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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.

Must not have

Currently taking metformin, sulfonylureas, thiazolidinediones or insulin for any reason

Known diabetes (type 1 or 2), fasting glucose > or equal to 7.0 mmol/L (126 mg/dL), or HgbA1C > 6.5

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 3 months after completing metformin therapy

Awards & highlights

No Placebo-Only Group

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.

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.

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication for diabetes.

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I have diabetes with high blood sugar or HgbA1C levels.

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I need urgent chemotherapy for my active CLL.

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I received my last treatment for CLL less than 30 days ago.

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I am not pregnant nor planning to become pregnant, confirmed by a test.

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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

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I have had metabolic acidosis in the past.

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I do not have an active infection that could lead to sepsis.

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I have severe heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 3 months after completing metformin therapy

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to treatment failure

Secondary study objectives

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

Hunger

Tremor

Asthenia

Hypoglycaemia

Femoral neck fracture

Squamous cell carcinoma of the tongue

100%

80%

60%

40%

20%

Study treatment Arm

Vildagliptin (LAF237)

Placebo

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 18Eligibility criteria met