Lenalidomide in Subjects With intermediate2 or High MDS Associated With a Deletion (DEL) 5q [31]
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Groupe Francophone des Myelodysplasies.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Groupe Francophone des Myelodysplasies
Information provided by:
Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier:
NCT00424229
First received: January 15, 2007
Last updated: March 9, 2007
Last verified: January 2007
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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] |
Resource links provided by NLM:
MedlinePlus related topics:
Myelodysplastic Syndromes
Drug Information available for:
Lenalidomide
U.S. FDA Resources
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 |
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 | |
| CHU Angers | Recruiting |
| Angers, France, 49033 | |
| Contact: Mathilde HUNAULT-BERGER, MD 0033241354475 MHunault@chu-angers.fr | |
| Principal Investigator: HUNAULT-BERGER, MD | |
| CHRU Hurriez | Recruiting |
| Lille, France, 59057 | |
| Contact: Bruno QUESNEL, Profesor 0033320446640 b-quesnel@chru.fr | |
| Principal Investigator: QUESNEL, Professor | |
| 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 | |
| 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 | |
| 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 | |
| Chu Purpan | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Odile BEYNE-RAUZY, Doctor 0033561779679 beynerauzy.o@chu-toulouse.fr | |
| Principal Investigator: Odile BEYNE-RAUZY | |
| CHU Brabois | Recruiting |
| Vandoeuvre, France, 54511 | |
| Contact: Agnes GUERCI-BRESLER, MD 0033383153281 a.guerci@chu-nancy.fr | |
| Principal Investigator: GUERCI-BRESLER, 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
No publications provided by Groupe Francophone des Myelodysplasies
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00424229 History of Changes |
| Other Study ID Numbers: | GFM-REV-2006-02 |
| Study First Received: | January 15, 2007 |
| Last Updated: | March 9, 2007 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Groupe Francophone des Myelodysplasies:
|
MDS INT-2MDS HIGH RISKDELETION 5q[31]Lenalidomide |
Additional relevant MeSH terms:
|
Myelodysplastic Syndromes Preleukemia Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms Lenalidomide Thalidomide Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013