Status:
UNKNOWN
Lenalidomide in Subjects With intermediate2 or High MDS Associated With a Deletion (DEL) 5q [31]
Lead Sponsor:
Groupe Francophone des Myelodysplasies
Conditions:
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 wi...
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 asp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
End Date :
October 1 2008
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00424229
Start Date
October 1 2006
End Date
October 1 2008
Last Update
March 12 2007
Active Locations (11)
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1
CHU Angers
Angers, France, 49033
2
CHRU Hurriez
Lille, France, 59057
3
Hopital Paoli Calmette
Marseille, France, 13273
4
Hopital Hotel Dieu
Nantes, France, 44093