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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
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
  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:


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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411905

Locations
France
CHU Angers
Angers, France, 43033
Hopital Avicenne
Bobigny, France, 93009
Institut Bergonie
Bordeaux, France, 33076
CHU de Caen
Caen, France, 14033
CHU Dijon
Dijon, France, 21000
CHU Albert Michallon
Grenoble, France, 38043
CHU de Limoges
Limoges, France, 87046
Hopital Paoli Calmette
Marseille, France, 13273
CHU Archet
Nice, France, 06202
Hopital Cochin
Paris, France, 75014
Centre Hospitalier Joffre
Perpignan, France, 66046
Centre Henry Becquerel
Rouen, France, 76038
Centre Hospitalier Universitaire de STRASBOURG
Strasbourg, France, 67098
CHU Purpan
Toulouse, France, 31059
CHU Brabois
Vandoeuvre, France, 54511
Sponsors and Collaborators
Groupe Francophone des Myelodysplasies
Investigators
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 
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:
Syndrome
Myelodysplastic Syndromes
Preleukemia
Disease
Pathologic Processes
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms
Bortezomib
Cytarabine
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 02, 2016