New York, New York 10065

  • 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 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:




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

Overall Status:


Study Phase:

Phase 1/Phase 2



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Weill Medical College of Cornell University

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Intervention Model: Single Group Assignment, Mask

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Rebecca Elstrom, MD
Principal Investigator
Weill Medical College of Cornell University
Primary Contact:Rebecca Elstrom, MD

Study Dates

Start Date:January 2010
Primary Completion Date:January 2013
Primary Completion Type:Anticipated
Verification Date:March 2011
Last Changed Date:March 8, 2011
First Received Date:October 29, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure:The primary endpoint for the phase I portion of the study is to determine the maximum tolerated dose and toxicity of azacytidine when given in combination with a standard dose (q 21 day) regimen of R-CHOP in patients with DLBCL.
Time Frame:6 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:The primary endpoint for the phase II portion of the study will be progression-free survival(PFS), as measured from the start of the treatment to the date of either documentation of disease progression or death.
Time Frame:36 months
Safety Issues:False

Study Interventions

Intervention Type:Biological
Description:375 mg/m2 on Day 8 of each of 6 cycles
Arm Name:All patients
Intervention Type:Drug
Description:750 mg/m2 on Day 8 of each of 6 cycles
Arm Name:All patients
Intervention Type:Drug
Description:1.4 mg/m2 on Day 8 of each of 6 cycles
Arm Name:All patients
Intervention Type:Drug
Description:50 mg/m2 on Day 8 of each of 6 cycles
Arm Name:All patients
Intervention Type:Drug
Description:100 mg PO days 8-12 of each of 6 cycles
Arm Name:All patients
Intervention Type:Drug
Description:Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5
Arm Name:All patients

Study Arms

Study Arm Type:Experimental
Arm Name:All patients
Description:subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Weill Medical College of Cornell University
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Celgene Corporation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source:

Date Processed: February 02, 2023

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