frame: 12 months of follow up ]
    Effect of Metformin on Relapse Free Survival (RFS) on patients with high risk failure (high levels of ABCB1 gene )



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christian Ramos Penafiel, Principal Investigator, Hospital General de Mexico
ClinicalTrials.gov Identifier: NCT03118128     History of Changes
Other Study ID Numbers: HGM-CRP2-LLA
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: July 6, 2017
Last Verified: April 2017

Keywords provided by Christian Ramos Penafiel, Hospital General de Mexico:
Acute Lymphoblastic Leukemia (ALL), ABCB1, Metformin

Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs