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Corticosteroid

Prednisone Reduction for Non-Hodgkin's Lymphoma

Phase 2
Waitlist Available
Led By Rakhee Vaidya
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Planned treatment with R-CHOP chemotherapy
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months
Awards & highlights

Study Summary

This trial looks at how well reducing the dose of prednisone helps to prevent high blood sugar levels in people with B-cell non-Hodgkin lymphoma who are receiving combination chemotherapy.

Who is the study for?
This trial is for adults with B-cell non-Hodgkin lymphoma who can consent to treatment, have a life expectancy over 3 months with chemo, and are not pregnant or breastfeeding. They must be able to receive R-CHOP chemotherapy and use birth control during the study. People with primary CNS lymphoma, severe allergies to similar drugs, uncontrolled HIV (CD4 count < 50), or other serious illnesses that could limit participation are excluded.Check my eligibility
What is being tested?
The trial tests if adjusting the dose of prednisone can prevent high blood sugar in patients getting R-CHOP chemo for B-cell non-Hodgkin lymphoma. It involves drugs like rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate alongside prednisone dosage adjustments based on blood sugar levels.See study design
What are the potential side effects?
Possible side effects include reactions related to each drug: immune system suppression from rituximab; hair loss and nausea from doxorubicin; nerve damage from vincristine; mouth sores and low white cell counts from cyclophosphamide; weight gain and mood changes from prednisone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for R-CHOP chemotherapy treatment.
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I can understand and am willing to sign the consent form approved by the review board.
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My doctor expects me to live more than 3 months with chemotherapy.
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My diagnosis is B cell non-Hodgkin lymphoma, confirmed by official standards.
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I can care for myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative incidence of hyperglycemia of standard or tailored rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate and prednisone (R-CHOP)
Secondary outcome measures
Cumulative incidence of hyperglycemia of standard or tailored R-CHOP
Health related quality of life (HRQOL) scores
Rates of grade III or higher adverse events using Common Terminology Criteria for Adverse Events (CTCAE) criteria from standard or tailored R-CHOP
+2 more
Other outcome measures
Fasting blood glucose (FBG) levels
Fasting insulin
Fructosamine levels
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (tailored prednisone dose)Experimental Treatment8 Interventions
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.
Group II: Arm II (usual care prednisone dose)Active Control8 Interventions
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Prednisone
2014
Completed Phase 4
~2370
Rituximab
1999
Completed Phase 4
~1880
Vincristine Sulfate
2005
Completed Phase 3
~10110
Cyclophosphamide
1995
Completed Phase 3
~3780

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,103 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,073 Total Patients Enrolled
Rakhee VaidyaPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

Prednisone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT03505762 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Arm I (tailored prednisone dose), Arm II (usual care prednisone dose)
Non-Hodgkin's Lymphoma Clinical Trial 2023: Prednisone Highlights & Side Effects. Trial Name: NCT03505762 — Phase 2
Prednisone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03505762 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the risk profile for Prednisone?

"While there is some evidence pointing to the safety of Prednisone, it only received a score of 2 because this is a Phase 2 trial and no data exists yet proving its efficacy."

Answered by AI

Are there any other research papers that mention Prednisone?

"As of this moment, there are 1561 clinical trials involving Prednisone that are currently recruiting patients. Of these studies, 338 have reached Phase 3 testing. Although a large portion of thesePrednisone studies originate from Bethesda, Maryland, there 54738 total locations running such trials."

Answered by AI

Is it possible to sign up for this clinical trial at the moment?

"The information available on clinicaltrials.gov verifies that this study is still enrolling patients. This trial was originally posted on July 19th, 2018 and the most recent update was October 6th, 2022. The research team is looking for a total of 80 participants at 1 site."

Answered by AI

For what medical reasons is Prednisone most commonly prescribed?

"Prednisone is not only useful in the treatment of pheochromocytomas, but also for other health concerns like ulcerative colitis, varicella-zoster virus acute retinal necrosis, and multiple myeloma."

Answered by AI

What is the target number of participants for this research project?

"That is correct. According to the latest update on clinicaltrials.gov, this study was posted on 7/19/2018 and is currently looking for 80 participants across 1 site."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Tailored Prednisone Reduction in Preventing Hyperglycemia in Participants With B-Cell Non-Hodgkin Lymphoma Receiving Combination Chemotherapy Treatment
2018. "Tailored Prednisone Reduction in Preventing Hyperglycemia in Participants With B-Cell Non-Hodgkin Lymphoma Receiving Combination Chemotherapy Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03505762.
~12 spots leftby Apr 2025
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