IELSG 34: A Multicenter Phase II study to evaluate the clinical activity and the safety profile of everolimus (RAD001) in marginal zone B-cell lymphomas (MZL) EudraCT Number 2009-011725-14 - IELSG 34

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-011725-14-IT

Enrollment

Registered

2010-03-19

Start date

2010-06-23

Completion date

Unknown

Last updated

2021-12-21

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

Conditions

Relapsed or refractory marginal zone B-cell lymphomas. MedDRA version: 9.1 Level: LLT Classification code 10029463 MedDRA version: 9.1 Level: LLT Classification code 10041652 MedDRA version: 9.1 Level: LLT Classification code 10015823 MedDRA version: 9.1 Level: LLT Classification code 10015824

Interventions

Pharmaceutical Form: Tablet INN or Proposed INN: Everolimus Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age > 18 years. Histologically proven diagnosis of marginal zone B-cell lymphoma relapsing/refractory following at least 1 prior systemic treatment (chemotherapy and or monoclonal antibodies). Any stage (Ann Arbor I-IV). Measurable or evaluable disease. ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Serious underlying medical condition which could impair the ability of the patient to participate in the trial. Presence or history of CNS lymphoma localization (either parenchymal or lmeningeal disease). Patients with concomitant or past hematological malignancies, except cervical type 1 intraepithelial neoplasia or localized non-melanomatous skin cancer. Evidence of active opportunistic infections, no HIV infection, no active HBV and or HCV infection. Prior chemo-or radiotherapy in the last 6 weeks, no prior immunotherapy in the last 8 weeks, no corticosteroids during the last 4 weeks unless low-dose prednisone chronically administered for indications other than lymphoma or lymphoma-related symptoms. Previous organ transplantation. Pregnant lactating status.

Design outcomes

Primary

Measure	Time frame
Main Objective: To define the antitumor activity, in terms of overall response rate (ORR), as sum of complete remissions (CR) and partial remissions (PR) of everolimus (RAD001) in relapsed or refractory marginal zone B-cell lymphomas.;Secondary Objective: Safety, as acute or long-term toxicity. Response duration (RD) (time to relapse or progression) in responders. Progression-free survival (PFS) (time to disease progression or death from any cause) in all patients.;Primary end point(s): Overall response rate (ORR), as sum of complete remissions (CR) and partial remissions (PR). Safety, as acute or long-term toxicity.	—

Measure

Time frame

Main Objective: To define the antitumor activity, in terms of overall response rate (ORR), as sum of complete remissions (CR) and partial remissions (PR) of everolimus (RAD001) in relapsed or refractory marginal zone B-cell lymphomas.;Secondary Objective: Safety, as acute or long-term toxicity. Response duration (RD) (time to relapse or progression) in responders. Progression-free survival (PFS) (time to disease progression or death from any cause) in all patients.;Primary end point(s): Overall response rate (ORR), as sum of complete remissions (CR) and partial remissions (PR). Safety, as acute or long-term toxicity.

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Countries

Austria, Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026