Clinical trial NCT00786851: Salvage Treatment With Lenalidomide and Dexamethaosne (LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
Official title: Salvage Treatment With Lenalidomide and Dexamethaosne(LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: MANTLE CELL LYMPHOMA
Keywords: MANTLE CELL LYMPHOMA (MCL)
Lenalidomide (Len)
Dexamethasone (Dex)
Lead sponsor: Fondazione Italiana Linfomi - ETS
Sponsor class: OTHER
Collaborators: name: Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
First posted: 2008-11-06
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of MCL
* Understand and voluntarily sign an informed consent form;
* Able to adhere to the study visit schedule and other protocol requirements;
* Age ≥ 18;
* Patients treated with at least one prior treatment regimen, not eligible for or relapsed after more intensive treatments (stem cell transplant);
* Patients with refractory or relapsed disease;
* Measurable and/or valuable disease;
* Adequate haematological counts: ANC \> 1.5 x 109/L and platelet count \> 75 x 109/L unless due to bone marrow involvement by MCL;
* Conjugated bilirubin up to 2 x ULN unless due to liver involvement by MCL;
* Alkaline phosphatase and transaminases up to 2 x ULN unless due to liver involvement by MCL;
* Creatinine clearance ≥ 50 ml/min;
* HIV negativity;
* HCV negativity;
* HBV negativity or patients with HBcAb +, HbsAg -, HBs Ab+/- and anti HBV prophylaxis with lamivudine;
* Non peripheral neuropathy or CNS disease;
* Life expectancy \> 6 months;
* Performance status \< 2 according to ECOG scale;Disease free of prior malignancies (a part MCL) with the exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast;
* Written informed consent;
* Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study drug; 2) while participating in the study; and 3) for at least 28 days after discontinuation from the study. The two methods of reliable contraception must include one highly effective method (i.e. intrauterine device (IUD), hormonal \[birth control pills, injections, or implants\], tubal ligation, partner's vasectomy) and one additional effective (barrier) method (i.e. latex condom, diaphragm, cervical cap). FCBP must be referred to a qualified provider of contraceptive methods if needed;

Exclusion Criteria:

* Patients who have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study;
* CNS disease (meningeal and/or brain involvement by lymphoma);
* TVP in the last year;
* History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances;
* Uncontrolled diabetes (if receiving antidiabetic agents, subjects must be on a stable dose for at least 3 months before first dose of study drug);
* Creatinine clearances \< 50 ml/min;
* HIV positivity;
* HBV positivity with the exception of patients with HBVcAb +, HbsAg -, HBs Ab+/- in anti HBV prophilaxis with lamivudine;
* Pregnant or lactating women;
* Hypersensitivity reactions to previous thalidomide (if any);
* Prior rash ≥ 3 while taking thalidomide (if any);
* Active opportunistic infection;
* Any other co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent;

Primary outcomes:
measure: To explore the antitumor activity of the association of Len-Dex in term of overall (OR) and complete response (CR) in patients with relapsed/refractory MCL
timeFrame: 3 years
Secondary outcomes:
measure: To explore the safety profile;
timeFrame: 2 years
measure: To explore the modification of tumoral neo-angiogenic biomarkers and the relationship with response to Len-Dex therapy;
timeFrame: 2 years
measure: To evaluate the clinical efficacy of Len-Dex in terms of response duration (RD) and overall survival (OS).
timeFrame: 2 years
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Ospedale SS. Antonio Biagio e Cesare Arrigo
city: Aviano (PN)
country: Italy
facility: Centro diriferimento oncologico
city: Brescia
country: Italy
facility: Ematologia Spedali Civili
city: Cagliari
country: Italy
facility: Ematologia Ospedale Businco
city: Milano
country: Italy
facility: Fondazione IRCCS UO Ematologia 1
city: Milano
country: Italy
facility: Ospedale Niguarda Cà granda
city: Milano
country: Italy
facility: Ospedale San Raffaele Ematologia
city: Pavia
country: Italy
facility: Università Policlinico San Matteo Divione di Ematologia
city: Reggio Calabria
country: Italy
facility: AO Bianchi Melacrino Morelli UO Ematologia
city: Reggio Emilia
country: Italy
facility: AO Arcispedale S.Maria Nuova Ematologia
city: Roma
country: Italy
facility: Università La Sapienza Ematologia
city: Rozzano (MI)
country: Italy
facility: Istituto Clinica Humanitas
city: Sassari
country: Italy
facility: AO Universitaria di Sassari Istituto di Ematologia
city: Siena
country: Italy
facility: Policlinico Le Scotte Clinica Ematologica
city: Torino
country: Italy
facility: Osp. San Giovanni Battista Ematologia2
city: Tricase (LE)
country: Italy
facility: Osp. Cardinalle Panico Divisione di Ematologia
city: Udine
country: Italy
facility: AO Universitaria clinica Ematologica ed Unità terapie Cellulari Carlo Melzi
Study officials:
affiliation: Ospedale S. Maria della Misericordia, Udine
name: Francesco Zaja, MD
role: STUDY_DIRECTOR
References:
citation: Zaja F, De Luca S, Vitolo U, Orsucci L, Levis A, Salvi F, Rusconi C, Ravelli E, Tucci A, Bottelli C, Balzarotti M, Brusamolino E, Bonfichi M, Pileri SA, Sabattini E, Volpetti S, Monagheddu C, Vacca A, Ria R, Fanin R. Salvage treatment with lenalidomide and dexamethasone in relapsed/refractory mantle cell lymphoma: clinical results and effects on microenvironment and neo-angiogenic biomarkers. Haematologica. 2012 Mar;97(3):416-22. doi: 10.3324/haematol.2011.051813. Epub 2011 Nov 4.