Prednisone Reduction for Non-Hodgkin's Lymphoma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Wake Forest University Health Sciences

Must be taking: R-CHOP chemotherapy

Disqualifiers: Uncontrolled HIV, CNS lymphoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether reducing prednisone (a corticosteroid) during chemotherapy can prevent high blood sugar in people with B-cell non-Hodgkin lymphoma, a type of blood cancer. Participants will receive either a tailored lower dose of prednisone or the usual dose, alongside other standard chemotherapy drugs. The goal is to determine if the lower dose effectively controls blood sugar without compromising cancer treatment. Individuals with a confirmed diagnosis of B-cell non-Hodgkin lymphoma who are set to start R-CHOP chemotherapy may be suitable for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that reducing prednisone can be safe for patients with non-Hodgkin lymphoma. One study found that lowering the dose did not compromise disease control in similar patients. This suggests that carefully reducing prednisone might be well-tolerated.

Prednisone, often used in cancer treatments, is generally safe but can cause high blood sugar. The trial aims to manage this side effect by reducing prednisone. Using less prednisone may lead to fewer cases of high blood sugar while maintaining treatment effectiveness.

Overall, these findings suggest that adjusting prednisone doses is a safe approach for patients, without increasing risks or affecting treatment success. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about this trial because it explores the potential benefits of tailoring prednisone doses for patients with Non-Hodgkin's Lymphoma. Unlike the standard approach where a usual care dose of prednisone is administered, this trial investigates if adjusting the prednisone dose based on individual patient needs can enhance treatment outcomes. The goal is to maintain effectiveness while possibly reducing side effects, which could be a significant improvement over the conventional one-size-fits-all method. By refining the dosing strategy, researchers hope to optimize patient care and improve quality of life during treatment.

What evidence suggests that this trial's treatments could be effective for non-Hodgkin's lymphoma?

Research has shown that combining prednisone with chemotherapy drugs like rituximab, cyclophosphamide, doxorubicin, and vincristine effectively treats non-Hodgkin's lymphoma. One study found that 55% of patients with relapsing or hard-to-treat non-Hodgkin's lymphoma responded well to this combination therapy. These drugs kill cancer cells or stop them from growing and spreading. In this trial, participants will receive either a tailored prednisone dose or a usual care prednisone dose alongside these chemotherapy drugs. Adjusting the prednisone dose might also help control blood sugar levels, a common side effect. Overall, this drug combination has shown promising results in improving patient outcomes. ^{2 6 7 8 9}

Who Is on the Research Team?

Rakhee Vaidya

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can understand and am willing to sign the consent form approved by the review board.

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

I am scheduled for R-CHOP chemotherapy treatment.

Exclusion Criteria

My HIV is not under control, and my CD4 count is below 50.

Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with these agents

You have had a serious allergic reaction to drugs similar to glucocorticoids.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive R-CHOP chemotherapy every 21 days for up to 6 cycles

18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are followed up to 5 years to monitor long-term outcomes

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Prednisone

Trial Overview 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.

How Is the Trial Designed?

Group I: Arm I (tailored prednisone dose) Experimental Treatment 8 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 Control 8 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.

Prednisone is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Prednisone for:

• Allergic reactions
• Asthma
• Blood disorders
• Cancer
• Eye problems
• Immune system disorders
• Inflammatory conditions
• Multiple sclerosis
• Organ transplantation
• Rheumatoid arthritis
• Skin conditions

Approved in European Union as Prednisone for:

• Allergic reactions
• Asthma
• Blood disorders
• Cancer
• Eye problems
• Immune system disorders
• Inflammatory conditions
• Multiple sclerosis
• Organ transplantation
• Rheumatoid arthritis
• Skin conditions

Approved in Canada as Prednisone for:

• Allergic reactions
• Asthma
• Blood disorders
• Cancer
• Eye problems
• Immune system disorders
• Inflammatory conditions
• Multiple sclerosis
• Organ transplantation
• Rheumatoid arthritis
• Skin conditions

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 29 patients with relapsing or refractory high-grade malignant non-Hodgkin lymphoma (NHL), the ENAP chemotherapy regimen showed a promising overall response rate of 55%.

When ENAP was used as a first-line treatment in 45 previously untreated NHL patients, it resulted in a complete remission rate of 27% and a partial remission rate of 73% after just one course, indicating its effectiveness as both a first-line and salvage treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mitoxantrone, etoposide, cytarabine and prednisone as salvage therapy for refractory non-Hodgkin lymphoma (NHL) and alternated with CHOP in previously untreated patients with NHL. Merk, K., Ideström, K., Johansson, B., et al.[2019]

In a study of 22 patients with non-Hodgkin's lymphoma, the LEMP regimen (oral lomustine, i.v. etoposide, methotrexate, and prednisone) resulted in 5 complete remissions and 12 partial remissions, demonstrating its efficacy in patients who had previously undergone chemotherapy.

The treatment was well tolerated with minimal toxicity, showing no alopecia or cardiotoxicity, and no treatment-related deaths, suggesting it could be a safer option for patients unable to handle more intensive therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lomustine, etoposide, methotrexate and prednisone (LEMP) therapy for relapsed and refractory non-Hodgkin's lymphoma. Dorigo, A., Mansberg, R., Kwan, YL.[2019]

Prednisone has been effectively used for over 60 years to treat inflammatory conditions like rheumatoid arthritis, and recent clinical trials have shifted its use towards long-term low-dose regimens.

Current research is focusing on the safety and effectiveness of these low-dose treatments, including insights from the 2nd Circadian Administration of Prednisone trial, which explores the benefits of modified-release formulations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The current relevance and use of prednisone in rheumatoid arthritis. Krasselt, M., Baerwald, C.[2015]

Citations

1. withpower.com withpower.com/trial/phase-3-hyperglycemia-6-2018-48d26

Prednisone Reduction for Non-Hodgkin's Lymphoma For example, a study using a combination therapy including Prednisone reported a 55% overall response rate in patients with relapsing or refractory non-Hodgkin ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10884502/

The prednisone dosage in the CHOP chemotherapy ... Based on this study, a prednisone dose of 100 mg/day for five days should be considered the standard dose.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10628567/

Guideline Concordance of Treatment and Outcomes ... Guideline concordance of treatment and outcomes among adult non-Hodgkin lymphoma patients in Sub-Saharan Africa: a multinational, population-based cohort.

4. ascopubs.org ascopubs.org/doi/10.1200/GO.21.00265

Clinical Outcomes of Patients With B-Cell Non-Hodgkin ... The median overall survival from first relapse for patients with DLBCL was 6.6 years, with lower risk of death for those diagnosed at age < 65 years.

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(13)60313-X/fulltext

Rituximab plus cyclophosphamide, doxorubicin, vincristine ... Dose intensification with a combination of cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) every 2 weeks improves outcomes in patients ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03505762?term=AREA%5BConditionSearch%5D(%22B-Cell%20Neoplasm%22)%20AND%20AREA%5BInterventionSearch%5D(%22Prednisone%22)&rank=8

Study Details | Tailored Prednisone Reduction in ... A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10972460/

Reduced Corticosteroid Exposure Is Safe and Does Not ... Reduced corticosteroid exposure is safe and does not reduce disease control among Hodgkin lymphoma patients treated with escalated BEACOPP (eBEACOPP).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3360906/

Tailored Therapy in an Unselected Population of 91 Elderly ... Ninety-one elderly patients with diffuse large B-cell lymphoma were given tailored treatment based on the results of a comprehensive geriatric assessment.

9. haematologica.org haematologica.org/article/view/haematol.2021.278719

Prephase rituximab/prednisone therapy and aging-related, ... With a median follow-up of 4.4 years, both 5-year progression-free survival and overall survival were at 81% (95% confidence interval: 69-96).