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

Primary Purpose

Myelodysplastic Syndromes

Status

Unknown status

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

LENALIDOMIDE

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring MDS INT-2MDS HIGH RISKDELETION 5q[31]Lenalidomide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Outcomes

Primary Outcome Measures

Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement

Secondary Outcome Measures

Full Information

NCT ID

NCT00424229

First Posted

January 15, 2007

Last Updated

March 9, 2007

Sponsor

Groupe Francophone des Myelodysplasies

1. Study Identification

Unique Protocol Identification Number

NCT00424229

Brief Title

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

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Unknown status

Study Start Date

October 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

October 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Groupe Francophone des Myelodysplasies

4. Oversight

Data Monitoring Committee

5. 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]

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myelodysplastic Syndromes

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

49 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

LENALIDOMIDE

Primary Outcome Measure Information:

Title

Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

.Pierre FENAUX, Professor

Phone

0033148955070

pierre.fenaux@avc.aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

Fatrima-Zohra HAMZA, CRA

Phone

0033148955890

fatima.hamza@aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pierre FENAUX, Profesor

Organizational Affiliation

Groupe Francophone des Myelodysplasies

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sara Burcheri

Organizational Affiliation

Groupe français des myélodysplasies

Official's Role

Study Director

Facility Information:

Facility Name

CHU Angers

City

Angers

ZIP/Postal Code

49033

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mathilde HUNAULT-BERGER, MD

Phone

0033241354475

MHunault@chu-angers.fr

First Name & Middle Initial & Last Name & Degree

HUNAULT-BERGER, MD

Facility Name

CHRU Hurriez

City

Lille

ZIP/Postal Code

59057

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bruno QUESNEL, Profesor

Phone

0033320446640

b-quesnel@chru.fr

First Name & Middle Initial & Last Name & Degree

QUESNEL, Professor

Facility Name

Hopital Paoli Calmette

City

Marseille

ZIP/Postal Code

13273

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Norbert VEY, MD

Phone

0033431223695

veyn@marseille.fnclcc.fr

First Name & Middle Initial & Last Name & Degree

VEY, MD

First Name & Middle Initial & Last Name & Degree

CHARBONNIER, MD

First Name & Middle Initial & Last Name & Degree

GASTAUT, Professor

First Name & Middle Initial & Last Name & Degree

BOUABDALLAH, MD

First Name & Middle Initial & Last Name & Degree

REY, MD

First Name & Middle Initial & Last Name & Degree

STOPPA, MD

Facility Name

Hopital Hotel Dieu

City

Nantes

ZIP/Postal Code

44093

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jean-Luc HAROUSSEAU

Phone

0033240083271

First Name & Middle Initial & Last Name & Degree

Jacques Delaunay

Facility Name

Hopital Archet

City

Nice

ZIP/Postal Code

06202

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laurence LEGROS

Phone

0033492035844

legros.l@chu-nice.fr

First Name & Middle Initial & Last Name & Degree

LEGROS, MD

Facility Name

Hoiptal St Louis

City

Paris

ZIP/Postal Code

75475

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Herve DOMBRET, Profesor

Phone

0033142499643

herve.dombret@sls.aphp.fr

First Name & Middle Initial & Last Name & Degree

Hervé Dombret

Facility Name

Hopital Cochin

City

Paris

ZIP/Postal Code

75679

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francois DREYFUS, Professor

Phone

003358412120

francois.dreyfus@cch.aphp.fr

First Name & Middle Initial & Last Name & Degree

DREYFUS, Professor

Facility Name

Hopital Jean-Bernard

City

Poitiers

ZIP/Postal Code

86021

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francois GUILHOT, Professor

Phone

0033549444201

f.guilhot@chu-poitiers.fr

First Name & Middle Initial & Last Name & Degree

GUILHOT, Profesor

First Name & Middle Initial & Last Name & Degree

ROY, MD

Facility Name

Centre Henry Becquerel

City

Rouen

ZIP/Postal Code

76 038

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aspasia Stamatoullas, MD

Phone

33 2 32 08 22 88

aspsta@rouen.fnclcc.fr

First Name & Middle Initial & Last Name & Degree

Aspasia Stamatoullas

Facility Name

Chu Purpan

City

Toulouse

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Odile BEYNE-RAUZY, Doctor

Phone

0033561779679

beynerauzy.o@chu-toulouse.fr

First Name & Middle Initial & Last Name & Degree

Odile BEYNE-RAUZY

Facility Name

CHU Brabois

City

Vandoeuvre

ZIP/Postal Code

54511

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Agnes GUERCI-BRESLER, MD

Phone

0033383153281

a.guerci@chu-nancy.fr

First Name & Middle Initial & Last Name & Degree

GUERCI-BRESLER, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

18987358

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.

Results Reference

derived

Learn more about this trial

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

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

Myelodysplastic Syndromes

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial