Tailored Prednisone Reduction in Preventing Hyperglycemia in Patients with B-Cell Non-Hodgkin Lymphoma Receiving Combination Chemotherapy Treatment
- Diagnosis of B cell non-Hodgkin lymphoma confirmed by World Health Organization (WHO) criteria
- Planned treatment with R-CHOP chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3
- Life expectancy of greater than 3 months with chemotherapy
- 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
- Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
- Uncontrolled human immunodeficiency virus (HIV), CD4 count < 50
- Diagnosis of primary central nervous system (CNS) lymphoma
- Unable to receive R-CHOP chemotherapy
- History of severe (i.e. anaphylactic) allergic reactions attributed to compounds of similar chemical or biologic composition to glucocorticoids and other component of R-
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection not controlled with antibiotics, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia that cannot be rate controlled with medications, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study from this study because R-CHOP includes D Class agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with R-CHOP, breastfeeding should be discontinued if the mother is treated with these agents
I. To compare the cumulative incidence of hyperglycemia after 3 cycles of treatment between standard or tailored rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone (R-CHOP) chemotherapy.
I. To compare the cumulative incidence of hyperglycemia after 6 cycles of treatment and at 6 months post-treatment between standard or tailored R-CHOP chemotherapy.
II. To compare response rates after 6 cycles of treatment as measured by Cheson’s criteria between standard or tailored R-CHOP chemotherapy.
III. To compare cumulative rates of grade III or higher adverse events using Common Terminology Criteria for Adverse Events (CTCAE) criteria between standard or tailored R-CHOP chemotherapy from cycle 1 through cycle 6.
IV. To compare severity of prednisone related adverse events using the Patient Reported Outcome (PRO)-CTCAE form between standard or tailored R-CHOP chemotherapy from cycle 1 through cycle 6.
V. To compare health related quality of life (HRQOL) between standard or tailored R-CHOP chemotherapy at baseline, cycle 4 day 1 and after cycle 6.
I. To evaluate the alternative glucose measures of fasting blood glucose (FBG), hemoglobin A1c (HbA1c), fasting insulin and fructosamine to estimate hyperglycemia.
II. To compare health related quality of life (HRQOL) in those with and without hyperglycemia after 3 cycles, 6 cycles, and 6 months post R-CHOP chemotherapy.
III. To compare glycemic variability between the standard and tailored prednisone arms at day 1 of each cycle.
IV. To determine the ability of patients in the standard or tailored prednisone R-CHOP groups to complete all six cycles of chemotherapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive rituximab intravenously (IV), vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Patients also receive tailored prednisone dose orally (PO) once daily (QD) on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Patients also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, 6 months, and then annually for up to 5 years.
Trial Phase Phase II
Trial Type Treatment
Wake Forest University Health Sciences
- Primary ID CCCWFU 98317
- Secondary IDs NCI-2018-00585
- Clinicaltrials.gov ID NCT03505762