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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 because the information has not been verified recently.
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

December 14, 2006
March 9, 2007
June 2006
Not Provided
  • Complete Response
  • Partial Response
Same as current
Complete list of historical versions of study NCT00411905 on ClinicalTrials.gov Archive Site
Hematological Improvement
Same as current
Not Provided
Not Provided
 
Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes
Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes

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.

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

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelodysplastic Syndromes
Drug: Bortezomib
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
39
June 2006
Not Provided

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
Both
18 Years and older
No
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
France
 
NCT00411905
GFM BAR-C-2005
No
Not Provided
Groupe Francophone des Myelodysplasies
Not Provided
Principal Investigator: Francois DREYFUS, MD PhD Groupe francaise des Myelodysplasies
Groupe Francophone des Myelodysplasies
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP