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Trial record 14 of 854 for:    LENALIDOMIDE AND Angiogenesis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00786851
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : August 17, 2016
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by (Responsible Party):
Fondazione Italiana Linfomi ONLUS

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).

Condition or disease Intervention/treatment Phase
MANTLE CELL LYMPHOMA Drug: Lenalidomide and Dexametasone Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Salvage Treatment With Lenalidomide and Dexamethaosne(LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)
Study Start Date : July 2008
Actual Primary Completion Date : July 2010
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: 1
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).
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).

Primary Outcome Measures :
  1. 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 [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. To explore the safety profile; [ Time Frame: 2 years ]
  2. To explore the modification of tumoral neo-angiogenic biomarkers and the relationship with response to Len-Dex therapy; [ Time Frame: 2 years ]
  3. To evaluate the clinical efficacy of Len-Dex in terms of response duration (RD) and overall survival (OS). [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00786851

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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, Italy
Sponsors and Collaborators
Fondazione Italiana Linfomi ONLUS
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
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Study Director: Francesco Zaja, MD Ospedale S. Maria della Misericordia, Udine

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Fondazione Italiana Linfomi ONLUS Identifier: NCT00786851     History of Changes
Other Study ID Numbers: IIL LEN-DEX MCL 07
EudraCT Number 2008−000044−14
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: August 17, 2016
Last Verified: August 2016
Keywords provided by Fondazione Italiana Linfomi ONLUS:
Lenalidomide (Len)
Dexamethasone (Dex)
Additional relevant MeSH terms:
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Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunologic Factors
Growth Substances
Growth Inhibitors