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TerminatedNCT00727207Updated Dec 17, 2012

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

A Phase 2 interventional study of everolimus in Lymphoma, sponsored by Technical University of Munich. Terminated at 1 site in Germany. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2012-12-17.

Sponsored by Technical University of Munich · Phase 2, Interventional, and Treatment

Why this study was terminated
Lack of participations (8 of 25)
Phase
Phase 2
Study type
Interventional
Enrollment
35
Allocation
Non-randomized
Ages
40 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

OBJECTIVES:

Primary

  • 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.

Secondary

  • 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.

02

Conditions studied

  • Lymphoma

Keywords

  • recurrent mantle cell lymphoma
  • contiguous stage II mantle cell lymphoma
  • noncontiguous stage II mantle cell lymphoma
  • stage I mantle cell lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 35 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Enrollment
35 participants (estimated)

Interventions

  • Drugeverolimus
06

What researchers measure

Primary outcomes

  1. Progression-free survival

Secondary outcomes

  1. Toxicity and feasibility

  2. Efficacy

  3. Comparison of duration of remission after first- vs second-line chemotherapy

  4. Rate of objective remission

07

Study locations

1 site
  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen
    Munich, D-81675, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00727207
Lead sponsor
Technical University of Munich
Responsible party
Sponsor
First posted
Aug 1, 2008
Start date
May 2008
Primary completion
May 2011
Completion
Sep 2014 (estimated)
Last update
Dec 17, 2012

Study contacts

Ulrich Keller, MD
principal investigator · Technical University of Munich
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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