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Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Myelodysplastic Syndromes

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Trial Information

Phase I/II Study of Bortezomib and Low Dose Cytarabine in the Treatment of High-Risk Myelodysplastic Syndromes


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete Response

Principal Investigator

Francois DREYFUS, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe francaise des Myelodysplasies

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

GFM BAR-C-2005

NCT ID:

NCT00411905

Start Date:

June 2006

Completion Date:

June 2006

Related Keywords:

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

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