60 Participants Needed

EO2463 Combination Therapy for Non-Hodgkin's Lymphoma

(SIDNEY Trial)

Recruiting at 11 trial locations
JF
KK
Overseen ByKarlijn Kroon, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to define the recommended Phase 2 Dose, safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 during monotherapy and in combination with lenalidomide and/or rituximab in patients with indolent NHL

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken certain treatments like dexamethasone above a specific dose or immunotherapy within a certain time before starting the trial. It's best to discuss your current medications with the trial team.

Is EO2463 combination therapy for Non-Hodgkin's Lymphoma safe?

The combination of vorinostat and rituximab, which includes rituximab (a component of EO2463 therapy), was generally well tolerated in patients with indolent B-cell non-Hodgkin lymphoma, with common side effects being manageable. Another study on a similar anti-CD20 monoclonal antibody (like rituximab) showed it was well tolerated, with no severe adverse events reported.12345

How is the drug EO2463 different from other treatments for non-Hodgkin's lymphoma?

EO2463 is unique because it is being studied as a combination therapy specifically for non-Hodgkin's lymphoma, potentially offering a new approach compared to existing treatments like monoclonal antibodies and chemotherapy regimens. While other treatments focus on targeting specific molecules or using established chemotherapy drugs, EO2463 may involve novel mechanisms or combinations that are not yet standard in current therapies.678910

What data supports the effectiveness of the drug EO2463 Combination Therapy for Non-Hodgkin's Lymphoma?

The drug rituximab, part of the EO2463 Combination Therapy, has shown effectiveness in treating non-Hodgkin's lymphoma, especially when used with chemotherapy. It is a monoclonal antibody that targets specific molecules on lymphoma cells, and has become a standard treatment for both indolent and aggressive forms of the disease.69111213

Who Is on the Research Team?

JF

Jan Fagerberg, MD

Principal Investigator

Enterome

Are You a Good Fit for This Trial?

Adults over 18 with certain types of indolent Non-Hodgkin Lymphoma (NHL) such as Follicular Lymphoma or Marginal Zone Lymphoma. Participants must have measurable disease, be HLA-A2 positive, and can include both newly diagnosed and those who've relapsed after treatment. Excludes pregnant women, individuals on high-dose steroids, those with aggressive lymphoma subtypes or other recent cancers, uncontrolled brain metastasis, autoimmune disorders, organ transplants, HIV/HBV/HCV infections.

Inclusion Criteria

Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
I am HLA-A2 positive.
I am a male or a female not pregnant or breastfeeding.
See 6 more

Exclusion Criteria

I have previously been treated with EO2463.
I have or might have an autoimmune disorder, including conditions like Guillain-Barré syndrome.
I do not have uncontrolled brain metastasis.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

EO2463 monotherapy for 6 weeks, followed by combination with lenalidomide and/or rituximab

24 months
Weekly visits during initial treatment phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 7 years

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • EO2463
  • Lenalidomide
  • Rituximab
Trial Overview The trial is testing EO2463 alone and in combination with lenalidomide and/or rituximab to determine the optimal dose for Phase 2 trials. It aims to assess safety, tolerability, immune response generation (immunogenicity), and initial effectiveness against indolent NHL.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment3 Interventions
Group II: Cohort 3Experimental Treatment2 Interventions
Group III: Cohort 2Experimental Treatment1 Intervention
Group IV: Cohort 1Experimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Enterome

Lead Sponsor

Trials
9
Recruited
550+

Published Research Related to This Trial

In a study of 18 patients with advanced aggressive non-Hodgkin's lymphoma, a combination treatment of mitoxantrone, etoposide, cisplatin, and prednisolone resulted in a 61% overall response rate, with four complete and seven partial responses.
The treatment was generally well-tolerated despite myelosuppression being the main side effect, and responders had a median survival time of 52 weeks compared to 24 weeks for nonresponders, suggesting the regimen's potential effectiveness in relapsed or resistant cases.
Salvage chemotherapy for non-Hodgkin's lymphoma with a combination of mitoxantrone, etoposide, cisplatin, and prednisolone.Ohnoshi, T., Hayashi, K., Ueoka, H., et al.[2013]
Intensifying drug regimens for intermediate- and high-grade non-Hodgkin's lymphomas has successfully improved cure rates, especially with the use of growth factors and stem cell transfusions to manage side effects.
In low-grade lymphomas, while intensive therapy is more controversial, promising results show that durable remissions can be achieved in advanced-stage patients through low-dose radiation or autologous transplantation, particularly in those with good prognostic factors.
Management of non-Hodgkin's lymphoma.Portlock, CS.[2019]
The introduction of new combination chemotherapy regimens in the 1970s significantly improved treatment outcomes for patients with aggressive non-Hodgkin's lymphoma (NHL).
Recent controlled studies have shown that newer, more intensive treatment regimens have not consistently led to better results, raising questions about the effectiveness of these advancements.
Treatment of aggressive non-Hodgkin's lymphoma in adults--are we doing any better?Hagberg, H., Kimby, E.[2020]

Citations

Salvage chemotherapy for non-Hodgkin's lymphoma with a combination of mitoxantrone, etoposide, cisplatin, and prednisolone. [2013]
Management of non-Hodgkin's lymphoma. [2019]
Treatment of aggressive non-Hodgkin's lymphoma in adults--are we doing any better? [2020]
Treatment of aggressive histology lymphoma. [2019]
Antibody therapy for non-Hodgkin's lymphoma. [2015]
Dose-adjusted EPOCH-R vs. R-CHOP in frontline management of Waldeyer's ring diffuse large B-cell lymphoma: a retrospective study from a single institution. [2023]
Mitoxantrone, Etoposide and bleomycin (meb) chemotherapy in non-hodgkins-lymphoma patients non-elegible for standard cyclophosphamide, Doxorubicin, vincristine and prednisone (chop) combination. [2019]
A phase II study of vorinostat and rituximab for treatment of newly diagnosed and relapsed/refractory indolent non-Hodgkin lymphoma. [2018]
[MECHOP-BM chemotherapy in the treatment of non Hodgkin's lymphoma]. [2006]
[Tolerance and pharmacodynamics phase Ⅰ clinical trial study of chimeric anti-CD20 monoclonal antibody IBI301 in Chinese patients with CD20-positive non-Hodgkin's lymphoma]. [2020]
Oral etoposide in lymphoma. [2018]
ESHAP as salvage therapy for refractory non-Hodgkin's lymphoma: Taiwan experience. [2019]
E-SHAP: inadequate treatment for poor-prognosis recurrent lymphoma. [2020]
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