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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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   (Adult, Senior)
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

Locations
France
CHU Angers
Angers, France, 49033
CHRU Hurriez
Lille, France, 59057
Hopital Paoli Calmette
Marseille, France, 13273
Hopital Hotel Dieu
Nantes, France, 44093
Hopital Archet
Nice, France, 06202
Hoiptal St Louis
Paris, France, 75475
Hopital Cochin
Paris, France, 75679
Hopital Jean-Bernard
Poitiers, France, 86021
Centre Henry Becquerel
Rouen, France, 76 038
Chu Purpan
Toulouse, France, 31059
CHU Brabois
Vandoeuvre, France, 54511
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

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:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Lenalidomide
Thalidomide
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

ClinicalTrials.gov processed this record on December 02, 2016