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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

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00727207
Enrollment
35
Registered
2008-08-01
Start date
2008-05-31
Completion date
2014-09-30
Last updated
2012-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

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.

Interventions

DRUGeverolimus

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Progression-free survival

Secondary

MeasureTime frame
Comparison of duration of remission after first- vs second-line chemotherapy
Rate of objective remission
Toxicity and feasibility
Efficacy

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026