NCT03600363

Brief Summary

The study is to evaluate the therapeutic effect of metformin as a maintenance therapy in high risk patients with complete remission of diffuse large B lymphoma / stage III follicular lymphoma after chemotherapy in the initial R-CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone, plus the monoclonal antibody rituximab) regimen

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

July 17, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 11, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

July 17, 2018

Last Update Submit

March 9, 2020

Conditions

Lymphoma, Large B-Cell, DiffuseStage III Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    From date of randomization until the date of trail closed or date of death from any cause, whichever came first, up to 100 months

Secondary Outcomes (1)

  • Progress Free Survival

    From date of randomization until the date of trail closed or disease progressed, whichever came first, up to 100 months

Study Arms (2)

metformin arm

EXPERIMENTAL
Drug: Metformin

control arm

PLACEBO COMPARATOR
Drug: Placebos

Interventions

MetforminDRUG

metformin (1.0g, bid) as a maintenance therapy in patients with complete remission

metformin arm
PlacebosDRUG

oral placebos as a maintenance therapy

control arm

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patient age \>14 years old;
  • Pathological types include: diffuse large B lymphoma, and stage III follicular lymphoma;
  • At the initial stage of therapy, received standard R-CHOP regimen and complete remission after the first course of treatment;
  • After complete remission, not consider to receive hematopoietic stem cell transplantation or chimeric antigen receptor T cell immunotherapy;
  • Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) not exceed 2 times of the normal upper limit;
  • Serum total bilirubin and creatinine not exceed 1.5 times of the normal upper limit;
  • Serum creatinine not exceed 1.5mg/dl;
  • Patients with high risk factors, including age \> 60 year, or with diabetes/ impaired glucose tolerance, or with International Prognostic Index (IPI) score ≥2.
  • Sign informed consent file.

You may not qualify if:

  • Past medical history of high doses of cytarabine, methotrexate and rituximab maintenance therapy;
  • Past medical history of any type of hematopoietic stem cell transplantation;
  • Past medical history of lactic acidosis;
  • Extreme weight loss failure, malnutrition or dehydration patients;
  • Pregnant women or lactating women, or women who do not take contraceptive measures for childbearing age;
  • Alopecia, mental retardation or psychiatric disorders that affect the patient's normal informed consent;
  • Type 1.2 diabetes with ketoacidosis, liver function or renal insufficiency, pulmonary insufficiency, heart failure, acute myocardial infarction, severe infection and trauma, major surgery and clinical hypotension or hypoxia;
  • Diabetes complicated with severe chronic complications (such as diabetic nephropathy, diabetic retinopathy);
  • Any other serious complications occurred, depending on the outcome of the study;
  • Before the intravenous pyelography or anterior angiography;
  • Alcoholics;
  • Deficiency of Vitamin B12, folic acid or iron.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Large B-Cell, DiffuseLymphoma, Follicular

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

Central Study Contacts

Weili Zhao Zhao

CONTACT

64370045zhao.weili@yahoo.com

Xing Fan

CONTACT

64370045fx-86@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director of Hematology Department

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

September 1, 2018

Primary Completion

January 1, 2021

Study Completion

December 1, 2021

Last Updated

March 11, 2020

Record last verified: 2020-03

Locations

CN(1)