Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00948064
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Vorinostat — DRUG
    200 mg by mouth three (3) times per day with food for 5 days (Days 1 - 5)
  • Azacitidine — DRUG
    75 mg/m\^2/day given intravenously over 15 - 30 minutes daily for 5 days (Days 1 - 5)

Study Details

The goal of this clinical research study is to learn if the combination of azacitidine and vorinostat can help to control AML or MDS better than azacitidine alone. The safety of this drug combination will also be studied.

Key Dates

Start date
Sep 8, 2009
Status verified
Feb 2020
Primary completion
Apr 30, 2015
Completion
Aug 3, 2017

Study Design

Enrollment
110 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Vorinostat with Azacitidine
    ARM A: Azacitidine 75 mg/m\^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
  • Experimental: Azacitidine
    ARM B: Azacitidine 75 mg/m\^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.

Primary Outcome Measure

Survival at Day 60 [ Time Frame: Phase I, Baseline to 60 days following first treatment. ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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