Phase I/II Trial of R-CHOP + Azacytidine in Diffuse Large B Cell Lymphoma

Therapuetic Areas:Oncology
Age Range:18 - Any
Start Date:January 2010
Contact:Rebecca Elstrom, MD

Use our guide to learn which trials are right for you!

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.

Inclusion Criteria:

- 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
azacitidine treatment.

- 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

Exclusion Criteria:

- 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.
We found this trial at
New York, New York 10021
New York, NY
Click here to add this to my saved trials