Study Details

Open

Testing CC-486 (Oral Azacitidine) Plus the Standard Drug Therapy in Patients 75 Years or Older With Newly Diagnosed Diffuse Large B Cell Lymphoma

This study is being done to answer the following questions: Will patients that are 75 years of age or older who were recently diagnosed with Diffuse Large B Cell Lymphoma (DLBCL) be able to take the study drug CC-486 (oral azacitidine) plus the standard chemotherapy drugs that fights cancer cells: • without significantly more side effects than patients taking the standard drug therapy alone? • have longer, shorter, or the same amount of time without the disease getting worse (progression) than patients taking the standard drug therapy alone? • live longer, live the same amount of time, or live a shorter amount of time than patients taking the standard drug therapy alone? therapy alone; have longer, shorter, or the same amount of time without the disease getting worse (progression) than patients taking the standard drug therapy alone; live longer, live the same amount of time, or live a shorter

Age & Gender

75 years ~ 99 years
Male, Female

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

You will be required to come into UNC for chemotherapy every 3 weeks. There will be 6 chemotherapy appointments in total. You will be required to take the anti-inflammatory steriod pregnesone by mouth and record it in a drug diary. If you are assigned to the treatment arm of the study, you will need to take the study drug CC-486 (oral azacitidine) by mouth and record it in a drug diary. You will be asked to fill out questionnaires about your health and well-being at different time points in the study. You will be screened for Hepatitis B and regular blood samples will be take throughout the study.

Incentives

If you are assigned to the experimental arm of the study, you or your insurance provider will not have to pay for the study drug CC-486 (oral azacitidine)

In-person visits:
8

Total length of participation:
4.5 months of therapy and 5 years of follow up

Looking for Specific Volunteers

Able to participate:

If you have been newly diagnosed with Diffuse Large B Cell Lymphoma
If you are over 75 years old
If your heart function includes a left ventricular ejection (LVEF) fraction greater or equal to 45% as measured by echocardiogram or radionuclide venticulography

Not eligible if:

Your lymphoma is present in your central nervous system (CNS involvement)
You have already received chemotherapy or the drug rituximab as a treatment for your lymphoma, or another investigational study drug
You have active inflammatory bowel disease, celiac disease, or any other gastointestinal disorder that might interfere with the drugs being absorbed or excreted from the
You have had active cardiac disease such as: symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or myocardial infarction

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger Clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

Lineberger Comprehensive Cancer Center
NC Cancer Hospital (Basnight)
UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Anne Beaven
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Aging
Cancer (Lymphoma)

IRB Number

21-3225

ClinicalTrials.gov

NCT04799275