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

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

ChemIDplus related topics:

Cytarabine Cytarabine hydrochloride Bortezomib

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

Study ID Numbers:	GFM BAR-C-2005
First Received:	December 14, 2006
Last Updated:	March 9, 2007
ClinicalTrials.gov Identifier:	NCT00411905
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:

Myelodysplastic syndromes

Preleukemia

Precancerous Conditions

Hematologic Diseases

Bortezomib

Myelodysplasia

Myelodysplastic Syndromes

Bone Marrow Diseases

Cytarabine

Additional relevant MeSH terms:

Antimetabolites

Anti-Infective Agents

Disease

Antimetabolites, Antineoplastic

Immunologic Factors

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Antiviral Agents

Immunosuppressive Agents

Pharmacologic Actions

Protease Inhibitors

Neoplasms

Pathologic Processes

Syndrome

Therapeutic Uses

ClinicalTrials.gov processed this record on October 15, 2008

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