Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Metformin in Combination With Standard Induction Therapy for Large B-cell Lymphoma (DLBCL) (DLBCL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02531308
Recruitment Status : Terminated (poor accrual)
First Posted : August 24, 2015
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
Evaluation of impact of metformin on 2 year progression-free survival (PFS) rate in subjects with previously untreated DLBCL when added to standard induction therapy. (R-CHOP)

Condition or disease Intervention/treatment Phase
Diffuse Large B-Cell Lymphoma Drug: Metformin Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: pegfilgrastim Phase 2

Detailed Description:

Newly diagnosed histologically confirmed CD20 positive previously untreated diffuse large B-cell lymphoma to receive up to 4-6 cycles (21 day cycles) of:

R-CHOP: Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 IV Day 1 (cap @ 2mg) Prednisone 100mg PO daily Days 1-5 Pegfilgrastim 6 mg subcutaneously within 72 if start if cycle Metformin 500 mg PO daily Cycle 1 Days 1-7 Metformin 500 mg PO twice daily Cycle 1 Days 7-21 Metformin 850 mg PO twice daily starting on day 22 and and continuing throughout remainder of cycles plus 22 days post treatment.

Restaging will be done after the 4th cycle is complete. Subjects will be monitored with labs and physical exams throughout the study.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase ll Study Evaluating the Efficacy and Safety of Metformin in Combination With Standard Induction Therapy (RM-CHOP) for Previously Untreated Aggressive Diffuse Large B-cell Lymphoma
Study Start Date : July 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016


Arm Intervention/treatment
Experimental: R-CHOP with Metformin

Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.

Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.

Drug: Metformin
Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.
Other Name: Glucophage, Glucophage XR, Glumetza, Fortamet, Riomet.

Drug: Rituximab
monoclonal antibody against protein CD20 primarily found on the surface of B-cells
Other Name: Rituxan, Zytux, Mab thera

Drug: Cyclophosphamide
Interferes with DNA replication
Other Name: Endoxan, Cytoxan, Neosar, Procytox, Revimmune, Cycloblastin

Drug: Doxorubicin
anthracycline antitumor antibiotic
Other Name: Adriamycin

Drug: Vincristine
Inhibits cell mitosis causing cell death.
Other Name: Oncovin

Drug: Prednisone
a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug. It is used to treat certain inflammatory diseases
Other Name: Deltasone

Drug: pegfilgrastim
stimulates the level of white blood cells (neutrophils).
Other Name: Neulasta




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 2 year ]
    rate of progression in patients 2 years after diagonosis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of Diffuse Large B-cell Lymphoma (DLBCL) as documented by medical records and with histology based on criteria established by the World Health Organization

    a. subtyping is required for DLBCL

  2. No prior therapy for diagnosis of DLBCL
  3. Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of equal to or greater than 1 lesion that measures >1.5 cm in the longest diameter and > 1.0 cm in the longest perpendicular diameter assessed by CT or MRI) or bone marrow involvement
  4. Eastern Cooperative Oncology Group performance score of 0-2
  5. Life expectancy of at least 6 months
  6. No history of medication dependent diabetes mellitus
  7. Required screening laboratory data (within 4 weeks prior to start of study drug) -

Exclusion Criteria:

  1. Patients already on any class of anti-diabetic medication including metformin, insulin analogues, sulfonylureas, thiazolidinediones (TZDs) and the incretin-based therapies or clear need for therapeutic intervention based on fasting blood glucose
  2. Known histological transformation from indolent non-Hodgkins Lymphoma (NHL) or chronic lymphocytic leukemia (CLL) to an aggressive form of NHL (ie, Richter transformation)
  3. Double or triple hit lymphomas
  4. Known active cent4ral nervous system or leptomeningeal lymphoma
  5. Presence of known intermediate or high-grade myelodysplastic syndrome
  6. History of a non-lymphoid malignancy within the last 3 years (see protocol for exceptions)
  7. Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study
  8. Ongoing, drug-induced liver injury, chronic active Hepatitis C Virus (HCV), chronic active Hepatitis B Virus (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
  9. HIV positive
  10. Ongoing inflammatory bowel disease
  11. Ongoing alcohol or drug addiction
  12. Pregnancy
  13. History of prior allogeneic bone marrow progenitor cell or solid organ transplantation.

    -


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): NCT02531308


Locations
Layout table for location information
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Reem Karmali, MD Assistant Professor of Medicine
Layout table for additonal information
Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02531308    
Other Study ID Numbers: LYM2014-MET-R-CHOP
First Posted: August 24, 2015    Key Record Dates
Results First Posted: January 27, 2017
Last Update Posted: January 27, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Rush University Medical Center:
diffuse large b-cell lymphoma (DLBCL),
lymphoma
Additional relevant MeSH terms:
Layout table for 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
Prednisone
Cyclophosphamide
Rituximab
Doxorubicin
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Hypoglycemic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors