Clinical trial · Interventional
Everolimus in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma
Master Protocol for Mantle Cell Lymphoma A Multicenter Phase II Trial Testing Everolimus (RAD001) for the Treatment of Patients With Relapsed or Therapy Resistant Mantle Cell Lymphoma
NCT00516412CI-TRIAL-00019242completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
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 patients with relapsed or refractory mantle cell lymphoma.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| everolimus | Drug | Everolimus | ALIAS |
| molecular response by PCR | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Everolimus
- description
- Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: everolimus
- Genetic: molecular response by PCR
Primary outcomes (1)
- measure
- Evaluation of the efficacy and tolerability of everolimus
- timeFrame
- Until treatment ends
Secondary outcomes (3)
- measure
- Evaluation of the efficacy of everolimus to induce molecular remission in patients treated with this regimen.
- timeFrame
- Until treament ends
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Inclusion criteria: * Histologically or cytologically confirmed relapsed or chemotherapy/immunotherapy-resistant mantle cell lymphoma * No more than 3 lines of prior systemic treatment * At least one measurable lesion ≥ 15 mm in its greatest transverse diameter by CT scan Exclusion criteria: * Presence or history of CNS disease (either CNS lymphoma or lymphomatous meningosis) * Newly diagnosed mantle cell lymphoma * Patients suitable for intensive treatment (e.g., hyperfractionated cyclophosphamide, vincristine, doxorubicin hydrochloride and dexamethasone with high-dose methotrexate and cytarabine \[HyperCVAD\]) PATIENT CHARACTERISTICS: Inclusion criteria: * WHO performance status ≤ 2 * Creatinine clearance ≥ 30mL/min * Bilirubin ≤ 2 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2 times ULN * AST and ALT ≤ 2 times ULN * Neutrophils ≥ 1,500/mm³ (≥ 1,000/mm³ with marrow infiltration) * Thrombocytes ≥ 100,000/mm³ (≥ 75,000/mm³ in case of bone marrow infiltration) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 months after study participation Exclusion criteria: * Prior or concurrent hematological malignancies * Patients with prior solid organ tumors that required no treatment over the last 5 years and are currently free of disease are eligible * Cardiovascular disease including any of the following: * NYHA class III or IV congestive heart failure * Unstable angina pectoris * Significant arrhythmia or arrhythmia requiring chronic treatment * Myocardial infarction in the last 3 months * Serious underlying medical condition which could impair the ability of the patient to participate in the trial including any of the following: * Uncontrolled diabetes mellitus * Gastric ulcers * Active autoimmune disease * Ongoing infection (e.g., HIV or hepatitis) PRIOR CONCURRENT THERAPY: Exclusion criteria: * Prior radiation where the indicator lesion(s) are in the irradiated field * Prior organ transplantation * Participation in another clinical trial within 30 days prior to study entry * Concurrent anticancer drugs/treatments or experimental medications * Other concurrent investigational therapy * Other concurrent chemotherapy, immunotherapy, or radiotherapy (including palliative radiotherapy)
References
Publications (1)
- RESULTRenner C, Zinzani PL, Gressin R, Klingbiel D, Dietrich PY, Hitz F, Bargetzi M, Mingrone W, Martinelli G, Trojan A, Bouabdallah K, Lohri A, Gyan E, Biaggi C, Cogliatti S, Bertoni F, Ghielmini M, Brauchli P, Ketterer N; Swiss SAKK and French GOELAMS group from European Mantle Cell Lymphoma Network. A multicenter phase II trial (SAKK 36/06) of single-agent everolimus (RAD001) in patients with relapsed or refractory mantle cell lymphoma. Haematologica. 2012 Jul;97(7):1085-91. doi: 10.3324/haematol.2011.053173. Epub 2012 Feb 7. PMID 22315486