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

Sponsored by:	Groupe Francophone des Myelodysplasies
Information provided by:	Groupe Francophone des Myelodysplasies
ClinicalTrials.gov Identifier:	NCT00411905

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 I Phase II

MedlinePlus related topics: Bone Marrow Diseases

Drug Information available for: Cytarabine hydrochloride Bortezomib Cytarabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes

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
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
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
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
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
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 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
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
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
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
Centre Henry Becquerel	Active, not recruiting
ROUEN, France, 76038
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
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
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

Sponsors and Collaborators

Groupe Francophone des Myelodysplasies

Investigators

Principal Investigator:

Francois DREYFUS, MD PhD

Groupe francaise des Myelodysplasies

More Information

No publications provided

Study ID Numbers:	GFM BAR-C-2005
Study First Received:	December 14, 2006
Last Updated:	March 9, 2007
ClinicalTrials.gov Identifier:	NCT00411905 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe Francophone des Myelodysplasies:

Myelodysplastic syndromes
IPSS Int-2 and High risk
Bortezomib
Low dose Cytarabine
Bone Marrow diseases

Study placed in the following topic categories:

Antimetabolites
Preleukemia
Immunologic Factors
Precancerous Conditions
Hematologic Diseases
Bortezomib

Myelodysplastic Syndromes
Bone Marrow Diseases
Immunosuppressive Agents
Antiviral Agents
Cytarabine
Protease Inhibitors

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Disease
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Precancerous Conditions
Antineoplastic Agents
Hematologic Diseases
Physiological Effects of Drugs
Myelodysplastic Syndromes
Bortezomib

Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Protease Inhibitors
Preleukemia
Neoplasms
Pathologic Processes
Therapeutic Uses
Syndrome
Bone Marrow Diseases
Cytarabine

ClinicalTrials.gov processed this record on May 06, 2009