Vorinostat and Low Dose Cytarabine for High Risk Myelodysplasia

Sponsor
Groupe Francophone des Myelodysplasies
Study ID
NCT00776503
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VORINOSTAT — DRUG
    vorinostat; 400mg once daily; increasing duration (7-10-14 days)

Study Details

The purpose of this study is to determine the maximum tolerated duration and schedule of oral VORINOSTAT in addition to low dose cytarabine in the treatment of Intermediate-2 and High risk myelodysplastic syndromes.

Key Dates

Start date
May 31, 2008
Status verified
Nov 2011
Primary completion
Nov 30, 2011
Completion
Nov 30, 2011

Study Design

Enrollment
52 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: B
    Cytarabine 10mg/m2 day 1-14 Vorinostat 400mg/d day 1-(7 or 10 or 14)
  • Experimental: A
    Cytarabine 10mg/m2 day 1-14 Vorinostat 400mg/d day 15-(21 or 24 or 28)

Primary Outcome Measure

To determine the Maximum tolerated dose of the association [ Time Frame: After 1 cycle of treatment ]

Related Studies