This study was to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in participants with Mantle Cell Lymphoma who were refractory or intolerant to Velcade® therapy and who had received at least one prior antineoplastic agent other than Velcade®, either separately or in combination with Velcade® (see inclusion criteria). Intolerance to Velcade® therapy was determined by the study investigator based on clinical evaluations. Participants were considered refractory to Velcade® if they have documented radiological progression on or within 12 months of the last dose of Velcade® when given alone or, on or within 12 months of the last dose of the last component of a combination therapy which included Velcade®.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Everolimus tablets
Mayo Clinic - Arizona Mayo Clinic - Scottsdale
Multiple Locations, Arizona, United States
Highlands Oncology Group DeptofHighlandsOncologyGrp(2)
Fayetteville, Arkansas, United States
Bay Area Cancer Research Dept.ofBayAreaCancerResearch
Concord, California, United States
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)
Duarte, California, United States
UCLA/ University of California Los Angeles Dept.of Hem/Oncology
Los Angeles, California, United States
Overall Response Rate (ORR)
Overall response rate was defined as the percentage of participants with a best overall disease response of complete response (CR) or partial response (PR). CR was defined as complete disappearance of all extranodal lesions. PR was defined as at least a 50% decrease in the sum of the product of diameter (SPD) of all index nodal and extranodal lesions.
Time frame: From date of enrollment up to disease progression or death (approximately 3.8 years)
Disease Control Rate (DCR)
Disease Control Rate was defined as the percentage of participants with best overall disease response of CR or PR or stable disease (SD). CR was defined as complete disappearance of all extranodal lesions. PR was defined as at least a 50% decrease in SPD of all index nodal and extranodal lesions. SD was defined failure to attain the criteria needed for CR or PR and failure to fulfill the criteria for at least a 50% increase in the SPD of all index nodal and extranodal (including splenic and/or hepatic nodules) lesions, taking as reference the smallest sum of the product of the diameters of all index lesions recorded at or after baseline.
Time frame: From date of start of treatment up to disease progression or death (approximately up to 3.8 years)
Duration of Response
Duration of response was defined as the time from the date of first documented disease response (CR or PR) to the date of first documented progression or death due to lymphoma. CR was defined as complete disappearance of all extranodal lesions. PR was defined as at least a 50% decrease in SPD of all index nodal and extranodal lesions.
Time frame: From date of start of treatment up to disease progression or death (approximately up to 3.8 years)
Progression Free Survival (PFS)
PFS was defined as the time from the date of start of treatment to the date of event defined as the first documented progression or death due to any cause.
Time frame: From date of start of treatment up to disease progression or death (approximately up to 3.8 years)
Overall Survival
Overall survival was defined as the time from the date of start of study treatment to the date of death due to any cause.
Time frame: From date of start of treatment up to disease progression or death (approximately up to 3.8 years)
Number of Participants With At Least One Adverse Event (AE) and Serious Adverse Event (SAE)
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A SAE was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.
Time frame: From the start of the study and 28 days after study drug discontinuation (approximately up to 18 months)
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University of California Davis Cancer Center Dept. of UC Davis Cancer (4)
Sacramento, California, United States
Rocky Mountain Cancer Centers RMCC - Denver-Midtown
Greenwood Village, Colorado, United States
Advanced Medical Specialties Medical Onc Hem
Miami, Florida, United States
Georgia Health Sciences University Dept. of MCG
Augusta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
...and 21 more locations