NCT00424229

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\[31\]

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2006

Geographic Reach
1 country

11 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 18, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

March 12, 2007

Status Verified

January 1, 2007

First QC Date

January 15, 2007

Last Update Submit

March 9, 2007

Conditions

Myelodysplastic Syndromes

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Primary: Complete Response; Partial ResponseSecondary: Hematological Improvement

Interventions

LENALIDOMIDEDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

CHU Angers

Angers, 49033, France

RECRUITING

CHRU Hurriez

Lille, 59057, France

RECRUITING

Hopital Paoli Calmette

Marseille, 13273, France

RECRUITING

Hopital Hotel Dieu

Nantes, 44093, France

RECRUITING

Hopital Archet

Nice, 06202, France

RECRUITING

Hoiptal St Louis

Paris, 75475, France

RECRUITING

Hopital Cochin

Paris, 75679, France

RECRUITING

Hopital Jean-Bernard

Poitiers, 86021, France

RECRUITING

Centre Henry Becquerel

Rouen, 76 038, France

RECRUITING

Chu Purpan

Toulouse, 31059, France

RECRUITING

CHU Brabois

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 18987358DERIVED

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pierre FENAUX, Profesor

    Groupe Francophone des Myelodysplasies

    STUDY DIRECTOR

  • Sara Burcheri

    Groupe français des myélodysplasies

    STUDY DIRECTOR

Central Study Contacts

.Pierre FENAUX, Professor

CONTACT

0033148955070pierre.fenaux@avc.aphp.fr

Fatrima-Zohra HAMZA, CRA

CONTACT

0033148955890fatima.hamza@aphp.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 15, 2007

First Posted

January 18, 2007

Study Start

October 1, 2006

Study Completion

October 1, 2008

Last Updated

March 12, 2007

Record last verified: 2007-01

Locations

FR(11)