Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Mantle-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Mantle Cell Lymphoma

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Antirheumatic Agents

Cytarabine

Cyclophosphamide

Rituximab

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

lenalidomide 10-15 mg once daily on days 1-21, every 28 day, for two years

no therapy is planned but only observation

Treatment Phase: consisting in an induction phase (3 cycles of RCHOP, given every 21 days); consolidation phase: (high-dose cyclophosphamide (CTX), 2 cycles of high dose Ara-C, BEAM and ASCT).

Randomization and maintenance phase: Patients who have achieved complete or partial response will be randomized between maintenance with lenalidomide or observation.

Sergio Cortelazzo, MD

A phase III multicenter, randomized study with Lenalidomide (Revlimid®) maintenance versus observation after intensified induction regimen containing rituximab followed by high dose chemotherapy and Autologous Stem Cell Transplantation as first line treatment in adult patients with advanced Mantle Cell Lymphoma: IIL study (MCL0208).

This is a Phase 3, multicenter, open-label, randomized, controlled study to determine the efficacy and safety of lenalidomide as maintenance therapy versus observation in patients with MCL in complete or partial remission after first line intensified and high-dose chemotherapy additioned with rituximab and followed by ASCT. This study will be conducted in three phases: a Screening Phase, a Treatment Phase and a Follow-up Phase

Phase III, Randomized Trial: Lenalidomide vs Observation After Induction With Rituximab Followed by Cht and ASCT in MCL Adult Patients

A Phase III Multicenter, Randomized Study With Lenalidomide Maintenance vs Observation After Induction Regimen Containing Rituximab Followed by High Dose Chemotherapy and ASCT as First Line Treatment in Adult Patients With Advanced Mantle Cell Lymphoma

PFS will be defined as the time between the date of randomization and the date of disease progression, relapse or death from any cause.therapy to prolong progression-free survival (PFS) after completion of first-line high-dose chemotherapy additioned with rituximab and followed by ASCT in adult patients with MCL who have achieved complete response (CR) or partial response (PR). PFS is defined according to Cheson et al (JCO, 2007) as the time from randomisation until lymphoma progression or death as a result of any cause.

OS will be defined as the time between the date of randomization and the date of death from any cause

PFS will be defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause.

DFS will be defined in CR patients as the time between the date of randomization and the date of relapse or death as a result of lymphoma or acute toxicity of treatment according to the Cheson 2007

EFS will be defined in CR patients as the time between the date of randomization and the date of failure of treatment or death as a result of any cause according to the Cheson 2007

Proportion of CR according to the Cheson 2007 response criteria

ORR is defined as Complete Response (CR) or Partial Response (PR) according to the Cheson 2007 response criteria

Toxicity amount of grade 3 or more as CTCAE

Fondazione Italiana Linfomi - ETS

Anti-Inflammatory Agents

Antiemetics

Gastrointestinal Agents

Dexamethasone

Dexamethasone acetate

Lenalidomide will be supplied as 5 mg and 25 mg capsules for oral administration.Dexamethasone (Soldesam 0.2%) will be supplied as 20 mg liquid for oral administration (1 bottle = 20 mg; daily dose = 2 bottles = 40 mg).

Lenalidomide and Dexametasone

Francesco Zaja, MD

This is a prospective, multicenter phase II trial designed to evaluate the safety and activity of the combination of Lenalidomide (Len) and Dexamethasone (Dex) in patients with relapsed/refractory mantle cell lymphoma (MCL).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase III, Randomized Trial: Lenalidomide vs Observation After Induction With Rituximab Followed by Cht and ASCT in MCL Adult Patients	NCT02354313	MANTLE CELL LYM...	Lenalidomide	18 Years - 60 Years	Fondazione Italiana Linfomi - ETS
Salvage Treatment With Lenalidomide and Dexamethaosne (LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)	NCT00786851	MANTLE CELL LYM...	Lenalidomide an...	18 Years -	Fondazione Italiana Linfomi - ETS
Phase III, Randomized Trial: Lenalidomide vs Observation After Induction With Rituximab Followed by Cht and ASCT in MCL Adult Patients	NCT02354313	MANTLE CELL LYM...	Lenalidomide	18 Years - 60 Years	Fondazione Italiana Linfomi - ETS

Spots Global Cancer Trial Database for lenalidomide (len)