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

Sponsor

Groupe Francophone des Myelodysplasies (Other)

Overall Status

Unknown status

CT.gov ID

NCT00424229

Collaborator

(none)

Enrollment

Locations

Duration (Months)

4.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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]

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes	Drug: LENALIDOMIDE	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Oct 1, 2006

Study Completion Date :

Oct 1, 2008

Outcome Measures

Primary Outcome Measures

Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
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
5	Hopital Archet	Nice	France	06202
6	Hoiptal St Louis	Paris	France	75475
7	Hopital Cochin	Paris	France	75679
8	Hopital Jean-Bernard	Poitiers	France	86021
9	Centre Henry Becquerel	Rouen	France	76 038
10	Chu Purpan	Toulouse	France	31059
11	CHU Brabois	Vandoeuvre	France	54511