Diabetes drug metformin tested as possible CLL treatment
NCT ID NCT01750567
First seen Jun 25, 2026 · Last updated Jul 21, 2026 · Updated 3 times
Summary
This phase 2 pilot study tested the diabetes drug metformin in 37 people with chronic lymphocytic leukemia (CLL) that had come back after treatment, or in untreated CLL with a specific genetic change (11q deletion). The goal was to see if metformin could slow the cancer's growth. Metformin is cheap and generally safe, but this was a small, early study, so results are not conclusive.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Metformin (Glucophage), a diabetes drug
- What this could lead to
- If it works, this could point toward a new, inexpensive, and well-tolerated treatment option for certain types of chronic lymphocytic leukemia.
- What could go wrong
- This is a small, early-phase pilot study with only 37 participants. Metformin is not a standard cancer treatment, and it may not slow the disease or may cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
37 people
The number who actually took part.
- Started
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Nov 2012
- Finished
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Feb 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients should have a confirmed diagnosis of chronic lymphocytic leukemia defined as all of the following: * ALC \> 5000 * Positive for either CD19 or CD 20 together with CD23 and CD5. * Less than 55% atypical cells 2. Patients who relapse after receiving a one or more courses of fludarabine, bendamustine, cytoxan, rituxan, chlorambucil, or campath based therapy. 3. Patients should have findings of relapse by one or both of the following: * ALC \> 5000 on 2 consecutive occasions and increasing * Any increase in lymphadenopathy over best response that has persisted for more than 3 months 4. Patient with confirmed del11q mutation may be included if untreated. 5. Age \> or equal to 18 years old and \< 80 years of age during the course of therapy 6. ECOG performance 0-2 7. Life expectancy \> 12 months 8. Patients must have normal organ function as defined as below: * AST and ALT \< 2 times the upper limit of normal * alkaline phosphatase \< 2 ULN * serum conjugated bilirubin \< 1.5 ULN (exception of Gilbert disease) * serum creatinine less than or equal to 1.5 in males, or 1.4 in females * GFR \> 59 9. Ability to understand and the willingness to sign a written informed consent document 10. Patient must be able to drink and eat more than 75% of their usual daily meals. Exclusion Criteria: 1. Patients with active CLL disease requiring urgent chemotherapy 2. Patients may not be receiving any other investigational agents. 3. Patients less than 30 days from last treatment for CLL. 4. History of allergic reactions attributed to metformin or other biguanides. 5. Known diabetes (type 1 or 2), fasting glucose \> or equal to 7.0 mmol/L (126 mg/dL), or HgbA1C \> 6.5 6. Currently taking metformin, sulfonylureas, thiazolidinediones or insulin for any reason 7. Current or planned pregnancy or lactation in women of child bearing age (confirmed by negative pregnancy test prior to start of therapy). 8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection and sepsis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements 9. Conditions which would increase risk of lactic acidosis including: * Known alcoholism or ingestion of more than 3 alcoholic beverages per day * History of congestive heart failure defined as NYHA class III or IV * History of metabolic acidosis * Ongoing or active infection concerning for sepsis or SIRS
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109, United States
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