NCT00786851

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2008

Typical duration for phase_2

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 6, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 17, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

November 5, 2008

Last Update Submit

August 16, 2016

Conditions

MANTLE CELL LYMPHOMA

Keywords

MANTLE CELL LYMPHOMA (MCL)Lenalidomide (Len)Dexamethasone (Dex)

Outcome Measures

Primary Outcomes (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

    3 years

Secondary Outcomes (3)

  • To explore the safety profile;

    2 years

  • To explore the modification of tumoral neo-angiogenic biomarkers and the relationship with response to Len-Dex therapy;

    2 years

  • To evaluate the clinical efficacy of Len-Dex in terms of response duration (RD) and overall survival (OS).

    2 years

Study Arms (1)

1

EXPERIMENTAL

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

Interventions

Lenalidomide and DexametasoneDRUG

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).

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • +4 more criteria

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Ospedale SS. Antonio Biagio e Cesare Arrigo

Alessandria, Italy

Location

Centro diriferimento oncologico

Aviano (PN), Italy

Location

Ematologia Spedali Civili

Brescia, Italy

Location

Ematologia Ospedale Businco

Cagliari, Italy

Location

Fondazione IRCCS UO Ematologia 1

Milan, Italy

Location

Ospedale Niguarda Cà granda

Milan, Italy

Location

Ospedale San Raffaele Ematologia

Milan, Italy

Location

Università Policlinico San Matteo Divione di Ematologia

Pavia, Italy

Location

AO Bianchi Melacrino Morelli UO Ematologia

Reggio Calabria, Italy

Location

AO Arcispedale S.Maria Nuova Ematologia

Reggio Emilia, Italy

Location

Università La Sapienza Ematologia

Roma, Italy

Location

Istituto Clinica Humanitas

Rozzano (MI), Italy

Location

AO Universitaria di Sassari Istituto di Ematologia

Sassari, Italy

Location

Policlinico Le Scotte Clinica Ematologica

Siena, Italy

Location

Osp. San Giovanni Battista Ematologia2

Torino, Italy

Location

Osp. Cardinalle Panico Divisione di Ematologia

Tricase (LE), Italy

Location

AO Universitaria clinica Ematologica ed Unità terapie Cellulari Carlo Melzi

Udine, Italy

Location

Related Publications (1)

  • 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.

    PMID: 22058200DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Francesco Zaja, MD

    Ospedale S. Maria della Misericordia, Udine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 6, 2008

Study Start

July 1, 2008

Primary Completion

July 1, 2010

Study Completion

August 1, 2011

Last Updated

August 17, 2016

Record last verified: 2016-08

Locations

IT(17)