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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by Fondazione Italiana Linfomi ONLUS.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
Information provided by:
Fondazione Italiana Linfomi ONLUS
ClinicalTrials.gov Identifier:
NCT00786851
First received: November 5, 2008
Last updated: June 22, 2011
Last verified: November 2007
  Purpose

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 Intervention Phase
MANTLE CELL LYMPHOMA
Drug: Lenalidomide and Dexametasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Salvage Treatment With Lenalidomide and Dexamethaosne(LEN-DEX) in Patients With Relapsed/Refractory Mantle Cell Lymphoma (MCL)

Resource links provided by NLM:


Further study details as provided by Fondazione Italiana Linfomi ONLUS:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

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

Estimated Enrollment: 33
Study Start Date: July 2008
Estimated Study Completion Date: July 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786851

Locations
Italy
Ospedale SS. Antonio Biagio e Cesare Arrigo
Alessandria, Italy
Centro diriferimento oncologico
Aviano (PN), Italy
IRCC Istituto tumori Ematologia
Bari, Italy
Ematologia Spedali Civili
Brescia, Italy
Ematologia Ospedale Businco
Cagliari, Italy
Presidio Ospedaliero Garibaldi-Nesima UO Onco-Ematologia
Catania, Italy
Policlinico Careggi Clinica Ematologica
Firenze, Italy
Ospedale San Raffaele Ematologia
Milano, Italy
Ospedale Niguarda Cà granda
Milano, Italy
Fondazione IRCCS UO Ematologia 1
Milano, Italy
Università Federico II Ematologia
Napoli, Italy
Università Policlinico San Matteo Divione di Ematologia
Pavia, Italy
Osp. S.Maria delle Croci Ematologia
Ravenna, Italy
AO Bianchi Melacrino Morelli UO Ematologia
Reggio Calabria, Italy
AO Arcispedale S.Maria Nuova Ematologia
Reggio Emilia, Italy
Ospedale degli Infermi - Struttura Semplice di Ematologia
Rimini, Italy
Ospedale S.Eugenio Ematologia
Roma, 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
Azienda Ospedaliera S.Maria - S.C. Onco-Ematologia
Terni, Italy
Osp. San Giovanni Battista Ematologia2
Torino, Italy
Osp. Cà Foncello Ematologia
Treviso, 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
Investigators
Study Director: Francesco Zaja, MD Ospedale S. Maria della Misericordia, Udine
  More Information

No publications provided by Fondazione Italiana Linfomi ONLUS

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Francesco Zaja, Azienda Ospedaliera Universitaria S. Maria della Misericordia di Udine
ClinicalTrials.gov Identifier: NCT00786851     History of Changes
Other Study ID Numbers: IIL LEN-DEX MCL 07, EudraCT Number 2008−000044−14
Study First Received: November 5, 2008
Last Updated: June 22, 2011
Health Authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by Fondazione Italiana Linfomi ONLUS:
MANTLE CELL LYMPHOMA (MCL)
Lenalidomide (Len)
Dexamethasone (Dex)

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Dexamethasone
Lenalidomide
Thalidomide
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Anti-Bacterial Agents
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Growth Inhibitors
Growth Substances
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on November 25, 2014