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

Phase 2

• Conditions: Myelodysplastic Syndromes

• Registration Number: NCT00424229
• Lead Sponsor: 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\[31\]

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 Timeline

• Study Start: 2006-10
• Status Verified: 2007-01
• Study First Submitted: 2007-01-15
• Study First Submitted QC: 2007-01-17
• Study First Posted: 2007-01-18
• Last Update Submitted: 2007-03-09
• Last Update Posted: 2007-03-12
• Study Completion: 2008-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 49

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement

Trial Locations

Locations (11)

Hopital Archet; 🇫🇷 Nice, France

CHRU Hurriez; 🇫🇷 Lille, France

CHU Angers; 🇫🇷 Angers, France

Hopital Hotel Dieu; 🇫🇷 Nantes, France

Hopital Cochin; 🇫🇷 Paris, France

Hopital Paoli Calmette; 🇫🇷 Marseille, France

Hoiptal St Louis; 🇫🇷 Paris, France

Chu Purpan; 🇫🇷 Toulouse, France

CHU Brabois; 🇫🇷 Vandoeuvre, France

Centre Henry Becquerel; 🇫🇷 Rouen, France

Hopital Jean-Bernard; 🇫🇷 Poitiers, France