Clinical trial NCT00424229: Lenalidomide in Subjects With intermediate2 or High MDS Associated With a Deletion (DEL) 5q [31]
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]
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Myelodysplastic Syndromes
Keywords: MDS INT-2MDS HIGH RISKDELETION 5q[31]Lenalidomide
Lead sponsor: Groupe Francophone des Myelodysplasies
Sponsor class: OTHER
First posted: 2007-01-18
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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

Primary outcomes:
measure: Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Lille
country: France
facility: CHRU Hurriez
city: Marseille
country: France
facility: Hopital Paoli Calmette
city: Nantes
country: France
facility: Hopital Hotel Dieu
city: Nice
country: France
facility: Hopital Archet
city: Paris
country: France
facility: Hoiptal St Louis
city: Paris
country: France
facility: Hopital Cochin
city: Poitiers
country: France
facility: Hopital Jean-Bernard
city: Rouen
country: France
facility: Centre Henry Becquerel
city: Toulouse
country: France
facility: Chu Purpan
city: Vandoeuvre
country: France
facility: CHU Brabois
Study officials:
affiliation: Groupe Francophone des Myelodysplasies
name: Pierre FENAUX, Profesor
role: STUDY_DIRECTOR
affiliation: Groupe français des myélodysplasies
name: Sara Burcheri
role: STUDY_DIRECTOR
References:
citation: 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.