Salvage Treatment With Lenalidomide and Dexamethaosne (LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)

MANTLE CELL LYMPHOMA Clinical Trial

Official title:

Salvage Treatment With Lenalidomide and Dexamethaosne(LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786851
• Other study ID #: IIL LEN-DEX MCL 07
• Secondary ID: EudraCT Number 2
• Status: Completed
• Phase: Phase 2
• First received: November 5, 2008
• Last updated: August 16, 2016
• Start date: July 2008
• Est. completion date: August 2011

Study information

• Verified date: August 2016
• Source: Fondazione Italiana Linfomi ONLUS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• MANTLE CELL LYMPHOMA

Intervention

Drug:
• Lenalidomide and Dexametasone
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).

Locations

Country	Name	City	State
Italy	Ospedale SS. Antonio Biagio e Cesare Arrigo	Alessandria
Italy	Centro diriferimento oncologico	Aviano (PN)
Italy	Ematologia Spedali Civili	Brescia
Italy	Ematologia Ospedale Businco	Cagliari
Italy	Fondazione IRCCS UO Ematologia 1	Milano
Italy	Ospedale Niguarda Cà granda	Milano
Italy	Ospedale San Raffaele Ematologia	Milano
Italy	Università Policlinico San Matteo Divione di Ematologia	Pavia
Italy	AO Bianchi Melacrino Morelli UO Ematologia	Reggio Calabria
Italy	AO Arcispedale S.Maria Nuova Ematologia	Reggio Emilia
Italy	Università La Sapienza Ematologia	Roma
Italy	Istituto Clinica Humanitas	Rozzano (MI)
Italy	AO Universitaria di Sassari Istituto di Ematologia	Sassari
Italy	Policlinico Le Scotte Clinica Ematologica	Siena
Italy	Osp. San Giovanni Battista Ematologia2	Torino
Italy	Osp. Cardinalle Panico Divisione di Ematologia	Tricase (LE)
Italy	AO Universitaria clinica Ematologica ed Unità terapie Cellulari Carlo Melzi	Udine

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Italiana Linfomi ONLUS	Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		3 years	Yes
Secondary	To explore the safety profile;		2 years	Yes
Secondary	To explore the modification of tumoral neo-angiogenic biomarkers and the relationship with response to Len-Dex therapy;		2 years	Yes
Secondary	To evaluate the clinical efficacy of Len-Dex in terms of response duration (RD) and overall survival (OS).		2 years	Yes