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A Phase II Pilot Study of Metformin Therapy in Patients With Relapsed Chronic Lymphocytic Leukemia and Untreated CLL Patients With Genomic Deletion 11q

Phase 2
18 Years
80 Years
Open (Enrolling)
Relapsed Chronic Lymphocytic Leukemia

Thank you

Trial Information

A Phase II Pilot Study of Metformin Therapy in Patients With Relapsed Chronic Lymphocytic Leukemia and Untreated CLL Patients With Genomic Deletion 11q

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 (see Appendix A)

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
bilirubin < ULN (exception of Gilbert disease) serum creatinine less than or equal to
1.5 in males, or 1.4 in female GFR > 60

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

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 17 History of metabolic acidosis
Ongoing or active infection concerning for sepsis or SIRS

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to treatment failure

Outcome Description:

Time to treatment failure: While patients are on metformin therapy, time to treatment failure will be defined as one or all of the following criteria: ALC > 5000 on 3 occasions after start of metformin treatment and increasing by 25% or more on each occasion, which will be measured every 3 months. An increase of Rai Stage by one stage. An increase in any lymph node by >50% as assessed by either physical exam (all patients) or CT scanning (only if ordered as part of routine clinical management). Worsening cytopenias (Hemoglobin <11 g/dl or platelet count <100,000)

Outcome Time Frame:

every 3 months

Safety Issue:


Principal Investigator

sami Malek, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Food and Drug Administration

Study ID:

UMCC 2012.025



Start Date:

October 2012

Completion Date:

October 2016

Related Keywords:

  • Relapsed Chronic Lymphocytic Leukemia
  • Relapsed Chronic Lymphocytic Leukemia
  • untreated CLL patients
  • genomic deletion 11q
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752