Everolimus in Treating Older Patients With Mantle Cell Lymphoma Previously Treated With First-Line or Second-Line Chemotherapy
NCT ID: NCT00727207
Last Updated: 2012-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
35 participants
INTERVENTIONAL
2008-05-31
2014-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
TREATMENT
Interventions
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everolimus
Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
ALL
No
Sponsors
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Technical University of Munich
OTHER
Responsible Party
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Principal Investigators
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Ulrich Keller, MD
Role: PRINCIPAL_INVESTIGATOR
Technical University of Munich
Locations
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Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, , Germany
Countries
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Other Identifiers
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KRDI-TUM-CRAD001C2428
Identifier Type: -
Identifier Source: secondary_id
EUDRACT: 2007-005116-12
Identifier Type: -
Identifier Source: secondary_id
EU-20855
Identifier Type: -
Identifier Source: secondary_id
CDR0000597004
Identifier Type: -
Identifier Source: org_study_id