Lymphoma, Large B-Cell, DiffusePhase 2NCT03600363
A Clinical Trial of Metformin in the Maintenance of Non-Hodgkin's Lymphoma Patients
A Phase 2 study testing Metformin in people with Lymphoma, Large B-Cell, Diffuse and Stage III Follicular Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse, Stage III Follicular Lymphoma
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2018to Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Phase II Clinical Trial of Metformin in the Maintenance Therapy of High Risk Diffuse Large B Lymphoma / Stage III Follicular Lymphoma Patients With Complete Remission
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
- Being tested
- Metformin, Placebos
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
metformin (1.0g, bid) as a maintenance therapy in patients with complete remission
PlacebosDrug
oral placebos as a maintenance therapy
| Study group | Role | What they receive |
|---|---|---|
| metformin arm | Experimental | Not described Receives: Drug: Metformin |
| control arm | Placebo comparator | Not described Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Measured: 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
Measured: From date of randomization until the date of trail closed or disease progressed, whichever came first, up to 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Sep 2018
- Primary completionJan 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600363
- Sponsor's protocol ID
- RJ-NHL-1805
- Status last verified
- Mar 2020
- First submitted
- 17 Jul 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Phase II Clinical Trial of Metformin in the Maintenance Therapy of High Risk Diffuse Large B Lymphoma / Stage III Follicular Lymphoma Patients With Complete Remission
- ClinicalTrials.gov ID
- NCT03600363
- Acronym / sponsor ID
- RJ-NHL-1805
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| metformin arm | Experimental | Drug: Metformin |
| control arm | Placebo comparator | Drug: Placebos |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metforminmetformin (1.0g, bid) as a maintenance therapy in patients with complete remission | Drug | metformin arm |
| Placebosoral placebos as a maintenance therapy | Drug | control arm |
Primary outcome
Overall Survival
Time frame: From date of randomization until the date of trail closed or date of death from any cause, whichever came first, up to 100 months
1 secondary outcome
Progress Free Survival
Time frame: From date of randomization until the date of trail closed or disease progressed, whichever came first, up to 100 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
Related trials for Lymphoma, Large B-Cell, Diffuse
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metformin in people with Lymphoma, Large B-Cell, Diffuse and Stage III Follicular Lymphoma, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao Zhao (64370045 ext. 610707, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From date of randomization until the date of trail closed or date of death from any cause, whichever came first, up to 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020.