A phase II trial to evaluate the safety and activity of single-agent lenalidomide given as maintenance therapy after response to second-line therapy in patients with relapsed diffuse large B cell lymphoma, not eligible for high-dose chemotherapy and autologous transplantation [Lenalidomide and DLBCL - ND

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003729-18-IT

Enrollment

Registered

2008-06-13

Start date

2008-09-25

Completion date

Unknown

Last updated

2024-03-12

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

Conditions

patients affected by diffused linfoma with big cells MedDRA version: 9.1 Level: LLT Classification code 10012818 Term: Diffuse large B-cell lymphoma

Interventions

Trade Name: REVLIMID Pharmaceutical Form: Capsule, hard INN or Proposed INN: LENALIDOMIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age  65 years or younger but not eligible to high-dose chemotherapy and autologous stem cell transplantation - biopsy-proven DLBCL relapsed to previous combination chemotherapy regimen ± rituximab - PR or CR to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab - ECOG performance status score  3 - Female of childbearing potential (FCBP) must demonstrate to practice a proper contraception to avoid any pregnancy risk during the study and at least 28 days after the discontinuation of the study - Male subjects must agree to practice a proper contraception during any sexual contact with females childbearing potential Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - CNS involvement - Prior ASCT - TTP 2 x upper normal limit; ALT/AST/GGT > 3 x upper normal limit) at one month from salvage chemotherapy conclusion - Impaired renal function (creatinine clearance <50 ml/min) at one month from salvage chemotherapy conclusion - Absolute neutrophil count (ANC) <1000/L - Platelet count <75.000 /mm3 - Hemoglobin <9 g/dL - Non-co-operative behaviour or non-compliance - Psychiatric diseases or conditions that might impair the ability to give informed consent - Pregnant or lactating females

Design outcomes

Primary

Measure	Time frame
Main Objective: To explore the efficacy of lenalidomide monotherapy given as maintenance therapy following salvage chemotherapy in patients with relapsed or refractory DLBCL;Secondary Objective: To evaluate the safety of Lenalidomide maintenance therapy in this setting;Primary end point(s): One-year progression free survival	—

Countries

Italy

Outcome results

None listed

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