Status:
COMPLETED
Vorinostat in Combination With Azacitidine in Patients With Newly-Diagnosed Acute Myelogenous Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Celgene Corporation
Conditions:
Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
The Study Drugs: Azacitidine is designed to block certain genes in cancer cells whose job is to stop the function of the tumor-fighting genes. By blocking the "bad" genes, the tumor-fighting genes ma...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed AML or MDS (Intermediate 1 or higher risk)
- Patient must have at least one of the following: a. Creatinine \>/= 2 mg/dL; b. total Bilirubin \>/= 2 mg/dL; c.ECOG Performance Status equal to 3 or 4; and d. is ineligible for participation on a protocol of higher priority
- Patients must provide written informed consent.
- Patients must be age \> 18 years due to lack of safety information with these agents in children.
- Patient agrees to: 1) Use 2 adequate methods of contraception to prevent pregnancy (either 2 barrier methods or a barrier method plus a hormonal contraceptive method) or 2) abstain from heterosexual activity throughout the study starting with Visit 1.
- Female patients of childbearing potential should have a negative pregnancy test (serum) within 72 hrs. of study enrollment.
Exclusion
- Patients must not have the favorable cytogenetic abnormalities of inv (16), t (16;16), t (8;21), or t (15;17).
- Patients receiving any anti-leukemic therapy with the exception of Hydroxyurea prior to study enrollment. Prior growth factor therapy is acceptable. Hydroxyurea could be used at the discretion of the treating physician. A single or a two day dose of cytarabine (up to 3 g/m\^2) for emergency use is allowed as prior therapy.
- Patient has a prior history of treatment with HDAC inhibitors. Patients who have received valproic acid (VPA) for the treatment of seizures may be enrolled on this study, but must not have received VPA within 30 days of study enrollment.
- Patient is unable to take and/or tolerate oral medications on a continuous basis, examples include patients on a ventilator, or have altered mental status that precludes safe oral route of administration.
- Patient has active hepatitis A, B, or C infection.
- Patient is pregnant or breast-feeding.
- Patient has a known allergy or hypersensitivity to any component of vorinostat or azacitidine.
- History of any psychiatric condition that might impair the patient's ability to understand or to comply with the requirements of the study or to provide informed consent.
Key Trial Info
Start Date :
September 8 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2017
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00948064
Start Date
September 8 2009
End Date
August 3 2017
Last Update
February 24 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030