A Pilot Study of Metformin Therapy in Patients With Relapsed Chronic Lymphocytic Leukemia (CLL) and Untreated CLL
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01750567|
Recruitment Status : Recruiting
First Posted : December 17, 2012
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Chronic Lymphocytic Leukemia||Drug: Metformin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Pilot Study of Metformin Therapy in Patients With Relapsed Chronic Lymphocytic Leukemia and Untreated CLL Patients With Genomic Deletion 11q|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
Experimental: Metformin (Glucophage)
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 an antidiabetic drug which is an inexpensive and generally well tolerated medication.
Other Name: Glucophage
- Time to treatment failure [ Time Frame: every 3 months ]
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)
- Time to first therapy (TTFT) in previously untreated 11q CLL subsets only. [ Time Frame: from time of diagnosis to time of first treatment with anti‐neoplastic chemotherapy. ]to evaluate TTFT in untreated patients, the product‐limit method of Kaplan and Meier will be used similarly to the primary endpoint. The main difference between this endpoint and the primary endpoint is that TTFT will be defined from the date of CLL diagnosis for untreated delq11 patients
- changes in the rate of increase of absolute lymphocyte count while on metformin therapy [ Time Frame: 6 months ]longitudinal lymphocyte counts will be modeled using mixed models methodology, whereby both fixed effects (dose of metformin) and random effects (intercept - starting lymphocyte count) can be modeled.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01750567
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center||Recruiting|
|Ann Arbor, Michigan, United States, 48109|
|Contact: Sami Malek, MD 734-936-5310 firstname.lastname@example.org|
|Contact: Erlene Seymour, MD 734-647-2892 email@example.com|
|Principal Investigator: Sami Malek, MD|
|Sub-Investigator: Daniel Lebovic, MD|
|Sub-Investigator: Erlene Seymour, MD|
|Principal Investigator:||Sami Malek, MD||University of Michigan Rogel Cancer Center|