Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of participations (8 of 25)
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression-free survival
Secondary outcomes (4)
- measure
- Toxicity and feasibility
- measure
- Efficacy
- measure
- Comparison of duration of remission after first- vs second-line chemotherapy
- measure
- Rate of objective remission
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available