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.
Same as current
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, Older Adult)
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