Safety and Efficacy of RAD001 in Participants With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® Therapy

Completed · Phase 2

Conditions studied: Lymphoma, Mantle- Cell

In brief

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®.

Key facts

Study ID

NCT00702052

Run by

Novartis Pharmaceuticals

People needed

58

Starts

2008-08-22

Expected to finish

2012-04-20

Last updated by the study team

2021-05-25

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult participants (≥18 years old) with Mantle Cell Lymphoma that has been confirmed by central pathology review (archival diagnostic tumor specimen required).
• Participants with mantle cell lymphoma who have documented refractory disease to Velcade® (bortezomib) or who have documented intolerance to Velcade® therapy. Intolerance to Velcade® is determined by the study investigator based on clinical evaluations. Participants 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®. Participants are considered refractory to Velcade®, if Velcade® is part of a combination treatment for the disease.
• Participants must have received at least one prior antineoplastic agent, other than Velcade® either separately or in combination with Velcade® (bortezomib).
• 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 computer tomography (CT) scan (or magnetic resonance imaging (MRI), only if CT scan can not be performed).
• Eastern Cooperative Oncology Group (ECOG) performance status = 0, 1 or 2.
• Life expectancy ≥3 months.
• Adequate bone marrow, liver and renal function.
• Platelets ≥75 x 10\^9/L (untransfused platelets).

You may not qualify if…

• Participants 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 mammalian target of rapamycin (mTOR) inhibitors (e.g. everolimus, sirolimus, temsirolimus, etc).
• Participants 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.
• Participants with central nervous system (CNS) lymphoma are not eligible; head magnetic resonance imaging (MRI) (or computer tomography (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 participants are not eligible; (human immunodeficiency virus (HIV) testing is not required for study entry; review of previous medical records is required).
• Uncontrolled hyperlipidemia (≥Grade 3 hyperlipidemia despite optimal supportive medical therapy).
• 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 (New York Heart Association 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.

Where it is running

• 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
• 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
• St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2) — Beech Grove, Indiana, United States
• Central Indiana Cancer Centers CICC - East (2) — Indianapolis, Indiana, United States
• University of Michigan Comprehensive Cancer Center Dept of Michigan Cancer Center — Ann Arbor, Michigan, United States
• Mayo Clinic - Rochester Hematology — Rochester, Minnesota, United States
• Washington University School Of Medicine-Siteman Cancer Ctr Medical Oncology — St Louis, Missouri, United States
• Hackensack University Medical Center Dept ofHackensackUniversityMC — Hackensack, New Jersey, United States
• New York University Medical Center NYU Cancer Institute — New York, New York, United States
• East Carolina University BrodySchool of Medicine — Greenville, North Carolina, United States
• Northwest Cancer Specialists Vancouver Cancer Center (2) — Portland, Oregon, United States
• Kaiser Permanente Northwest Dept of Kaiser Northwest (3) — Portland, Oregon, United States
• Fox Chase Cancer Center Regulatory Contact — Philadelphia, Pennsylvania, United States
• Western Pennsylvania Cancer Institute /Western Penn Hospital Western Pann. Cancer Inst. — Pittsburgh, Pennsylvania, United States
• University of Pittsburgh Medical Center Hillman Cancer Center (4) — Pittsburgh, Pennsylvania, United States
• Cancer Centers of the Carolinas CC of C -Eastside — Greenville, South Carolina, United States
• Vanderbilt University Medical Center, Clinical Trials Center Dept. of VUMC — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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