Metformin for Chronic Lymphocytic Leukemia

Recruiting in Palo Alto (17 mi)

Overseen bySami Malek, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Michigan Rogel Cancer Center

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?Metformin is an antidiabetic drug which is an inexpensive and generally well tolerated medication. More recently metformin has been shown to act against carcinomas by two mechanisms: 1) an indirect, insulin-dependent mechanism which sensitizes tissues to insulin, inhibits hepatic gluconeogenesis, and stimulates uptake of glucose in muscle, thereby reducing fasting blood glucose and circulating levels of insulin, lowering the pro survival activity of the insulin/INSR axis, and 2) a direct, insulin-independent mechanism which activates the AMP-activated protein kinase (AMPK) pathway and leads to inhibition of the mTOR pathway. Given the investigators preliminary published data on insulin and mTOR inhibition\[1\] metformin is an attractive candidate for a pilot clinical trial in CLL patients.

Eligibility Criteria

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.

Inclusion Criteria

My lymph nodes have been swollen for more than 3 months.

My condition worsened after treatment with specific cancer drugs.

I am between 18 and 79 years old.

+17 more

Exclusion Criteria

Conditions which would increase risk of lactic acidosis including:

I am currently taking medication for diabetes.

I have diabetes with high blood sugar or HgbA1C levels.

+10 more

Participant Groups

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.

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.

Metformin is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Glucophage for: