- Patients must have histologically confirmed DLBCL with characteristic
immunophenotypic profiles. Tumor tissue must be confirmed to express the CD20 antigen
by flow cytometry or immunohistochemistry.
- Patients must have at least one site of measurable disease, 1.5 cm in diameter or
- Patient has not had any previous treatment.
- Stage II (not appropriate for abbreviated chemoimmunotherapy and radiotherapy), III
or IV disease
- Able to adhere to the study visit schedule and other protocol requirements.
- Patients must have laboratory test results within these ranges:
- Absolute neutrophil count > = 1500/mm³
- Platelet count > = 75,000/mm³
- Serum creatinine < = 1.5X upper limit of normal (ULN)
- Total bilirubin < = 1.5X ULN. Higher levels are acceptable if these can be
attributed to active hemolysis or ineffective erythropoiesis.
- AST (SGOT) and ALT (SGPT) < = 2 x ULN
- Disease free of prior malignancies for > = 5 years with exception of currently
treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of
the cervix or breast.
- Women of childbearing potential must have a negative serum pregnancy test prior to
- Women of childbearing potential should be advised to avoid becoming pregnant and men
should be advised to not father a child while receiving treatment with azacitidine.
The effects of azacytidine on the developing human fetus at the recommended
therapeutic dose are unknown. For this reason, women of child-bearing potential and
men must agree to use adequate contraception (hormonal or barrier method of birth
control; abstinence) prior to study entry and for the duration of study
participation. Should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately.
- Age >18 years.
- Ability to understand and the willingness to sign a written informed consent
- ECOG performance status of 0-2
- Patients must not have any serious medical condition, laboratory abnormality,or
psychiatric illness that would prevent the subject from signing the informed consent
- Patients must not have any condition, including the presence of laboratory
abnormalities, which places the subject at unacceptable risk if he/she were to
participate in the study or confounds the ability to interpret data from the study.
- Use of any other experimental drug or therapy within 28 days of baseline.
- Concurrent use of other anti-cancer agents or treatments.
- Known positive for HIV or infectious hepatitis B.
- Known central nervous system involvement by lymphoma.
- Known or suspected hypersensitivity to azacitidine or mannitol.
- Patients must not have advanced malignant hepatic tumors.
- Pregnant and lactating women are excluded from the study because the risks to an
unborn fetus or potential risks in nursing infants are unknown.