New Cancer Treatment for Non-Hodgkin's Lymphoma

Recruiting at 3 trial locations

Overseen By Raul Ribeiro, MD

Age: < 65

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: St. Jude Children's Research Hospital

Disqualifiers: HIV positive, Pregnant, Lactating, 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

Compensation: Varies

Number of Visits: Unknown

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new treatments for children with specific types of non-Hodgkin's lymphoma, a cancer affecting the immune system. The researchers aim to improve outcomes by studying tumor biology and the long-term effects of treatment. Participants will receive treatment plans tailored to their cancer stage and characteristics. Children under 22 with a diagnosis of mature B-cell lymphoma, who have not started treatment, may qualify for this study. The trial includes treatments such as COP (Cyclophosphamide, Oncovin, and Prednisone). As a Phase 2 and Phase 3 trial, it evaluates the treatment's effectiveness in a smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that participants have not been previously treated, except for limited use of steroids, one intrathecal chemotherapy treatment, or emergency radiation.

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

Research has shown that the treatments in this trial have varying safety levels based on past studies. For the COP treatment, studies suggest a lower risk of heart problems in patients with non-Hodgkin's lymphoma. One study found that cyclophosphamide, a main drug in COP, is generally well-tolerated.

COPAD, another treatment in the trial, has been linked to high survival rates in children with a specific type of non-Hodgkin lymphoma, indicating its effectiveness and manageable safety concerns when used carefully.

For COPADM8, safety data supports its use for certain B-cell lymphomas, indicating an acceptable safety level.

COPD M3 treatments have been associated with breathing issues, especially when used with rituximab, a common drug for lymphoma, necessitating close monitoring of patients during treatment.

Finally, recent studies have shown that the CYVE regimen offers a good balance between safety and effectiveness for treating non-Hodgkin's lymphoma, suggesting that CYVE is generally well-tolerated.

These findings indicate that while each treatment has specific risks, they are generally manageable, making them viable options in clinical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for Non-Hodgkin's Lymphoma because they offer new combinations and sequences of chemotherapy drugs tailored to specific patient needs. Unlike standard treatments, which often follow a one-size-fits-all approach, this trial explores different regimens based on disease stage and involvement, like COPAD M3 and COPADM8 for induction therapy that could potentially enhance effectiveness by targeting the cancer more precisely. Moreover, the inclusion of maintenance therapy in some regimens aims to sustain remission and reduce relapse rates, offering hope for improved patient outcomes.

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

Research has shown that the treatments used in this trial have potential for treating Non-Hodgkin's Lymphoma (NHL). Participants in Group A will receive COPAD, which has demonstrated positive results, with nearly 100% of certain groups not experiencing major issues for a period of time. Group B will include the COP, COPD M3, and CYM treatments. Past studies have shown that COP achieved an 81% rate of complete response, meaning many patients saw their cancer disappear, and a 52% survival rate over five years. CYM has shown a promising rate of 75% for patients not experiencing major issues over time in similar studies. Group C will receive COP, COPADM8, and CYVE treatments. COPADM8 demonstrated an 83% overall response compared to other treatments, and CYVE reported a 79% rate of patients not experiencing major issues over four years, indicating strong potential for effectiveness. These findings suggest these treatments can improve outcomes for those with NHL. ^{4 6 7 8 9}

Who Is on the Research Team?

Raul C. Ribeiro, MD

Principal Investigator

St. Jude Children's Research Hospital

Are You a Good Fit for This Trial?

This trial is for children and young adults under 22 years old with a diagnosis of mature B-cell lymphoma, such as Burkitt lymphoma or diffuse large B-cell lymphoma. They must be previously untreated or have had minimal treatment. Those with hepatitis B can participate but won't receive rituximab; HIV-positive patients are excluded from the therapy part but can join biology studies.

Inclusion Criteria

I have been diagnosed with a specific type of lymphoma (like Burkitt or large B-cell).

I have not received any treatment for my condition, except possibly a short course of steroids, one spinal chemotherapy session, or emergency radiation.

I was diagnosed before turning 22 years old.

Exclusion Criteria

Participants from collaborating sites participating in therapeutic and biological objectives must not meet the following criteria:

Participants known to be HIV positive (HIV participants are eligible for biology studies only).

Participants who are pregnant or lactating.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Phase

Participants receive COP as a pre-phase treatment

2 weeks

Induction

Participants receive COPAD M3 or COPADM8 cycles depending on group allocation

4-8 weeks

Consolidation

Participants receive CYM or CYVE cycles depending on group allocation

4 weeks

Maintenance

Participants in Group C receive maintenance therapy

Variable

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

What Are the Treatments Tested in This Trial?

Interventions

• COP
• COPAD
• COPADM8
• COPD M3
• CYM
• CYVE

Trial Overview The study tests modified treatments based on the LMB-96 regimen for various types of mature B-cell lymphomas in children. It's a phase III trial focusing on improving outcomes by studying tumor biology and long-term effects of these therapies.

How Is the Trial Designed?

Group I: Group C Experimental Treatment 1 Intervention

Any CNS involvement and/or bone marrow involvement ≥ 25% blasts. For CNS involvement one or more of the following applies: 1. Any L3 blasts in CSF 2. Cranial nerve palsy (if not explained by extracranial tumor) 3. Clinical spinal cord compression 4. Isolated intracerebral mass 5. Parameningeal extension: cranial and/or spinal Group C will include the intervention COP, COPADM8, CYVE as follows: Pre-Phase: COP Induction: COPADM8 cycle 1 Induction: COPADM8 Cycle 2 Consolidation: CYVE x 2 cycles and Maintenance

Group II: Group B Experimental Treatment 1 Intervention

All cases not eligible for Group A or Group C. (Murphy Stage III and non-CNS Stage IV) Group B will include the intervention COP, COPD M3, CYM as follows: Pre-Phase: COP Induction: COPAD M3 x 2 cycles Consolidation: CYM x 2 cycles.

Group III: Group A Experimental Treatment 1 Intervention

Completely resected stage I or completely resected abdominal stage II lesions. Group A will include: COPAD x 2 cycles.

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

Approved in United States as COP for:

• Non-Hodgkin lymphoma
• Hodgkin lymphoma

Approved in European Union as COP for:

• Non-Hodgkin lymphoma
• Hodgkin lymphoma

Who Is Running the Clinical Trial?

St. Jude Children's Research Hospital

Lead Sponsor

Trials

451

Recruited

5,326,000+

Published Research Related to This Trial

The combination of biweekly THP-COP chemotherapy and radiotherapy resulted in a high 5-year overall survival rate of 89% and a cause-specific survival rate of 90% in 41 patients with early-stage non-Hodgkin's lymphoma.

Despite some patients experiencing grade 4 neutropenia (12%), the treatment was well-tolerated, with 93% of patients completing the chemotherapy as scheduled, indicating that this regimen is both feasible and effective for low-risk cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of modified version of CHOP plus radiotherapy for early-stage aggressive non-Hodgkin's lymphoma of the head and neck. Nishioka, T., Tsuchiya, K., Nishioka, S., et al.[2015]

The COAD-B chemotherapy regimen showed a 67.4% overall response rate in 86 patients with relapsed or refractory non-Hodgkin lymphoma, with a median remission duration of 13 months.

Patients who responded to COAD-B had better long-term survival rates, with 1-, 2-, and 4-year overall survival rates of 75.4%, 56.8%, and 40.0%, respectively, although the main adverse effect observed was myelosuppression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical study of COAD-B regimen in treatment of patients with relapsed/refractory non-Hodgkin lymphoma]. Li, MH., Li, YF., Yin, QS., et al.[2013]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/7683712/

Effective therapy for poor-prognosis non-Hodgkin's ... Fifty-seven patients (81%) obtained a complete response (CR) and the actuarial 5-year failure-free survival rate is 52%. Thirty-seven patients remain alive and ...

2. jenci.springeropen.com jenci.springeropen.com/articles/10.1186/s43046-025-00288-w

Effect of cyclophospamide, doxorubicin, vincristine and ... This study examines left ventricular dysfunction and structural abnormalities in NHL patients receiving CHOP therapy with cumulative doxorubicin doses ≥ 250 mg ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0006497120701539

Combination Chemotherapy of Advanced Non-Hodgkin ... The objective response in 44 evaluable nonleukemic patients with diffuse histology was 86%, with 66% achieving a complete remission (CR), varying from 80% for ...

4. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)61429-8/fulltext

Vincristine, doxorabicin, cyclophosphamide, prednisone ... The 1-, 3- and 5-year overall survivals for the entire VACPE group were 79%, 64% and 61%, respectively. Forty-one patients are in ongoing CR with a continuous ...

5. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/3113/533666/Cyclophosphamide-Mitoxantrone-Hydrochloride

Cyclophosphamide, Mitoxantrone Hydrochloride Liposome ... The MAIC analysis in DLBCL patients showed that CMOP±R achieved a slightly improved response compared to the R-CHOP (weighted ORR 94.6% vs 83.8% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9752891/

CDOP) in non-Hodgkin's lymphoma: A systematic review and ... Conclusion: Our findings suggested that the (R)-CDOP regimen had a lower risk of cardiovascular adverse events in non-Hodgkin's lymphoma than ...

7. ascopubs.org ascopubs.org/doi/10.1200/jco.2006.24.18_suppl.17532

Safety analysis of a phase II study of cyclophosphamide ... Phase II trial of pegylated liposomal doxorubicin (PLD), rituxan, cyclophosphamide, vincristine, and prednisone in aggressive B-cell non-Hodgkin's lymphoma.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3269216/

a fresh look at anthracyclines in non-Hodgkin's lymphoma - PMC In this paper, a brief history of the development of anthracyclines, their use in NHL, and the management of anthracycline-related cardiotoxicity are presented.

9. eviq.org.au eviq.org.au/haematology-and-bmt/lymphoma/nk-cell-and-t-cell-lymphoma/69-chop21-cyclophosphamide-doxorubicin-vincristin

69-CHOP21 (CYCLOPHOSPHamide DOXOrubicin ... Non-Hodgkin lymphoma CHOP21 (CYCLOPHOSPHamide DOXOrubicin vinCRISTine prednisolone) ... For safe administration of vincristine refer to the safety alert ...