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

March 9, 2007 updated by: Groupe Francophone des Myelodysplasies

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]

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France, 49033
        • Recruiting
        • CHU Angers
        • Contact:
        • Principal Investigator:
          • HUNAULT-BERGER, MD
      • Lille, France, 59057
        • Recruiting
        • CHRU Hurriez
        • Contact:
        • Principal Investigator:
          • QUESNEL, Professor
      • Marseille, France, 13273
        • Recruiting
        • Hopital Paoli Calmette
        • Contact:
        • Principal Investigator:
          • VEY, MD
        • Sub-Investigator:
          • CHARBONNIER, MD
        • Sub-Investigator:
          • GASTAUT, Professor
        • Sub-Investigator:
          • BOUABDALLAH, MD
        • Sub-Investigator:
          • REY, MD
        • Sub-Investigator:
          • STOPPA, MD
      • Nantes, France, 44093
        • Recruiting
        • Hôpital Hotel Dieu
        • Contact:
          • Jean-Luc HAROUSSEAU
          • Phone Number: 0033240083271
        • Principal Investigator:
          • Jacques Delaunay
      • Nice, France, 06202
        • Recruiting
        • Hôpital Archet
        • Contact:
        • Principal Investigator:
          • LEGROS, MD
      • Paris, France, 75679
        • Recruiting
        • Hopital Cochin
        • Contact:
        • Principal Investigator:
          • DREYFUS, Professor
      • Paris, France, 75475
        • Recruiting
        • Hoiptal St Louis
        • Contact:
        • Principal Investigator:
          • Herve Dombret
      • Poitiers, France, 86021
        • Recruiting
        • Hôpital Jean-Bernard
        • Contact:
        • Principal Investigator:
          • GUILHOT, Profesor
        • Sub-Investigator:
          • ROY, MD
      • Rouen, France, 76 038
        • Recruiting
        • Centre Henry Becquerel
        • Contact:
        • Principal Investigator:
          • Aspasia Stamatoullas
      • Toulouse, France, 31059
        • Recruiting
        • CHU Purpan
        • Contact:
        • Principal Investigator:
          • Odile BEYNE-RAUZY
      • Vandoeuvre, France, 54511
        • Recruiting
        • CHU Brabois
        • Contact:
        • Principal Investigator:
          • GUERCI-BRESLER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Francophone des Myelodysplasies

Investigators

  • Study Director: Pierre FENAUX, Profesor, Groupe Francophone des Myelodysplasies
  • Study Director: Sara Burcheri, Groupe Français des Myélodysplasies

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion

October 1, 2008

Study Registration Dates

First Submitted

January 15, 2007

First Submitted That Met QC Criteria

January 17, 2007

First Posted (Estimate)

January 18, 2007

Study Record Updates

Last Update Posted (Estimate)

March 12, 2007

Last Update Submitted That Met QC Criteria

March 9, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFM-REV-2006-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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