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MANTLE CELL LYMPHOMAPhase 2NCT00786851

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

A Phase 2 study testing Lenalidomide and Dexametasone in people with MANTLE CELL LYMPHOMA, run by Fondazione Italiana Linfomi - ETS at 17 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
MANTLE CELL LYMPHOMA
What is being tested?
Lenalidomide and Dexametasone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
17 sitesItaly
Study dates
Jul 2008to Aug 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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;

Who cannot join

  • 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;
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  • 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;

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Italy17 sites

  • Ospedale SS. Antonio Biagio e Cesare Arrigo

    Alessandria

  • Centro diriferimento oncologico

    Aviano (PN)

  • Ematologia Spedali Civili

    Brescia

  • Ematologia Ospedale Businco

    Cagliari

  • Fondazione IRCCS UO Ematologia 1

    Milan

  • Ospedale Niguarda Cà granda

    Milan

  • Ospedale San Raffaele Ematologia

    Milan

  • Università Policlinico San Matteo Divione di Ematologia

    Pavia

  • AO Bianchi Melacrino Morelli UO Ematologia

    Reggio Calabria

  • AO Arcispedale S.Maria Nuova Ematologia

    Reggio Emilia

  • Università La Sapienza Ematologia

    Roma

  • Istituto Clinica Humanitas

    Rozzano (MI)

  • AO Universitaria di Sassari Istituto di Ematologia

    Sassari

  • Policlinico Le Scotte Clinica Ematologica

    Siena

  • Osp. San Giovanni Battista Ematologia2

    Torino

  • Osp. Cardinalle Panico Divisione di Ematologia

    Tricase (LE)

  • AO Universitaria clinica Ematologica ed Unità terapie Cellulari Carlo Melzi

    Udine

Other trials in Italy

About this study

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

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).

Being tested
Lenalidomide and Dexametasone
Keywords
MANTLE CELL LYMPHOMA (MCL), Lenalidomide (Len), Dexamethasone (Dex)
Medical subject headings
Lymphoma, Mantle-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT00786851
Study groupRoleWhat they receive
1ExperimentalLenalidomide 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).
Receives: Drug: Lenalidomide and Dexametasone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 3 years

Secondary outcomes (3)

  1. To explore the safety profile;

    Measured: 2 years

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

    Measured: 2 years

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

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJul 2010
  4. Study completionAug 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00786851
Sponsor's protocol ID
IIL LEN-DEX MCL 07
Other IDs
EudraCT Number 2008-000044-14
Status last verified
Aug 2016
First submitted
5 Nov 2008
Last updated
17 Aug 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 22058200

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenalidomide and Dexametasone in people with MANTLE CELL LYMPHOMA, run by Fondazione Italiana Linfomi - ETS at 17 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00786851, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.

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