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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Groupe Francophone des Myelodysplasies.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier:
NCT00424229
First received: January 15, 2007
Last updated: March 9, 2007
Last verified: January 2007
  Purpose

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 Intervention Phase
Myelodysplastic Syndromes
Drug: LENALIDOMIDE
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: 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]

Resource links provided by NLM:


Further study details as provided by Groupe Francophone des Myelodysplasies:

Primary Outcome Measures:
  • Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement

Estimated Enrollment: 49
Study Start Date: October 2006
Estimated Study Completion Date: October 2008
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00424229

Contacts
Contact: .Pierre FENAUX, Professor 0033148955070 pierre.fenaux@avc.aphp.fr
Contact: Fatrima-Zohra HAMZA, CRA 0033148955890 fatima.hamza@aphp.fr

Locations
France
CHU Angers Recruiting
Angers, France, 49033
Contact: Mathilde HUNAULT-BERGER, MD    0033241354475    MHunault@chu-angers.fr   
Principal Investigator: HUNAULT-BERGER, MD         
CHRU Hurriez Recruiting
Lille, France, 59057
Contact: Bruno QUESNEL, Profesor    0033320446640    b-quesnel@chru.fr   
Principal Investigator: QUESNEL, Professor         
Hopital Paoli Calmette Recruiting
Marseille, France, 13273
Contact: Norbert VEY, MD    0033431223695    veyn@marseille.fnclcc.fr   
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    legros.l@chu-nice.fr   
Principal Investigator: LEGROS, MD         
Hoiptal St Louis Recruiting
Paris, France, 75475
Contact: Herve DOMBRET, Profesor    0033142499643    herve.dombret@sls.aphp.fr   
Principal Investigator: Hervé Dombret         
Hopital Cochin Recruiting
Paris, France, 75679
Contact: Francois DREYFUS, Professor    003358412120    francois.dreyfus@cch.aphp.fr   
Principal Investigator: DREYFUS, Professor         
Hopital Jean-Bernard Recruiting
Poitiers, France, 86021
Contact: Francois GUILHOT, Professor    0033549444201    f.guilhot@chu-poitiers.fr   
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    aspsta@rouen.fnclcc.fr   
Principal Investigator: Aspasia Stamatoullas         
Chu Purpan Recruiting
Toulouse, France, 31059
Contact: Odile BEYNE-RAUZY, Doctor    0033561779679    beynerauzy.o@chu-toulouse.fr   
Principal Investigator: Odile BEYNE-RAUZY         
CHU Brabois Recruiting
Vandoeuvre, France, 54511
Contact: Agnes GUERCI-BRESLER, MD    0033383153281    a.guerci@chu-nancy.fr   
Principal Investigator: GUERCI-BRESLER, MD         
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Investigators
Study Director: Pierre FENAUX, Profesor Groupe Francophone des Myelodysplasies
Study Director: Sara Burcheri Groupe français des myélodysplasies
  More Information

No publications provided by Groupe Francophone des Myelodysplasies

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00424229     History of Changes
Other Study ID Numbers: GFM-REV-2006-02
Study First Received: January 15, 2007
Last Updated: March 9, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Groupe Francophone des Myelodysplasies:
MDS INT-2MDS HIGH RISKDELETION 5q[31]Lenalidomide

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Lenalidomide
Thalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014