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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT00702052

Public ClinicalTrials.gov record NCT00702052. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 4, 2026, 2:19 PM EST

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Official title

An Open-Label, Single-Arm, Phase II Study of RAD001 in Patients With Mantle Cell Lymphoma Who Are Refractory or Intolerant to Velcade® (Bortezomib)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00702052
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
58 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 90 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 22, 2008 (Actual)
Primary completion
Apr 20, 2012 (Actual)
Completion
Apr 20, 2012 (Actual)
Last update posted
May 25, 2021

2008 – 2012

United States locations

U.S. sites
31
U.S. states
21
U.S. cities
28
Facility City State ZIP Site status
Mayo Clinic - Arizona Mayo Clinic - Scottsdale Multiple Locations Arizona 85259 —
Highlands Oncology Group DeptofHighlandsOncologyGrp(2) Fayetteville Arkansas 72703 —
Bay Area Cancer Research Dept.ofBayAreaCancerResearch Concord California 94520 —
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1) Duarte California 91010-3000 —
UCLA/ University of California Los Angeles Dept.of Hem/Oncology Los Angeles California 90095 —
University of California Davis Cancer Center Dept. of UC Davis Cancer (4) Sacramento California 95817 —
Rocky Mountain Cancer Centers RMCC - Denver-Midtown Greenwood Village Colorado 80121 —
Advanced Medical Specialties Medical Onc Hem Miami Florida 33176 —
Georgia Health Sciences University Dept. of MCG Augusta Georgia 30912 —
Northwestern University Chicago Illinois 60611 —
St. Francis Cancer Research Foundation Dept.ofSt.FrancisCancerRes.(2) Beech Grove Indiana 46107 —
Central Indiana Cancer Centers CICC - East (2) Indianapolis Indiana 46227 —
University of Michigan Comprehensive Cancer Center Dept of Michigan Cancer Center Ann Arbor Michigan 48109-0944 —
Mayo Clinic - Rochester Hematology Rochester Minnesota 55905 —
Washington University School Of Medicine-Siteman Cancer Ctr Medical Oncology St Louis Missouri 63110 —
Hackensack University Medical Center Dept ofHackensackUniversityMC Hackensack New Jersey 07601 —
New York University Medical Center NYU Cancer Institute New York New York 10016 —
East Carolina University BrodySchool of Medicine Greenville North Carolina 27858 —
Northwest Cancer Specialists Vancouver Cancer Center (2) Portland Oregon 97210 —
Kaiser Permanente Northwest Dept of Kaiser Northwest (3) Portland Oregon 97227 —
Fox Chase Cancer Center Regulatory Contact Philadelphia Pennsylvania 19111-2497 —
Western Pennsylvania Cancer Institute /Western Penn Hospital Western Pann. Cancer Inst. Pittsburgh Pennsylvania 15224 —
University of Pittsburgh Medical Center Hillman Cancer Center (4) Pittsburgh Pennsylvania 15232 —
Cancer Centers of the Carolinas CC of C -Eastside Greenville South Carolina 29605 —
Vanderbilt University Medical Center, Clinical Trials Center Dept. of VUMC Nashville Tennessee 37212 —
Baylor College of Medicine Dept. of Sammons Cancer (2) Dallas Texas 75246 —
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(2) Dallas Texas 75390-8527 —
MD Anderson Cancer Center/University of Texas Dept. of MD Anderson (10) Houston Texas 77030-4009 —
Tyler Cancer Center Dept.ofTylerCancerCtr. Tyler Texas 75702 —
Cancer Care Northwest CC Northwest- Spokane South(3) Spokane Washington 99202 —
West Virginia University/ Mary Babb Randolph Cancer Center Morgantown West Virginia 26506 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00702052, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 25, 2021 · Synced Nov 4, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00702052 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →