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


Phase 2
18 Years
90 Years
Not Enrolling
Both
Lymphoma, Mantle- Cell

Thank you

Trial Information

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


Inclusion Criteria:



- 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)

Exclusion Criteria:

- 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)

- 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 (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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

at the end of the study

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001N2201

NCT ID:

NCT00702052

Start Date:

August 2008

Completion Date:

April 2012

Related Keywords:

  • Lymphoma, Mantle- Cell
  • Mantle Cell Lymphoma
  • Lymphoma
  • B-Cell Lymphoma
  • Mantle Zone Lymphoma
  • Refractory Lymphoma
  • Aggressive Lymphoma
  • PILLAR-1
  • Lymphoma
  • Lymphoma, Mantle-Cell

Name

Location

Northwestern UniversityChicago, Illinois  60611
Cancer Centers of the Carolinas CC of C -EastsideGreenville, South Carolina  29605
Mayo Clinic - Arizona Mayo Clinic - Scottsdale*see Various Departments*, Arizona  
Highlands Oncology Group DeptofHighlandsOncologyGrp(2)Fayetteville, Arkansas  72703
Bay Area Cancer Research Dept.ofBayAreaCancerResearchConcord, California  94520
City of Hope National Medical Center Dept.ofCityofHopeMedicalCtr(1)Duarte, California  91010-3000
UCLA/ University of California Los Angeles Dept.of Hem/OncologyLos Angeles, California  90095
University of California Davis Cancer Center Dept. of UC Davis Cancer (4)Sacramento, California  95817
Rocky Mountain Cancer Centers RMCC - Denver-MidtownGreenwood Village, Colorado  
Advanced Medical Specialties Medical Onc HemMiami, Florida  33176
Georgia Health Sciences University Dept. of MCGAugusta, Georgia  30912
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 CenterAnn Arbor, Michigan  48109-0944
Mayo Clinic - Rochester HematologyRochester, Minnesota  55905
Washington University School Of Medicine-Siteman Cancer Ctr Medical OncologySt. Louis, Missouri  63110
Hackensack University Medical Center Dept ofHackensackUniversityMCHackensack, New Jersey  07601
New York University Medical Center NYU Cancer InstituteNew York, New York  10016
East Carolina University BrodySchool of MedicineGreenville, 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 ContactPhiladelphia, Pennsylvania  19111-2497
University of Pittsburgh Medical Center Hillman Cancer Center (4)Pittsburgh, Pennsylvania  
Western Pennsylvania Cancer Institute /Western Penn Hospital Western Pann. Cancer Inst.Pittsburgh, Pennsylvania  15224
Vanderbilt University Medical Center, Clinical Trials Center Dept. of VUMCNashville, Tennessee  37212
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 CenterMorgantown, West Virginia  26506
Baylor College of Medicine Dept. of Sammons Cancer (2)Dallas, Texas  75246