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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. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Groupe Francophone des Myelodysplasies.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: December 15, 2006
Last Update Posted: March 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Groupe Francophone des Myelodysplasies
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
Intervention Model: Single Group Assignment
Masking: None (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:

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00411905

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

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
Principal Investigator: Francois DREYFUS, MD PhD Groupe francaise des Myelodysplasies
  More Information

ClinicalTrials.gov Identifier: NCT00411905     History of Changes
Other Study ID Numbers: GFM BAR-C-2005
First Submitted: December 14, 2006
First Posted: December 15, 2006
Last Update Posted: March 12, 2007
Last Verified: December 2006

Keywords provided by Groupe Francophone des Myelodysplasies:
Myelodysplastic syndromes
IPSS Int-2 and High risk
Low dose Cytarabine
Bone Marrow diseases

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs