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

Purpose:

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.

Criteria:

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 greater. - 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 document. - 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 form. - 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.

Study is Available At:

Original ID:

0907010513

NCT ID:

NCT01004991

Secondary ID:

Study Acronym:

Brief Title:

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

Official Title:

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

ClinicalTrials.gov Link:

http://clinicaltrials.gov/show/NCT01004991

Overall Status:

Recruiting

Study Phase:

Phase 1/Phase 2

Genders:

Both

Minimum Age:

18 Years

Maximum Age:

N/A

Study Source:

Weill Medical College of Cornell University

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Mask

Number of Arms:

1

Number of Groups:

0

Total Enrollment:

46

Enrollment Type:

Anticipated

Data Source: ClinicalTrials.gov

Date Processed: February 02, 2023

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