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Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Groupe Francophone des Myelodysplasies.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier:
NCT00411905
First received: December 14, 2006
Last updated: March 9, 2007
Last verified: December 2006
History of Changes
  Purpose

We are evaluating the efficacy of the association of Low dose Cytarabine in association with Bortezomib in the treatment of patients diagnosed with high risk Myelodysplastic syndromes. Our aim is to decrease transfusion requirements and if possible induce a complete or at least a partial remission.


Condition Intervention Phase
Myelodysplastic Syndromes
 Drug: Bortezomib
 Phase 1
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 I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Groupe Francophone des Myelodysplasies:

Primary Outcome Measures:
  • Complete Response
  • Partial Response

Secondary Outcome Measures:
  • Hematological Improvement

Estimated Enrollment: 39
Study Start Date: June 2006
Estimated Study Completion Date: June 2006
Detailed Description:

Four cycles of treatment are proposed at 28 day intervals in an ambulatory setting

Cycle 1 :

  • Cytarabine 10 mg /m2/day subcutaneous injection for 14 days
  • Bortézomib 1,5mg/m2 days 1,4,8,11

Cycles 2, 3, 4 :

  • Cytarabine 20 mg /m2/j subcutaneous injections for 14 days
  • Bortézomib 1,5mg/m2 days 1,4,8,11

Bone marrow aspirates are evaluated just before the first cycle, after the second and after the fourth cycles

Responding patients may continue the treatment for 2 further cycles

  Eligibility

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

Inclusion Criteria:

  • MDS with IPSS scores Int-2 or High
  • Life expectancy greater than 6 months
  • No other available treatment options

Exclusion Criteria:

  • MDS with IPSS scores Low or Int-1
  • > 30% bone marrow blasts
  • clinical neuropathy of greater than grade 2
  • ECOG Score 3 or 4
  • Creatinine clearance of < 30 ml/min
  • LMMC
  • Pregnant patients or lactating mothers
  • Patients having received intensive chemotherapy in the 3 months prior to inclusion
  • Patients with uncontrolled pulmonary, cardiac, neurological, gastro-intestinal or genito-urinary disorders
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411905

Contacts
Contact: Shanti Natarajan-Amé, MD 00 33 3 88 12 76 70 shanti.ame@chru-strasbourg.fr
Contact: Marjorie Sidhoum, CRA 00 33 3 88 12 81 48 marjorie.sidhoum@chru-strasbourg.fr

Locations
France
CHU Angers Not yet recruiting
Angers, France, 43033
Contact: Mathilde HUNAULT-BERGER, Professor     00 33 241354475     MaHunault@chu-angers.fr    
Contact: Martine Gardembas-Pain, MD     00 33 241354705     MaGardembas@chu-angers.fr    
Principal Investigator: Mathilde HUNAULT-BERGER, MD PhD            
Hopital Avicenne Recruiting
Bobigny, France, 93009
Contact: Pierre FENAUX, MD     00 33 1 48 95 70 50     pierre.fenaux@avc.aphp.fr    
Contact: Fatima Hamza, CRA     00 33 1 48 95 58 90     fatima.hamza@avc.aphp.fr    
Principal Investigator: Pierre FENAUX, MD PhD            
Institut Bergonie Not yet recruiting
Bordeaux, France, 33076
Contact: Josy REIFFERS, Profesor     00 33 05 56 33 33 00     reiffers@bergonie.org    
Contact: Gabriel ETIENNE, MD     00 33 5 56 33 44 19     gabriel.etienne@chu-bordeaux.fr    
Principal Investigator: Josy Reiffers, Profesor            
Sub-Investigator: Gabriel ETIENNE, MD            
CHU de Caen Not yet recruiting
Caen, France, 14033
Contact: Stéphane CHEZE, MD     00 33 2 31 27 23 60     cheze-s@chu-caen.fr    
Principal Investigator: Stéphane CHEZE, MD            
CHU Dijon Recruiting
Dijon, France, 21000
Contact: Elisabeth BERGER, MD     00 33 3 80 29 50 41     elisabeth.berger@chu-dijon.fr    
Contact: Monique Grandjean, CRE     00 33 80 29 50 47     monique.grandjean@chu-dijon.fr    
Sub-Investigator: Eric SOLARY, MD            
Principal Investigator: Elisabeth BERGER, MD            
CHU Albert Michallon Recruiting
Grenoble, France, 38043
Contact: Jean-Yves CAHN, Professor     00 33 4 76 76 94 45     JYCahn@chu-grenoble.fr    
Contact: Stephane COURBY, MD     00 33 4 76 76 59 53     Scourby@chu-grenoble.fr    
Principal Investigator: Jean-Yves CAHN, MD            
CHU de Limoges Not yet recruiting
Limoges, France, 87046
Contact: Dominique BORDESSOULE, Profesor     00 33 5 55 05 66 42     bordessoule@unilim.fr    
Principal Investigator: Dominique BORDESSOULE, Profesor            
Hopital Paoli Calmette Recruiting
Marseille, France, 13273
Contact: Norbert VEY, MD     00 33 4 31 22 36 95     veyn@marseille.fnclcc.fr    
Principal Investigator: Norbert VEY, MD            
Sub-Investigator: Aude CHARBONNIER, MD            
Sub-Investigator: Reda BOUABDALLAH, MD            
CHU Archet Not yet recruiting
Nice, France, 06202
Contact: Laurence LEGROS, DOCTOR     00 33 4 92 03 58 44     legros@nice.fr    
Principal Investigator: Laurence LEGROS, MD            
Hopital Cochin Recruiting
Paris, France, 75014
Contact: FRANCOIS DREYFUS, Profesor     00 33 1 58 41 21 20     francois.dreyfus@ch.aphp.fr    
Contact: Nathalie Klein, CRE     00 33 1 58 41 20 44     nathalie.klein@cch.aphp.fr    
Principal Investigator: François DREYFUS, Profesor            
Centre Hospitalier Joffre Not yet recruiting
Perpignan, France, 66046
Contact: Laurence Sanhes, MD     00 33 468616448     laurence.sanhes@ch-perpignan.fr    
Principal Investigator: Laurence Sanhes, MD            
Centre Henry Becquerel Active, not recruiting
Rouen, France, 76038
Centre Hospitalier Universitaire de STRASBOURG Recruiting
Strasbourg, France, 67098
Contact: Shanti NATARAJAN-AME, MD     00 33 3 88 12 76 70     shanti.ame@chru-strasbourg.fr    
Contact: Marjorie SIDHOUM, CRA     00 33 3 88 12 81 48     marjorie.sidhoum@chru-strasbourg.fr    
Principal Investigator: Shanti NATARAJAN-AME, MD            
CHU Purpan Not yet recruiting
Toulouse, France, 31059
Contact: Guy Laurent, MD     00 33 5 61 77 20 78     beynerauzy.o@chu-toulouse.fr    
Principal Investigator: Guy LAURENT, MD            
Sub-Investigator: Odile BEYNE-RAUZY, MD            
CHU Brabois Recruiting
Vandoeuvre, France, 54511
Contact: Agnes GUERCI-BRESLER, MD     00 33 3 83 15 3281     a.guerci@chu-nancy.fr    
Principal Investigator: Agnes GUERCI-BRESLER, MD            
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Investigators
Principal Investigator: Francois DREYFUS, MD PhD Groupe francaise des Myelodysplasies
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00411905     History of Changes
Other Study ID Numbers: GFM BAR-C-2005
Study First Received: December 14, 2006
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:
Myelodysplastic syndromes
IPSS Int-2 and High risk
Bortezomib
Low dose Cytarabine
Bone Marrow diseases

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Preleukemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Cytarabine
Bortezomib
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013