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

Primary Purpose

Myelodysplastic Syndromes

Status
Unknown status
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Bortezomib
Sponsored by
Groupe Francophone des Myelodysplasies
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelodysplastic Syndromes focused on measuring Myelodysplastic syndromes, IPSS Int-2 and High risk, Bortezomib, Low dose Cytarabine, Bone Marrow diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Angers
  • Hopital AvicenneRecruiting
  • Institut Bergonie
  • CHU de Caen
  • CHU DijonRecruiting
  • CHU Albert MichallonRecruiting
  • CHU de Limoges
  • Hopital Paoli CalmetteRecruiting
  • CHU Archet
  • Hopital CochinRecruiting
  • Centre Hospitalier Joffre
  • Centre Henry Becquerel
  • Centre Hospitalier Universitaire de STRASBOURGRecruiting
  • CHU Purpan
  • CHU BraboisRecruiting

Outcomes

Primary Outcome Measures

Complete Response
Partial Response

Secondary Outcome Measures

Hematological Improvement

Full Information

First Posted
December 14, 2006
Last Updated
March 9, 2007
Sponsor
Groupe Francophone des Myelodysplasies
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1. Study Identification

Unique Protocol Identification Number
NCT00411905
Brief Title
Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes
Official Title
Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Groupe Francophone des Myelodysplasies

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndromes
Keywords
Myelodysplastic syndromes, IPSS Int-2 and High risk, Bortezomib, Low dose Cytarabine, Bone Marrow diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
39 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bortezomib
Primary Outcome Measure Information:
Title
Complete Response
Title
Partial Response
Secondary Outcome Measure Information:
Title
Hematological Improvement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shanti Natarajan-Amé, MD
Phone
00 33 3 88 12 76 70
Email
shanti.ame@chru-strasbourg.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marjorie Sidhoum, CRA
Phone
00 33 3 88 12 81 48
Email
marjorie.sidhoum@chru-strasbourg.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois DREYFUS, MD PhD
Organizational Affiliation
Groupe francaise des Myelodysplasies
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
43033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathilde HUNAULT-BERGER, Professor
Phone
00 33 241354475
Email
MaHunault@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Martine Gardembas-Pain, MD
Phone
00 33 241354705
Email
MaGardembas@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Mathilde HUNAULT-BERGER, MD PhD
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre FENAUX, MD
Phone
00 33 1 48 95 70 50
Email
pierre.fenaux@avc.aphp.fr
First Name & Middle Initial & Last Name & Degree
Fatima Hamza, CRA
Phone
00 33 1 48 95 58 90
Email
fatima.hamza@avc.aphp.fr
First Name & Middle Initial & Last Name & Degree
Pierre FENAUX, MD PhD
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josy REIFFERS, Profesor
Phone
00 33 05 56 33 33 00
Email
reiffers@bergonie.org
First Name & Middle Initial & Last Name & Degree
Gabriel ETIENNE, MD
Phone
00 33 5 56 33 44 19
Email
gabriel.etienne@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Josy Reiffers, Profesor
First Name & Middle Initial & Last Name & Degree
Gabriel ETIENNE, MD
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane CHEZE, MD
Phone
00 33 2 31 27 23 60
Email
cheze-s@chu-caen.fr
First Name & Middle Initial & Last Name & Degree
Stéphane CHEZE, MD
Facility Name
CHU Dijon
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth BERGER, MD
Phone
00 33 3 80 29 50 41
Email
elisabeth.berger@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Monique Grandjean, CRE
Phone
00 33 80 29 50 47
Email
monique.grandjean@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Eric SOLARY, MD
First Name & Middle Initial & Last Name & Degree
Elisabeth BERGER, MD
Facility Name
CHU Albert Michallon
City
Grenoble
ZIP/Postal Code
38043
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Yves CAHN, Professor
Phone
00 33 4 76 76 94 45
Email
JYCahn@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Stephane COURBY, MD
Phone
00 33 4 76 76 59 53
Email
Scourby@chu-grenoble.fr
First Name & Middle Initial & Last Name & Degree
Jean-Yves CAHN, MD
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87046
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique BORDESSOULE, Profesor
Phone
00 33 5 55 05 66 42
Email
bordessoule@unilim.fr
First Name & Middle Initial & Last Name & Degree
Dominique BORDESSOULE, Profesor
Facility Name
Hopital Paoli Calmette
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert VEY, MD
Phone
00 33 4 31 22 36 95
Email
veyn@marseille.fnclcc.fr
First Name & Middle Initial & Last Name & Degree
Norbert VEY, MD
First Name & Middle Initial & Last Name & Degree
Aude CHARBONNIER, MD
First Name & Middle Initial & Last Name & Degree
Reda BOUABDALLAH, MD
Facility Name
CHU Archet
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence LEGROS, DOCTOR
Phone
00 33 4 92 03 58 44
Email
legros@nice.fr
First Name & Middle Initial & Last Name & Degree
Laurence LEGROS, MD
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FRANCOIS DREYFUS, Profesor
Phone
00 33 1 58 41 21 20
Email
francois.dreyfus@ch.aphp.fr
First Name & Middle Initial & Last Name & Degree
Nathalie Klein, CRE
Phone
00 33 1 58 41 20 44
Email
nathalie.klein@cch.aphp.fr
First Name & Middle Initial & Last Name & Degree
François DREYFUS, Profesor
Facility Name
Centre Hospitalier Joffre
City
Perpignan
ZIP/Postal Code
66046
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Sanhes, MD
Phone
00 33 468616448
Email
laurence.sanhes@ch-perpignan.fr
First Name & Middle Initial & Last Name & Degree
Laurence Sanhes, MD
Facility Name
Centre Henry Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Centre Hospitalier Universitaire de STRASBOURG
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shanti NATARAJAN-AME, MD
Phone
00 33 3 88 12 76 70
Email
shanti.ame@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Marjorie SIDHOUM, CRA
Phone
00 33 3 88 12 81 48
Email
marjorie.sidhoum@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Shanti NATARAJAN-AME, MD
Facility Name
CHU Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Laurent, MD
Phone
00 33 5 61 77 20 78
Email
beynerauzy.o@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Guy LAURENT, MD
First Name & Middle Initial & Last Name & Degree
Odile BEYNE-RAUZY, MD
Facility Name
CHU Brabois
City
Vandoeuvre
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agnes GUERCI-BRESLER, MD
Phone
00 33 3 83 15 3281
Email
a.guerci@chu-nancy.fr
First Name & Middle Initial & Last Name & Degree
Agnes GUERCI-BRESLER, MD

12. IPD Sharing Statement

Learn more about this trial

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

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