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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
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,

- 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:


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:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




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



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