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Rituximab, Cyclophosphamide, Vincristine and Prednisone (R-CHOP) Plus Metformin in Diffuse Large-B-cell Lymphoma

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ClinicalTrials.gov Identifier: NCT03200015
Recruitment Status : Recruiting
First Posted : June 27, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
David Gomez Almaguer, Hospital Universitario Dr. Jose E. Gonzalez

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

Condition or disease Intervention/treatment Phase
Diffuse Large B Cell Lymphoma Drug: Metformin Phase 2

Detailed Description:

Patients with newly diagnosed diffuse large-B cell non Hodgkin lymphoma, irrespective of cell of origin status will receive metformin in combination to Rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (RCHOP) chemotherapy for 6 cycles, until response evaluation as reported elsewhere:

1.- Rituximab 375 mg/m2 IV, day 1. 2.- Cyclophosphamide 750 mg/m2 IV, day 1. 3.- Doxorubicin 50 mg/m2 IV day 1. 4.- Vincristine 1.4 mg/m2 IV (2 mg maximum dose). 5.- Prednisone 60 mg/m2 PO days 1-5. Six cycles every 21 days.

Metformin will be added and administered in an outpatient basis, starting with 425 mg twice a day for 1 week, followed by 850 mg twice a day for 1 week, and lastly 850 mg every 8 hours maximum dose until re-staging. Laboratory tests will be performed serially.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Metformin in Combination With R-CHOP for the First Line Treatment of Patients With Diffuse Large B-cell Lymphoma
Estimated Study Start Date : October 1, 2017
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : August 31, 2020


Arm Intervention/treatment
Experimental: Metformin arm
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
Potentially increasing the efficacy and safety of standard chemotherapy through several mechanisms



Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: 6 months ]
    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  2. Response rates [ Time Frame: 6 months ]
    Overall, partial and complete responses to chemoimmunotherapy


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 2-5 years ]
    Survival with freedom from progression

  2. Overall survival [ Time Frame: 2-5 years ]
    Survival from diagnosis until death or last follow-up

  3. Event-free survival [ Time Frame: 2-5 years ]
    Survival from diagnosis until death or progression

  4. Time to progression or relapse [ Time Frame: 2-5 years ]
    Time from diagnosis until disease progression or relapse



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200015


Contacts
Contact: César H Gutiérrez-Aguirre, MD +528183486136 hematohu@yahoo.com.mx
Contact: Andres Gómez-De León, MD +528183486136 drgomezdeleon@gmail.com

Locations
Mexico
Hospital Universitario Dr. José Eleuterio González Recruiting
Monterrey, Nuevo Leon, Mexico, 64610
Contact: Andres Gómez-De Leon, MD    +528183486136    drgomezdeleon@gmail.com   
Sponsors and Collaborators
Hospital Universitario Dr. Jose E. Gonzalez
Investigators
Study Chair: David Gómez-Almaguer, MD Hospital Universitario Dr. José Eleuterio González

Additional Information:
Publications:
Responsible Party: David Gomez Almaguer, MD, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT03200015     History of Changes
Other Study ID Numbers: HE16-00019
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plans for a sharing plan pre-determined

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs