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

Purpose

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	Intervention	Phase
Myelodysplastic Syndromes	Drug: LENALIDOMIDE	Phase II

ChemIDplus related topics:

Lenalidomide CC 5013

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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]

Further study details as provided by Groupe Francophone des Myelodysplasies:

Primary Outcome Measures:

Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement

Estimated Enrollment:	49
Study Start Date:	October 2006
Estimated Study Completion Date:	October 2008

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424229

Contacts


Contact: .Pierre FENAUX, Professor	0033148955070	pierre.fenaux@avc.aphp.fr

Contact: Fatrima-Zohra HAMZA, CRA	0033148955890	fatima.hamza@aphp.fr

Locations


France
	Centre Henry Becquerel	Recruiting
	Rouen, France, 76 038
	Contact: Aspasia Stamatoullas, MD 33 2 32 08 22 88 aspsta@rouen.fnclcc.fr
	Principal Investigator: Aspasia Stamatoullas
	CHRU Hurriez	Recruiting
	Lille, France, 59057
	Contact: Bruno QUESNEL, Profesor 0033320446640 b-quesnel@chru.fr
	Principal Investigator: QUESNEL, Professor
	CHU Angers	Recruiting
	Angers, France, 49033
	Contact: Mathilde HUNAULT-BERGER, MD 0033241354475 MHunault@chu-angers.fr
	Principal Investigator: HUNAULT-BERGER, MD
	CHU Brabois	Recruiting
	Vandoeuvre, France, 54511
	Contact: Agnes GUERCI-BRESLER, MD 0033383153281 a.guerci@chu-nancy.fr
	Principal Investigator: GUERCI-BRESLER, MD
	CHU PURPAN	Recruiting
	Toulouse, France, 31059
	Contact: Odile BEYNE-RAUZY, Doctor 0033561779679 beynerauzy.o@chu-toulouse.fr
	Principal Investigator: Odile BEYNE-RAUZY
	Hoiptal St Louis	Recruiting
	Paris, France, 75475
	Contact: Herve DOMBRET, Profesor 0033142499643 herve.dombret@sls.aphp.fr
	Principal Investigator: Hervé Dombret
	Hopital Cochin	Recruiting
	Paris, France, 75679
	Contact: Francois DREYFUS, Professor 003358412120 francois.dreyfus@cch.aphp.fr
	Principal Investigator: DREYFUS, Professor
	Hopital Jean-Bernard	Recruiting
	Poitiers, France, 86021
	Contact: Francois GUILHOT, Professor 0033549444201 f.guilhot@chu-poitiers.fr
	Principal Investigator: GUILHOT, Profesor
	Sub-Investigator: ROY, MD
	Hopital Paoli Calmette	Recruiting
	Marseille, France, 13273
	Contact: Norbert VEY, MD 0033431223695 veyn@marseille.fnclcc.fr
	Principal Investigator: VEY, MD
	Sub-Investigator: CHARBONNIER, MD
	Sub-Investigator: GASTAUT, Professor
	Sub-Investigator: BOUABDALLAH, MD
	Sub-Investigator: REY, MD
	Sub-Investigator: STOPPA, MD
	Hopital Hotel Dieu	Recruiting
	Nantes, France, 44093
	Contact: Jean-Luc HAROUSSEAU 0033240083271
	Principal Investigator: Jacques Delaunay
	Hopital Archet	Recruiting
	Nice, France, 06202
	Contact: Laurence LEGROS 0033492035844 legros.l@chu-nice.fr
	Principal Investigator: LEGROS, MD

Sponsors and Collaborators

Groupe Francophone des Myelodysplasies

Investigators


Study Director:	Pierre FENAUX, Profesor	Groupe Francophone des Myelodysplasies

Study Director:	Sara Burcheri	Groupe français des myélodysplasies

More Information

Study ID Numbers:	GFM-REV-2006-02
First Received:	January 15, 2007
Last Updated:	March 9, 2007
ClinicalTrials.gov Identifier:	NCT00424229
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe Francophone des Myelodysplasies:

MDS INT-2MDS HIGH RISKDELETION 5q[31]Lenalidomide

Study placed in the following topic categories:

Myelodysplastic syndromes

Preleukemia

Precancerous Conditions

Hematologic Diseases

Myelodysplasia

Myelodysplastic Syndromes

Lenalidomide

Bone Marrow Diseases

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Disease

Antineoplastic Agents

Therapeutic Uses

Syndrome

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 03, 2008

Sponsored by:	Groupe Francophone des Myelodysplasies
Information provided by:	Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier:	NCT00424229