Overview

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

Status:
Completed
Trial end date:
2017-08-03
Target enrollment:
0
Participant gender:
All
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 will also be studied.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Celgene Corporation
Merck Sharp & Dohme Corp.
Treatments:
Azacitidine
Vorinostat
Criteria
Inclusion Criteria:

1. Patients with newly diagnosed AML or MDS (Intermediate 1 or higher risk)

2. 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

3. Patients must provide written informed consent.

4. Patients must be age > 18 years due to lack of safety information with these agents in
children.

5. 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.

6. Female patients of childbearing potential should have a negative pregnancy test
(serum) within 72 hrs. of study enrollment.

Exclusion Criteria:

1. Patients must not have the favorable cytogenetic abnormalities of inv (16), t (16;16),
t (8;21), or t (15;17).

2. 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.

3. 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.

4. 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.

5. Patient has active hepatitis A, B, or C infection.

6. Patient is pregnant or breast-feeding.

7. Patient has a known allergy or hypersensitivity to any component of vorinostat or
azacitidine.

8. 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.