Tailored Prednisone Reduction in Preventing Hyperglycemia in Participants With B-Cell Non-Hodgkin Lymphoma Receiving Combination Chemotherapy Treatment

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status and phase

Active, not recruiting
Phase 2

Conditions

B-Cell Non-Hodgkin Lymphoma

Treatments

Drug: Vincristine Sulfate
Drug: Cyclophosphamide
Drug: Doxorubicin Hydrochloride
Biological: Rituximab
Other: Questionnaire Administration
Other: Laboratory Biomarker Analysis
Other: Quality-of-Life Assessment
Drug: Prednisone

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03505762
P30CA012197 (U.S. NIH Grant/Contract)
CCCWFU 98317 (Other Identifier)
NCI-2018-00585 (Registry Identifier)
IRB00050108

Details and patient eligibility

About

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.

Full description

PRIMARY OBJECTIVES: 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. 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. 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. EXPLORATORY OBJECTIVES: 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: Participants are randomized to 1 of 2 arms. ARM I: Participants receive rituximab intravenously (IV), vincristine sulfate IV, doxorubicin hydrochloride IV, and cyclophosphamide IV on day 1. Participants also receive tailored prednisone dose orally (PO) once daily (QD) on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: 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. After completion of study treatment, participants are followed up to 5 years.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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 (either directly or via a legally authorized representative)

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; breastfeeding should be discontinued if the mother is treated with these agents

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

Arm I (tailored prednisone dose)
Experimental group
Description:
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.
Treatment:
Drug: Prednisone
Other: Quality-of-Life Assessment
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
Biological: Rituximab
Drug: Doxorubicin Hydrochloride
Drug: Cyclophosphamide
Drug: Vincristine Sulfate
Arm II (usual care prednisone dose)
Active Comparator group
Description:
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.
Treatment:
Drug: Prednisone
Other: Quality-of-Life Assessment
Other: Laboratory Biomarker Analysis
Other: Questionnaire Administration
Biological: Rituximab
Drug: Doxorubicin Hydrochloride
Drug: Cyclophosphamide
Drug: Vincristine Sulfate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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