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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2014