Lenalidomide in Subjects With intermediate2 or High MDS Associated With a Deletion (DEL) 5q [31]
NCT ID: NCT00424229
Last Updated: 2007-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
49 participants
INTERVENTIONAL
2006-10-31
2008-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] Abnormality
NCT00179621
Safety of Lenalidomide and Markers for Disease Progression in Patients With International Prognostic Scoring System (IPSS) Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) With Isolated del5q
NCT01081431
Lenalidomide in High-risk MDS and AML With Del(5q) or Monosomy 5
NCT00761449
Non-interventional Study of Lenalidomide in the Clinical Routine Treatment of TD Patients With IPSS Low or Int-1 MDS and Isolated Del(5q)
NCT02279654
Lenalidomide in Subject With Low and Intermediate-1 Risk MDS and Without Chromosome 5 Abnormality.
NCT01718379
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LENALIDOMIDE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Groupe Francophone des Myelodysplasies
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pierre FENAUX, Profesor
Role: STUDY_DIRECTOR
Groupe Francophone des Myelodysplasies
Sara Burcheri
Role: STUDY_DIRECTOR
Groupe français des myélodysplasies
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Angers
Angers, , France
CHRU Hurriez
Lille, , France
Hopital Paoli Calmette
Marseille, , France
Hopital Hotel Dieu
Nantes, , France
Hopital Archet
Nice, , France
Hoiptal St Louis
Paris, , France
Hopital Cochin
Paris, , France
Hopital Jean-Bernard
Poitiers, , France
Centre Henry Becquerel
Rouen, , France
Chu Purpan
Toulouse, , France
CHU Brabois
Vandœuvre-lès-Nancy, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Jean-Luc HAROUSSEAU
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Ades L, Boehrer S, Prebet T, Beyne-Rauzy O, Legros L, Ravoet C, Dreyfus F, Stamatoullas A, Chaury MP, Delaunay J, Laurent G, Vey N, Burcheri S, Mbida RM, Hoarau N, Gardin C, Fenaux P. Efficacy and safety of lenalidomide in intermediate-2 or high-risk myelodysplastic syndromes with 5q deletion: results of a phase 2 study. Blood. 2009 Apr 23;113(17):3947-52. doi: 10.1182/blood-2008-08-175778. Epub 2008 Nov 5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GFM-REV-2006-02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.