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

Myelodysplastic Syndromes Clinical Trial

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]

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00424229
• Other study ID #: GFM-REV-2006-02
• Status: Recruiting
• Phase: Phase 2
• First received: January 15, 2007
• Last updated: March 9, 2007
• Start date: October 2006
• Est. completion date: October 2008

Study information

• Verified date: January 2007
• Source: Groupe Francophone des Myelodysplasies
• Contact: .Pierre FENAUX, Professor
• Phone: 0033148955070
• Email: pierre.fenaux[@]avc.aphp.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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]

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Preleukemia

Intervention

Drug:
• LENALIDOMIDE

Locations

Country	Name	City	State
France	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	Vandoeuvre

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Francophone des Myelodysplasies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement