Safety and Efficacy of RAD001 in Patients With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® Therapy. (PILLAR-1)
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.
Read our disclaimer for details.
This study is to evaluate the safety and efficacy of a daily, oral dose of 10 mg RAD001 in patients with Mantle Cell Lymphoma who are refractory or intolerant to Velcade® therapy and who have received at least one prior antineoplastic agent other than Velcade®, either separately or in combination with Velcade® (see inclusion criteria). Intolerance to Velcade® therapy is determined by the study investigator based on clinical evaluations. Patients are 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®.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adult patients (> 18 years old) with Mantle Cell Lymphoma that has been confirmed by central pathology review (archival diagnostic tumor specimen required)
Patients with mantle cell lymphoma who have documented refractory disease to bortezomib (Velcade®) or who have documented intolerance to Velcade® therapy. Intolerance to Velcade® is determined by the study investigator based on clinical evaluations. Patients are considered refractory to Velcade® if they have documented radiological progression on or within 12 months of last dose of Velcade® when given alone or, on or within 12 months from the last dose of the last component of a combination therapy which included Velcade®). Patients are considered refractory to Velcade®, if Velcade® is part of a combination treatment for the disease.
Patients must have received at least one prior antineoplastic agent, other than Velcade® either separately or in combination with bortezomib (Velcade®).
At least one site of measurable nodal disease at baseline >2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan (or MRI, only if CT scan can not be performed)
ECOG performance status = 0, 1 or 2
Life expectancy ≥ 3 months
Adequate bone marrow, liver and renal function
Platelets ≥ 75 x 109/L (untransfused platelets)
Patients who are currently receiving anticancer therapies or have received anticancer therapies within 4 weeks of the start of study drug (including chemotherapy, radiation, antibodies, targeted therapy etc.) are not eligible
Previous treatment with mTOR inhibitors (e.g. everolimus, sirolimus, temsirolimus, etc)
Patients with prior allogeneic stem cell transplant
Grade 3 or 4 unresolved toxicity from prior antineoplastic therapies
Currently taking other investigational agents or received other investigational drugs within 4 weeks of the start of study drug
Patients with CNS lymphoma are not eligible; head MRI (or CT if MRI is not available) is required prior to study entry
Use of chronic, systemic corticosteroids or another immunosuppressive agent, except prednisone ≤ 20 mg daily (or equivalent) for adrenal insufficiency (must have been on a stable dosage regimen for ≥ 4 weeks prior to the first treatment with RAD001)
HIV positive patients are not eligible; (HIV testing is not required for study entry; review of previous medical records is required)
Active, bleeding disorders or major surgery within 4 weeks of starting study drug
Severe and/or uncontrolled medical conditions such as symptomatic congestive heart failure (NYHA Class III or IV), unstable angina, myocardial infarction within 6 months or study start, severely impaired lung function, cirrhosis, chronic active/persistent hepatitis.
History of another primary malignancy ≤ 3 years prior to study entry