NCT03200015

Brief Summary

Evaluation of the safety and effectiveness of metformin as an adjunct to RCHOP chemotherapy for patients with newly diagnosed diffuse large-B cell lymphoma

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2019

Completed
Last Updated

November 7, 2022

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

May 24, 2017

Last Update Submit

November 3, 2022

Conditions

Diffuse Large B Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

  • Incidence of treatment-emergent adverse events

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    6 months

  • Response rates

    Overall, partial and complete responses to chemoimmunotherapy

    6 months

Secondary Outcomes (4)

  • Progression-free survival

    2-5 years

  • Overall survival

    2-5 years

  • Event-free survival

    2-5 years

  • Time to progression or relapse

    2-5 years

Study Arms (1)

Metformin arm

EXPERIMENTAL

Metformin 850 mg tablets. Initial dose 425 mg twice a day for 1 week, followed by 850 mg twice a day for 1 week, titrated to a maximum dose 850 mg every 8 hours until disease response evaluation study date (Computed tomography or positron emission tomography)

Drug: Metformin

Interventions

MetforminDRUG

Potentially increasing the efficacy and safety of standard chemotherapy through several mechanisms

Metformin arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with newly diagnosed nodal diffuse large-B cell non Hodgkin lymphoma according to the 2008 World Health Organization classification for lymphoid malignancies
  • No previous treatment other than prednisone or equivalent glucocorticoid up to 60 mg/m2 for 14 days
  • Good performance status (Eastern Cooperative Oncology Group scale 0-2)
  • Life expectancy \>6 months
  • Independently of the diagnosis of diabetes mellitus (any type)

You may not qualify if:

  • History of intolerance or hypersensitivity reactions to metformin
  • Primary central nervous system lymphoma
  • History of other previous malignant neoplastic diseases \<5 years prior to enrollment
  • Evidence of systemic infection at the time of study
  • HIV, hepatitis C or B virus infection
  • Aspartate transaminase or alanine transaminase \>2x upper limit of normal, bilirubin \>2.5 times upper limit of normal
  • Serum creatinine \>1.5 mg/dL or chronic renal disease
  • Cardiac insufficiency (New York Heart Association scale \>1 or ejection fraction \<50%)
  • History of transformation from an indolent lymphoma
  • Pregnancy
  • History of lactic acidosis or alcoholism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64610, Mexico

Location

Related Publications (3)

  • Asensio-Lopez MC, Lax A, Pascual-Figal DA, Valdes M, Sanchez-Mas J. Metformin protects against doxorubicin-induced cardiotoxicity: involvement of the adiponectin cardiac system. Free Radic Biol Med. 2011 Nov 15;51(10):1861-71. doi: 10.1016/j.freeradbiomed.2011.08.015. Epub 2011 Aug 25.

    PMID: 21907790BACKGROUND

  • Shi WY, Xiao D, Wang L, Dong LH, Yan ZX, Shen ZX, Chen SJ, Chen Y, Zhao WL. Therapeutic metformin/AMPK activation blocked lymphoma cell growth via inhibition of mTOR pathway and induction of autophagy. Cell Death Dis. 2012 Mar 1;3(3):e275. doi: 10.1038/cddis.2012.13.

    PMID: 22378068BACKGROUND

  • Alkhatib Y, Abdel Rahman Z, Kuriakose P. Clinical impact of metformin in diabetic diffuse large B-cell lymphoma patients: a case-control study. Leuk Lymphoma. 2017 May;58(5):1130-1134. doi: 10.1080/10428194.2016.1239822. Epub 2016 Oct 5.

    PMID: 27701994BACKGROUND

Related Links

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Interventions

Metformin

Condition Hierarchy (Ancestors)

Lymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • David Gómez-Almaguer, MD

    Hospital Universitario Dr. José Eleuterio González

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 24, 2017

First Posted

June 27, 2017

Study Start

October 1, 2017

Primary Completion

August 27, 2018

Study Completion

January 27, 2019

Last Updated

November 7, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

No plans for a sharing plan pre-determined

Locations

ME(1)