A Pilot Study of Metformin Therapy in Patients With Relapsed Chronic Lymphocytic Leukemia (CLL) and Untreated CLL
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|ClinicalTrials.gov Identifier: NCT01750567|
Recruitment Status : Recruiting
First Posted : December 17, 2012
Last Update Posted : May 12, 2022
|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|
|Actual Study Start Date :||November 2012|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2023|
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: Until the patient meets failure criteria and stops Metformin; up to 6 months after start of metformin therapy and yearly thereafter. ]
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 (0-3) 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) associated with a bone marrow biopsy result indicating advanced stage CLL (packed CLL marrow).
- 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: Until the patient meets failure criteria and stops Metformin ]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.
- Change in size of clinically appreciated lymphadenopathy in cm and splenomegaly while on metformin therapy [ Time Frame: Baseline up to 3 months after completing metformin therapy ]The proportion of patients that begin metformin therapy with these conditions will be summarized, along with the proportions at study defined clinical assessment points during therapy. No statistical models will be employed, but proportions and 95% exact binomial confidence intervals will be reported for descriptive purposes.
- Change in number of clinically appreciated lymphadenopathy and splenomegaly while on metformin therapy [ Time Frame: Baseline up to 3 months after completing metformin therapy ]The proportion of patients that begin metformin therapy with these conditions will be summarized, along with the proportions at study defined clinical assessment points during therapy. No statistical models will be employed, but proportions and 95% exact binomial confidence intervals will be reported for descriptive purposes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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 email@example.com|
|Contact: Erlene Seymour, MD 734-647-2892 firstname.lastname@example.org|
|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|