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

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: NCT00424229
Recruitment Status : Unknown
Verified January 2007 by Groupe Francophone des Myelodysplasies.
Recruitment status was:  Recruiting
First Posted : January 18, 2007
Last Update Posted : March 12, 2007
Information provided by:
Groupe Francophone des Myelodysplasies

Brief 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]

Condition or disease Intervention/treatment Phase
Myelodysplastic Syndromes Drug: LENALIDOMIDE Phase 2

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).

Study Type : Interventional  (Clinical Trial)
Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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]
Study Start Date : October 2006
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

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

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:

  • 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

Exclusion Criteria:

  • 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

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): NCT00424229

Contact: .Pierre FENAUX, Professor 0033148955070
Contact: Fatrima-Zohra HAMZA, CRA 0033148955890

CHU Angers Recruiting
Angers, France, 49033
Contact: Mathilde HUNAULT-BERGER, MD    0033241354475   
Principal Investigator: HUNAULT-BERGER, MD         
CHRU Hurriez Recruiting
Lille, France, 59057
Contact: Bruno QUESNEL, Profesor    0033320446640   
Principal Investigator: QUESNEL, Professor         
Hopital Paoli Calmette Recruiting
Marseille, France, 13273
Contact: Norbert VEY, MD    0033431223695   
Principal Investigator: VEY, MD         
Sub-Investigator: CHARBONNIER, MD         
Sub-Investigator: GASTAUT, Professor         
Sub-Investigator: BOUABDALLAH, MD         
Sub-Investigator: REY, MD         
Sub-Investigator: STOPPA, MD         
Hopital Hotel Dieu Recruiting
Nantes, France, 44093
Contact: Jean-Luc HAROUSSEAU    0033240083271      
Principal Investigator: Jacques Delaunay         
Hopital Archet Recruiting
Nice, France, 06202
Contact: Laurence LEGROS    0033492035844   
Principal Investigator: LEGROS, MD         
Hoiptal St Louis Recruiting
Paris, France, 75475
Contact: Herve DOMBRET, Profesor    0033142499643   
Principal Investigator: Hervé Dombret         
Hopital Cochin Recruiting
Paris, France, 75679
Contact: Francois DREYFUS, Professor    003358412120   
Principal Investigator: DREYFUS, Professor         
Hopital Jean-Bernard Recruiting
Poitiers, France, 86021
Contact: Francois GUILHOT, Professor    0033549444201   
Principal Investigator: GUILHOT, Profesor         
Sub-Investigator: ROY, MD         
Centre Henry Becquerel Recruiting
Rouen, France, 76 038
Contact: Aspasia Stamatoullas, MD    33 2 32 08 22 88   
Principal Investigator: Aspasia Stamatoullas         
Chu Purpan Recruiting
Toulouse, France, 31059
Contact: Odile BEYNE-RAUZY, Doctor    0033561779679   
Principal Investigator: Odile BEYNE-RAUZY         
CHU Brabois Recruiting
Vandoeuvre, France, 54511
Contact: Agnes GUERCI-BRESLER, MD    0033383153281   
Principal Investigator: GUERCI-BRESLER, MD         
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Study Director: Pierre FENAUX, Profesor Groupe Francophone des Myelodysplasies
Study Director: Sara Burcheri Groupe français des myélodysplasies

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00424229     History of Changes
Other Study ID Numbers: GFM-REV-2006-02
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: March 12, 2007
Last Verified: January 2007

Keywords provided by Groupe Francophone des Myelodysplasies:

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents