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Biguanide

Metformin for Chronic Lymphocytic Leukemia

Phase 2
Waitlist Available
Led By Sami Malek, MD
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any increase in lymphadenopathy over best response that has persisted for more than 3 months
Patients who relapse after receiving a one or more courses of fludarabine, bendamustine, cytoxan, rituxan, chlorambucil, or campath based therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 3 months after completing metformin therapy
Awards & highlights

Study Summary

This trial will study whether metformin is an effective treatment for people with CLL.

Who is the study for?
This trial is for adults aged 18-79 with relapsed or untreated chronic lymphocytic leukemia (CLL) who have specific blood cell counts and markers. They must not have diabetes, be taking certain diabetes medications, or require urgent chemotherapy. Participants need to be in stable health without severe heart failure or a history of allergic reactions to metformin.Check my eligibility
What is being tested?
The study tests Metformin, commonly used for diabetes, on CLL patients. It explores how Metformin affects cancer cells by improving insulin sensitivity and activating pathways that may inhibit cancer growth. This pilot trial aims to see if it's safe and effective in treating CLL.See study design
What are the potential side effects?
Metformin is generally well-tolerated but can cause digestive issues like nausea and diarrhea. There's a rare risk of lactic acidosis, especially if kidney function is impaired or in the presence of other risk factors such as severe infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lymph nodes have been swollen for more than 3 months.
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My condition worsened after treatment with specific cancer drugs.
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I am between 18 and 79 years old.
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I have an untreated del11q mutation.
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My kidney function is normal or only mildly reduced.
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My cancer cells test positive for CD19 or CD20, and also for CD23 and CD5.
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I have been diagnosed with chronic lymphocytic leukemia.
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I am able to care for myself and move around.
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My organs are functioning normally.
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My kidney function, measured by serum creatinine, is within the normal range.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 3 months after completing metformin therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 3 months after completing metformin therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to treatment failure
Secondary outcome measures
Change in number of clinically appreciated lymphadenopathy and splenomegaly while on metformin therapy
Splenomegaly
Changes in the rate of increase of absolute lymphocyte count while on metformin therapy
+1 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

1Treatment groups
Experimental Treatment
Group I: Metformin (Glucophage)Experimental Treatment1 Intervention
The starting dose of metformin will be 500 mg po daily for one week. The dose can be escalated to 500 mg twice a day after one week, and further escalated to the final dose of 1000 mg twice a day in week 3 if the medication is tolerated without adverse side effects (refer to holding parameters described in section 9.3.3). All doses should be administered with food to decrease gastrointestinal upset.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430

Find a Location

Who is running the clinical trial?

University of Michigan Rogel Cancer CenterLead Sponsor
292 Previous Clinical Trials
24,080 Total Patients Enrolled
Sami Malek, MDPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center

Media Library

Metformin (Biguanide) Clinical Trial Eligibility Overview. Trial Name: NCT01750567 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Metformin (Glucophage)
Chronic Lymphocytic Leukemia Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT01750567 — Phase 2
Metformin (Biguanide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01750567 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Metformin been granted regulatory sanction by the FDA?

"Due to the Phase 2 status of Metformin, our team at Power has assigned it a safety rating of 2 out of 3 due to limited efficacy data."

Answered by AI

To what extent are potential participants eligible for this research endeavor?

"Eligibility for this medical trial calls for patients with leukemia that are between 18 and 80 years old. 40 people in total need to be enrolled."

Answered by AI

Does this research protocol include participants aged 40 and beyond?

"This medical trial seeks participants who are between 18 years old and their octogenarian birthday."

Answered by AI

Is there evidence of Metformin being utilized in prior research projects?

"Presently, 170 Metformin clinical trials are ongoing. Of those, 43 have reached Phase 3 and the majority of them occur in Rockville, Maryland. Across 1903 sites across the US though, researchers can conduct studies on Metformin's efficacy."

Answered by AI

What is the total enrollment tally for this medical trial?

"Affirmative. Clinicaltrials.gov contains evidence that this clinical trial is actively recruiting 40 patients from 1 site, having been initially posted on November 1st 2012 and recently edited on May 11th 2022."

Answered by AI

What ailments typically respond positively to Metformin treatment?

"Exercise-related conditions can frequently be managed with Metformin; however, it is also beneficial for treating other medical complications including type 1 diabetes mellitus, diabetic ketoacidosis, and polycystic ovary syndrome."

Answered by AI

Is this experiment still open to participants?

"Current information on clinicaltrials.gov confirms that this medical study is actively recruiting subjects for participation. This trial was first listed online on November 1st, 2012 and its details were last updated on May 11th, 2022."

Answered by AI
~0 spots leftby May 2024