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

80 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Prednisone for treating non-Hodgkin's lymphoma?

Research shows that Prednisone, when used in combination with other drugs, has been effective in treating non-Hodgkin's lymphoma, with studies reporting complete and partial remission rates. For example, a study using a combination therapy including Prednisone reported a 55% overall response rate in patients with relapsing or refractory non-Hodgkin's lymphoma. ^{1 2 3 4 5}

Is prednisone generally safe for humans?

Prednisone has been used for over 60 years and is generally considered safe when used in low doses for conditions like rheumatoid arthritis. However, it can have side effects such as reduced bone formation, and in some cases, it may affect white blood cell counts and organ weights. It is important to discuss potential risks with a healthcare provider. ^{6 7 8 9 10}

How is the drug Prednisone unique in treating non-Hodgkin's lymphoma?

Prednisone is unique in treating non-Hodgkin's lymphoma because it is often used in combination with other drugs like mitoxantrone, etoposide, and cytarabine in the ENAP regimen, which has shown effectiveness in both first-line and salvage therapy for high-grade NHL. This combination therapy is partly non-cross resistant with CHOP chemotherapy, offering an alternative for patients who have relapsed or are refractory to standard treatments. ^{4 5 11 12 13}

What is the purpose of this trial?

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.

Research Team

Rakhee Vaidya

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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 am scheduled for R-CHOP chemotherapy treatment.

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Moderate versus intensive chemotherapy of prognostically favorable non-Hodgkin's lymphoma: a progress report. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Lomustine, etoposide, methotrexate and prednisone (LEMP) therapy for relapsed and refractory non-Hodgkin's lymphoma. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Moderate versus aggressive chemotherapy of nodular lymphocytic poorly differentiated lymphoma. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

Prednimustine in refractory non-Hodgkin's lymphoma: a phase II study of the Northern California Oncology Group. [2018]

5. England 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. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of low-dose prednisone on bone metabolism. [2015]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Deflazacort. A review of its pharmacological properties and therapeutic efficacy. [2018]

8. England pubmed.ncbi.nlm.nih.gov

In vitro immunosuppressive potency of deflazacort, a new bone-sparing corticosteroid on T lymphocytes, NK and K cells. [2019]

9. England pubmed.ncbi.nlm.nih.gov

The current relevance and use of prednisone in rheumatoid arthritis. [2015]

10. Japan pubmed.ncbi.nlm.nih.gov

Prednisolone (Veterinary Medicinal Products). [2020]

11. Germany pubmed.ncbi.nlm.nih.gov

Value of prednimustine in treating non Hodgkin's lymphomas of favourable histological type. [2015]

12. China pubmed.ncbi.nlm.nih.gov

[Efficacy of DICE (dexamethasone, etoposide, ifosfamide, and cisplatin) regimen on recurrent and refractory non-Hodgkin's lymphoma]. [2015]

13. Sweden pubmed.ncbi.nlm.nih.gov

Clinical trial of prednimustine, Leo-1031 (NSC-134087), in patients with non-Hodgkin lymphomata and chronic lymphocytic leukaemia previously treated with steroids and alkylating agents. [2019]