Home » Clinical Trials » Lymphoma, B-Cell
Clinical Trial Details
Research Study Summary
A Phase 1/Phase 2 clinical study for patients with Diffuse Large B Cell Lymphoma
Research Study Title
Phase I/II Trial of Azacytidine + R-CHOP in Diffuse Large B-Cell Lymphoma
This is a phase I/II open label, multi-center study of azacytidine in combination with
standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at
escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on
day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion
will then evaluate efficacy of the combination at the established MTD.
To Learn more
Both Male and Female
Both Male and Female ages 18 Years and up
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.
Site Locations (1)
||Weill Cornell Medical College
Rebecca Elstrom, MD
Rebecca Elstrom, MD
NCT ID: NCT01004991
Date Last Changed: March 8, 2011
DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials. Some study summaries have been edited for clarity purposes to make them easier to understand. View more study details here.