A Randomized Phase II Pilot of Tailored Prednisone Reduction Versus Usual Care for the Treatment of Hyperglycemia During R-CHOP Chemotherapy
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Cumulative Percentage of Patients With Hyperglycemia Patients of Standard or Tailored Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate and Prednisone (R-CHOP)
Study Overview
Brief Summary
This phase II trial studies how well tailored prednisone reduction works in preventing hyperglycemia in participants with B-cell non-Hodgkin lymphoma receiving combination chemotherapy treatment. Drugs used in chemotherapy, such as rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Reductions in prednisone dose may lower blood sugar levels.
Detailed Description
PRIMARY OBJECTIVES:
I. To compare the cumulative incidence of hyperglycemia after 3 cycles of treatment between standard or tailored R-CHOP chemotherapy
SECONDARY OBJECTIVES:
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of B cell non-Hodgkin lymphoma confirmed by World Health Organization (WHO) criteria
- •Planned treatment with R-CHOP chemotherapy
- •18 years of age or older
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 3
- •Life expectancy of greater than 3 months with chemotherapy
- •The effects of R-CHOP on the developing human fetus 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
- •Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
Exclusion Criteria
- •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 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
Arms & Interventions
Arm I (tailored prednisone dose)
Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Questionnaire Administration (Other)
Arm I (tailored prednisone dose)
Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Laboratory Biomarker Analysis (Other)
Arm II (usual care prednisone dose)
Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Laboratory Biomarker Analysis (Other)
Arm II (usual care prednisone dose)
Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Quality-of-Life Assessment (Other)
Arm II (usual care prednisone dose)
Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Questionnaire Administration (Other)
Arm I (tailored prednisone dose)
Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Vincristine Sulfate (Drug)
Arm II (usual care prednisone dose)
Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Vincristine Sulfate (Drug)
Arm I (tailored prednisone dose)
Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Rituximab (Biological)
Arm I (tailored prednisone dose)
Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Quality-of-Life Assessment (Other)
Arm II (usual care prednisone dose)
Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Prednisone (Drug)
Arm I (tailored prednisone dose)
Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Cyclophosphamide (Drug)
Arm II (usual care prednisone dose)
Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Doxorubicin Hydrochloride (Drug)
Arm II (usual care prednisone dose)
Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Rituximab (Biological)
Arm II (usual care prednisone dose)
Participants receive rituximab, vincristine sulfate doxorubicin hydrochloride, and cyclophosphamide as in Arm I. Participants also receive usual care prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Cyclophosphamide (Drug)
Arm I (tailored prednisone dose)
Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Prednisone (Drug)
Arm I (tailored prednisone dose)
Participants receive rituximab IV, vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose PO QD on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention: Doxorubicin Hydrochloride (Drug)
Outcomes
Primary Outcomes
Cumulative Percentage of Patients With Hyperglycemia Patients of Standard or Tailored Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine Sulfate and Prednisone (R-CHOP)
Time Frame: After course 3 (63 days)
Will use the Kaplan Meier method to estimate the cumulative percentage of patients with hyperglycemia, and the log-rank test to compare hyperglycemia rates by arm after 3 cycles of R-CHOP chemotherapy.
Secondary Outcomes
- Cumulative Incidence of Hyperglycemia of Standard or Tailored R-CHOP(from baseline through 6 cycles (126 days) and at 6 months after completion of chemotherapy)
- Response Rates of Standard or Tailored R-CHOP as Measured by Cheson's Criteria(After course 6 (126 days))
- Rates of Grade III or Higher Adverse Events Using Common Terminology Criteria for Adverse Events (CTCAE) Criteria From Standard or Tailored R-CHOP(Up to 6 months (up to 400 days from start of treatment))
- Severity of Prednisone Related Adverse Events Using the Patient Reported Outcome (PRO)-CTCAE(Up to course 6 (126 days))
- Health Related Quality of Life (HRQOL) Scores(Day 1 of cycles 1, 4, 6, and 6 months post treatment (up to 400 days from start of treatment))