Clinical Trials /

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

NCT02531308

Description:

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)

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: LYM2014-MET-R-CHOP
  • NCT ID: NCT02531308

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

DrugSynonymsArms
MetforminGlucophage, Glucophage XR, Glumetza, Fortamet, Riomet.R-CHOP with Metformin
RituximabRituxan, Zytux, Mab theraR-CHOP with Metformin
CyclophosphamideEndoxan, Cytoxan, Neosar, Procytox, Revimmune, CycloblastinR-CHOP with Metformin
DoxorubicinAdriamycinR-CHOP with Metformin
VincristineOncovinR-CHOP with Metformin
PrednisoneDeltasoneR-CHOP with Metformin
pegfilgrastimNeulastaR-CHOP with Metformin

Purpose

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)

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.
    

Trial Arms

NameTypeDescriptionInterventions
R-CHOP with MetforminExperimentalRituximab 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.
  • Metformin
  • Rituximab
  • Cyclophosphamide
  • Doxorubicin
  • Vincristine
  • Prednisone
  • pegfilgrastim

Eligibility 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.

             -
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival
Time Frame:2 year
Safety Issue:
Description:rate of progression in patients 2 years after diagonosis

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Rush University Medical Center

Trial Keywords

  • diffuse large b-cell lymphoma (DLBCL),
  • lymphoma

Last Updated

January 27, 2017