Blinded Cross-over Bioequivalence Trial of Luitpold Azacitidine Versus Vidaza® in Patients With Myelodysplastic Syndrome, Myelofibrosis, Chronic Myeloid Leukemia or Chronic Lymphocytic Leukemia
- Signed informed consent obtained prior to initiation of any study-specific
- Patients with one of the following - myelodysplastic syndrome of the following
French-American- British (FAB) subtypes: refractory anemia (RA), RA with ringed
sideroblasts (if accompanied by neutropenia, or thrombocytopenia, or requiring
transfusion), RA with excess of blasts (RAEB), RAEB in transformation (RAEB-T), or
chronic myelomonocytic leukemia (CMMoL); myelofibrosis; chronic myeloid leukemia; or
chronic lymphocytic leukemia who's physician feels should receive azacitidine.
- Male or female patients aged at least 18 years.
- ECOG Performance Status 0-2.
- Life expectancy > or = to 3 months.
- Adequate organ function, including the following: Hepatic - Total bilirubin < or = to
1.5 x the upper limit of normal (ULN), aspartate transaminases (AST) and alanine
transaminases (ALT) < or = to 2 x ULN and Renal - Serum creatinine < or = to 1.5 x
- Female patients of child-bearing potential must have a negative pregnancy test and
must be using at least one form of contraception as approved by the Investigator for
4 weeks prior to the study and 4 months after the last dose of azacitidine.
- Male patients must use a form of barrier contraception approved by the investigator
during the study and for 4 months after the last dose of azacitidine.
- Hypersensitivity to azacitidine or mannitol.
- Anticipated need for RBC or platelet transfusion 2 days prior to or up to 2 days
after treatment initiation.
- Chemotherapy (excluding previous azacitidine treatment) or radiotherapy within 4
weeks of randomization (6 weeks for nitrosoureas or mitomycin C).
- Significant electrophysical abnormalities in pre-trial EKG.
- Present history of locally advanced or metastatic malignant disease or leukemia.
- Use of recreational drugs or history of drug addiction, within the prior 6 months.
- Known history of a positive hepatitis screen, including hepatitis B surface antigens
or HCV antibodies.
- Known history of HIV or syphilis.
- History of clinically significant adverse events due to chemotherapy, radiotherapy or
- Presence of an advanced malignant hepatic tumor.
- Presence of an ongoing or active infection, symptomatic congestive heart failure,
unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia,
uncontrolled thrombotic or hemorrhagic disorder, or any other serious uncontrolled
- Presence of any significant central nervous system or psychiatric disorder(s) that
would hamper the patients compliance.
- Treatment with any other investigational agent, or participation in another clinical
trial within 28 days prior to study entry.
- Pregnant or breast-feeding patients or any patient with childbearing potential not
using adequate contraception.