New York, New York 10065

  • 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


Overall Status:

Recruiting


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


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:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Mask


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

46


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Rebecca Elstrom, MD
Principal Investigator
Weill Medical College of Cornell University
Primary Contact:Rebecca Elstrom, MD
212-746-2063
ree2001@med.cornell.edu

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
Name:rituximab
Description:375 mg/m2 on Day 8 of each of 6 cycles
Arm Name:All patients
Intervention Type:Drug
Name:cyclophosphamide
Description:750 mg/m2 on Day 8 of each of 6 cycles
Arm Name:All patients
Intervention Type:Drug
Name:vincristine
Description:1.4 mg/m2 on Day 8 of each of 6 cycles
Arm Name:All patients
Intervention Type:Drug
Name:doxorubicin
Description:50 mg/m2 on Day 8 of each of 6 cycles
Arm Name:All patients
Intervention Type:Drug
Name:prednisone
Description:100 mg PO days 8-12 of each of 6 cycles
Arm Name:All patients
Intervention Type:Drug
Name:azacytidine
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: ClinicalTrials.gov

Date Processed: February 02, 2023

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


If you would like to be contacted by the clinical trial representative please fill out the form below.