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Myelodysplastic SyndromesPhase 2NCT00424229

Lenalidomide in Subjects With intermediate2 or High MDS Associated With a Deletion (DEL) 5q [31]

A Phase 2 study testing LENALIDOMIDE in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 11 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

We are evaluating the incidence of significant hematological response, according to IWG criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response of patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring System [IPSS]) MDS with a deletion (del) 5q[31] Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myelodysplastic Syndromes
What is being tested?
LENALIDOMIDE
How many people
49 participants
Where
11 sitesFrance
Study dates
Oct 2006to Oct 2008
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

  • Age > 18 years at the time of signing the informed consent form
  • MDS with IPSS scores Int-2 or high with deletion 5q(31)
  • Prior thalidomide allowed
  • Documented diagnosis of MDS (RA, RARS, RAEB, RAEB-T and CMML with WBC < 13,000/mm3 according to FAB classification) that meets IPSS criteria for intermediate-2 or high-risk disease and has an associated del 5q[31] (the deleted chromosomal region must include 5q[31]), with or without additional cytogenetic abnormalities

Who cannot join

  • Pregnant or lactating females
  • Prior therapy with lenalidomide
  • MDS with IPSS scores low or Int-1
  • Clinical neuropathy of greater than grade 2
  • Proliferative (WBC ≥ 13,000/mL) chronic myelomonocytic leukemia (CMML)
  • Recombinant human erythropoietin (rHuEPO) therapy received within 28 days
  • Use of androgens other than for treating hypogonadism

Trial locations and contacts

11 sites in 1 country.

.Pierre FENAUX, Professor contact

0033148955070

pierre.fenaux@avc.aphp.fr

Fatrima-Zohra HAMZA, CRA contact

0033148955890

fatima.hamza@aphp.fr

11 sites in 1 country

France11 sites, 11 recruiting

  • CHU Angers

    Angers, 49033

    Mathilde HUNAULT-BERGER, MD, 0033241354475, MHunault@chu-angers.fr

    HUNAULT-BERGER, MD

    Recruiting

  • CHRU Hurriez

    Lille, 59057

    Bruno QUESNEL, Profesor, 0033320446640, b-quesnel@chru.fr

    QUESNEL, Professor

    Recruiting

  • Hopital Paoli Calmette

    Marseille, 13273

    Norbert VEY, MD, 0033431223695, veyn@marseille.fnclcc.fr

    VEY, MD

    Recruiting

  • Hopital Hotel Dieu

    Nantes, 44093

    Jean-Luc HAROUSSEAU, 0033240083271

    Jacques Delaunay

    Recruiting

  • Hopital Archet

    Nice, 06202

    Laurence LEGROS, 0033492035844, legros.l@chu-nice.fr

    LEGROS, MD

    Recruiting

  • Hoiptal St Louis

    Paris, 75475

    Herve DOMBRET, Profesor, 0033142499643, herve.dombret@sls.aphp.fr

    Hervé Dombret

    Recruiting

  • Hopital Cochin

    Paris, 75679

    Francois DREYFUS, Professor, 003358412120, francois.dreyfus@cch.aphp.fr

    DREYFUS, Professor

    Recruiting

  • Hopital Jean-Bernard

    Poitiers, 86021

    Francois GUILHOT, Professor, 0033549444201, f.guilhot@chu-poitiers.fr

    GUILHOT, Profesor

    Recruiting

  • Centre Henry Becquerel

    Rouen, 76 038

    Aspasia Stamatoullas, MD, 33 2 32 08 22 88, aspsta@rouen.fnclcc.fr

    Aspasia Stamatoullas

    Recruiting

  • Chu Purpan

    Toulouse, 31059

    Odile BEYNE-RAUZY, Doctor, 0033561779679, beynerauzy.o@chu-toulouse.fr

    Odile BEYNE-RAUZY

    Recruiting

  • CHU Brabois

    Vandœuvre-lès-Nancy, 54511

    Agnes GUERCI-BRESLER, MD, 0033383153281, a.guerci@chu-nancy.fr

    GUERCI-BRESLER, MD

    Recruiting

Other trials in France

About this study

Official title: Phase II Study of the Efficacy and Safety of Lenalidomide in Adult Subjects With Intermediate-2-or Higt Risk Myelodysplastic Syndrome(MDS) Associated With a Deletion (DEL) 5q [31]

We are evaluating the incidence of significant hematological response, according to IWG criteria including CR, PR or, major HI, (HI-E, Hl-N,or Hl- P), and cytogenetic response of patients diagnosed with intermediate-2 or high-risk (International Prognostic Scoring System [IPSS]) MDS with a deletion (del) 5q[31]

Read the detailed description

Subjects meeting all inclusion and exclusion criteria will receive lenalidomide

lenalidomide will be administered at 10 mg (two 5 mg capsules) once daily on Days 1-21, every 4 weeks.

Bone marrow aspirate (baseline and during the course of the study at week 8, 16, 32, 52 and when clinically indicated/for assessment of disease progression) evaluations

Subjects may participate in the study for up to 52 weeks ( in patients still responding after 52 weeks, the drug wil continue to be supplied).

Being tested
LENALIDOMIDE
Keywords
MDS INT-2MDS HIGH RISKDELETION 5q[31]Lenalidomide
Medical subject headings
Myelodysplastic Syndromes

What participants receive

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

What is being measured

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

  1. Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement

Timeline

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

  1. First posted18 Jan 2007 (estimated)
  2. Study startOct 2006
  3. Study completionOct 2008

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
49 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00424229
Sponsor's protocol ID
GFM-REV-2006-02
Status last verified
Jan 2007
First submitted
15 Jan 2007
Last updated
12 Mar 2007
Results posted
No
Data monitoring committee
No

Publications

  • Ades L, Boehrer S, Prebet T, Beyne-Rauzy O, Legros L, Ravoet C, Dreyfus F, Stamatoullas A, Chaury MP, Delaunay J, Laurent G, Vey N, Burcheri S, Mbida RM, Hoarau N, Gardin C, Fenaux P. Efficacy and safety of lenalidomide in intermediate-2 or high-risk myelodysplastic syndromes with 5q deletion: results of a phase 2 study. Blood. 2009 Apr 23;113(17):3947-52. doi: 10.1182/blood-2008-08-175778. Epub 2008 Nov 5.

    PubMed 18987358

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LENALIDOMIDE in people with Myelodysplastic Syndromes, run by Groupe Francophone des Myelodysplasies at 11 sites in France.

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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Mar 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. 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?

Results are not available in the source record.

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

Contact .Pierre FENAUX, Professor (0033148955070, pierre.fenaux@avc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement. 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 NCT00424229, 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 12 Mar 2007.

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