Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy

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. Identifier: NCT00727207
Recruitment Status : Terminated (Lack of participations (8 of 25))
First Posted : August 1, 2008
Last Update Posted : December 17, 2012
Information provided by (Responsible Party):
Technische Universität München

July 31, 2008
August 1, 2008
December 17, 2012
May 2008
May 2011   (Final data collection date for primary outcome measure)
Progression-free survival
Same as current
Complete list of historical versions of study NCT00727207 on Archive Site
  • Toxicity and feasibility
  • Efficacy
  • Comparison of duration of remission after first- vs second-line chemotherapy
  • Rate of objective remission
Same as current
Not Provided
Not Provided
Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
Phase II Trial on Efficacy of mTOR Inhibitor RAD001 as Maintenance Therapy for Patients Above 60 Years in Mantle Cell Lymphoma After First and Second Line Chemotherapy

RATIONALE: Everolimus may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

PURPOSE: This phase II trial is studying how well everolimus works in treating older patients with mantle cell lymphoma who received previous first-line or second-line chemotherapy.



  • Determine the progression-free survival of older patients with mantle cell lymphoma receiving everolimus and who were previously treated with first- or second-line chemotherapy.


  • Determine the toxicity and feasibility of treatment with this drug.
  • Determine the efficacy of this drug in these patients.
  • Compare the duration of remission after first- vs second-line chemotherapy.
  • Determine the rate of objective remission.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 3 years.

Phase 2
Allocation: Non-Randomized
Primary Purpose: Treatment
Drug: everolimus
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2014
May 2011   (Final data collection date for primary outcome measure)


  • Diagnosis of mantle cell lymphoma
  • Stable disease after first- or second-line chemotherapy
  • No uncontrolled cerebral or leptomeningeal disease


  • WHO performance status 0-2
  • Life expectancy ≥ 3 months
  • Age ≥ 60 years or patients ≥ 40 and < 60 years who are not suitable for high-dose chemotherapy followed by autologous stem cell transplantation or allogeneic stem cell transplantation
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin > 9 g/dL
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • SGPT and SGOT ≤ 3 times ULN
  • Bilirubin ≤ 1.5 times ULN
  • No other malignancies within the past 3 years except treated cervical carcinoma or basal cell cancer
  • No other serious or non-controlled illnesses (e.g., diabetes mellitus, uncontrolled hypertension, serious infections, serious malnutrition, unstable angina pectoris, weak heart, myocardial infarction within the past 6 months, chronic liver illness, active ulceration in the gastrointestinal tract, psychiatric illness)
  • No known HIV infection
  • No gastrointestinal disturbances that could influence the absorption of everolimus and cause short-intestine syndrome (e.g., atrophic gastritis)
  • No coagulation or bleeding diatheses
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Patients must have complied with their previous drug prescription


  • See Disease Characteristics
  • See Patient Characteristics
  • Recovered from all prior therapy
  • At least 2 weeks since prior surgery, radiotherapy, or systemic antitumor therapy
  • More than 4 weeks since prior experimental medication
  • No chronic therapy with systemic steroids or other immunosuppressants except rituximab
  • No prior organ transplantation
  • No therapy with vitamin K antagonist, except low-dose coumarin
  • No prior mTOR inhibitors
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
EUDRACT: 2007-005116-12
Not Provided
Not Provided
Not Provided
Technische Universität München
Technische Universität München
Not Provided
Principal Investigator: Ulrich Keller, MD Technische Universität München
Technische Universität München
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP