Odronextamab + Chemotherapy for Follicular Lymphoma (OLYMPIA-2 Trial)
Recruiting in Palo Alto (17 mi)
+115 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Regeneron Pharmaceuticals
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called odronextamab combined with chemotherapy for people with a type of blood cancer called follicular lymphoma. It aims to find out how safe and effective this combination is, especially for those who haven't been treated before or whose cancer came back or didn't respond to previous treatments. The study will also compare this new treatment to the current standard treatment and look at side effects and quality of life.
Is the drug combination of Odronextamab and chemotherapy promising for treating follicular lymphoma?Yes, the combination of Odronextamab with chemotherapy drugs like rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone is promising for treating follicular lymphoma. Rituximab, in particular, is known to work well with chemotherapy, and adding it to treatments has shown strong effects in similar conditions. This combination aims to improve the effectiveness of treatment by using multiple drugs that work together.356711
What safety data is available for Odronextamab + Chemotherapy in treating Follicular Lymphoma?The safety data for the components of the treatment, such as rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, is available from studies on similar regimens like R-CHOP and CODOX-M/IVAC. These studies indicate that while these regimens are effective, they can cause severe adverse drug reactions, especially in immunocompromised populations. Rituximab, when added to these regimens, has shown survival benefits but also raises concerns about increased toxicity. Monitoring and managing adverse reactions are crucial for patient safety.137910
What data supports the idea that Odronextamab + Chemotherapy for Follicular Lymphoma is an effective treatment?The available research does not provide specific data on the effectiveness of Odronextamab + Chemotherapy for Follicular Lymphoma. However, it mentions other treatments like R-CHOP and R-DHAOx, which have been used for follicular lymphoma. R-CHOP has been a standard treatment for two decades, and R-DHAOx has shown strong long-term effects in previously treated patients. These treatments are part of the broader category of chemoimmunotherapy, which includes drugs like rituximab, used in various combinations to treat follicular lymphoma. While Odronextamab is not specifically mentioned, the effectiveness of similar treatments suggests that combining chemotherapy with targeted therapies can be beneficial for follicular lymphoma.245811
Do I need to stop my current medications to join the trial?The protocol does not specify if you need to stop your current medications. However, since the trial involves chemotherapy, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for specific guidance.
Eligibility Criteria
Adults with previously untreated follicular lymphoma can join this trial. They should be able to perform daily activities (ECOG 0-2) and have a certain level of disease severity (FLIPI-1 score). Participants must not have other types of lymphomas, recent major surgeries, organ transplants, or any condition that could risk their safety in the study.Inclusion Criteria
My lymphoma is CD20 positive and is either stage II bulky or stage III/IV.
My FLIPI score for lymphoma is between 0 and 5, and I haven't been treated yet.
I am able to get out of my bed or chair and move around.
My cancer can be measured on a CT or MRI scan.
Exclusion Criteria
My lymphoma has changed into a more aggressive form.
I have lymphoma in my brain or spinal cord.
I have been diagnosed with a specific type of blood cancer.
I have no other major illnesses that could affect my participation in the study.
Participant Groups
The trial is testing odronextamab combined with chemotherapy against the standard rituximab with chemotherapy. It's divided into three parts: initial non-randomized phases to determine safe dosages and a final phase comparing effectiveness between treatments.
4Treatment groups
Experimental Treatment
Active Control
Group I: Odronextamab + Chemotherapy + No maintenanceExperimental Treatment2 Interventions
In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance.
Group II: Odronextamab + Chemotherapy + MaintenanceExperimental Treatment2 Interventions
In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy \[CHOP, or cyclophosphamide, vincristine, and prednisone (CVP)\], followed by odronextamab monotherapy maintenance.
Group III: Odronextamab + ChemotherapyExperimental Treatment4 Interventions
Part 1 of the study includes ordonextamab dose escalation for participants with previously untreated FL and relapsed/refractory FL (Part 1A only) followed by a randomized exploration of 2 regimens of odronextamab (Odro) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) with the objective of dose optimization (Part 1B) in previously untreated patients with FL.
Group IV: Rituximab + ChemotherapyActive Control6 Interventions
In Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance.
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
🇺🇸 Approved in United States as Cytoxan for:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
🇪🇺 Approved in European Union as Endoxan for:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
🇨🇦 Approved in Canada as Neosar for:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
🇯🇵 Approved in Japan as Endoxan for:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Henry Ford HospitalDetroit, MI
Cancer and Hematology Centers of Western MichiganGrand Rapids, MI
Community Cancer Trials of UtahOgden, UT
Clinical Research Alliance, Inc.Westbury, NY
More Trial Locations
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Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
References
Pilot study of modified version of CHOP plus radiotherapy for early-stage aggressive non-Hodgkin's lymphoma of the head and neck. [2015]To evaluate the safety and efficacy of a modified version of cyclophosphamide, doxorubicin, vincristine, prednisone (pirarubicin, cyclophosphamide, vincristine, and prednisone [THP-COP]) plus radiotherapy for early-stage aggressive non-Hodgkin's lymphoma of the head and neck.
Salvage chemotherapy in follicular non-Hodgkin's lymphoma: focus on tolerability. [2006]Follicular lymphoma (FL) is typically characterized by repeated remissions and relapses, and many patients receive a number of therapeutic interventions during their disease course. Although treatment options are evolving rapidly, stem cell transplantation offers a potentially favorable impact on survival. In general, many patients with FL are not eligible for this approach by virtue of age and/or comorbid disease. Salvage chemotherapy consequently remains the mainstay of treatment, being individualized according to disease and patient characteristics, goals of therapy, and patient preference. Many of the cytotoxic agents used in relapsed FL are highly myelotoxic, leading to significant morbidity and mortality, including febrile neutropenia, hemorrhage, and impaired quality of life. Nausea and vomiting can also be problematic, particularly with regimens incorporating carmustine, cisplatin, and high-dose cyclophosphamide. Other acute toxicities include mucositis, alopecia, extravasation injuries, and neurotoxicity. Late toxicities can also occur, sometimes months or even years after the administration of antineoplastic agents. Acute myeloid leukemias, myelodysplastic syndromes, or solid tumors can occur after chemotherapy with alkylating agents. The cardiotoxic profile of anthracycline antibiotics is well recognized, and several agents, including carmustine and cyclophosphamide, can cause lung injury. Persistent neurotoxicity, nephrotoxicity, ototoxicity, and vascular toxicity have also been reported in association with chemotherapeutic agents used in patients with relapsed FL. Novel therapeutic strategies might allow patients to achieve longer remissions, potentially reducing lifetime exposure to repeated cycles of chemotherapy and their attendant toxicities. These could include the use of more efficient preparative and purging approaches in the transplantation setting or the administration of rituximab maintenance therapy after (immuno) chemotherapy induction or transplantation.
[Results of dose-intense, dose-impact weekly combination chemotherapy with rituximab for patients with CD 20-positive B-cell non-Hodgkin's lymphoma]. [2015]Excellent results were reported for dose-dense and dose-intense weekly combination chemotherapy (cyclophosphamide, doxorubicin, vincristine, etoposide and additional ara-C) (CHOEA-7) and with rituximab (RCHOEA-7), for patients with CD 20-positive non-Hodgkin's lymphoma.
Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma. [2016]Radioimmunotherapy has been approved for relapsed follicular lymphoma (FL), including rituximab-refractory FL. This study was designed to determine the CR rate with short-course chemoimmunotherapy with cyclophosphamide, doxorubicin, vincristine, prednisone, and rituximab (CHOP-R) followed by 90-Y ibritumomab tiuxetan (RIT) with extended rituximab as first-line treatment.
Treatment with rituximab, dexamethasone, high-dose cytarabine, and oxaliplatin (R-DHAOx) produces a strong long-term antitumor effect in previously treated patients with follicular non-Hodgkin's lymphoma. [2015]We explored the addition of rituximab to high-dose cytarabine (ara-C), oxaliplatin (L-OHP), and dexamethasone [R-DHAOx], in resistant and relapsed patients with CD20-positive follicular non-Hodgkin's lymphoma.
Biological therapy doublets: pairing rituximab with interferon, lenalidomide, and other biological agents in patients with follicular lymphoma. [2021]Rituximab (R) is a monoclonal antibody with high therapeutic efficacy in low-grade CD20+ lymphoma. The combination of R with chemotherapy is the most common treatment option for patients with follicular lymphoma (FL). The efficacy of R has also been shown to be augmented, when used in combinations with biologicals such as interferon-alpha-2a (IFN), bortezomib, or lenalidomide. The best combination of these drugs are not well defined and a better understanding of pharmacokinetics and timing of drugs relative to the rituximab infusion is crucial. Other new targeted agents, such as inhibitors of BTK and PI3Kdelta, have also been promising in FL. Translational research questions should be added to clinical trial protocols to increase the knowledge on how the tumor microenvironment and the host immune system affect the response to the different drugs and combinations with the aim of a more individualized therapy.
Adding rituximab to CODOX-M/IVAC chemotherapy in the treatment of HIV-associated Burkitt lymphoma is safe when used with concurrent combination antiretroviral therapy. [2022]CODOX-M/IVAC (cyclophosphamide, vincristine, doxorubicin-methatrexate/ifusamide, etoposide, cytarabine) chemotherapy is commonly used to treat Burkitt lymphoma and in the HIV-negative population. Rituximab is often added with suggested survival benefits. Concerns over increased toxicity in an already immunocompromized population have prevented its routine addition in people living with HIV (PLWH). This study evaluated the effect on treatment-related toxicity and efficacy of adding rituximab to CODOX-M/IVAC chemotherapy in PLWH.
Long-term follow-up of rituximab plus first-line mitoxantrone, chlorambucil, prednisolone and interferon-alpha as maintenance therapy in follicular lymphoma. [2018]The randomised, controlled OSHO#39 study showed promising results using first-line mitoxantrone, chlorambucil and prednisolone (MCP) chemotherapy plus rituximab in patients with advanced symptomatic follicular lymphoma (FL) in need of therapy. The aim of this long-term follow-up was to investigate whether clinical benefits are maintained after up to 9 years of observation.
Infectious diseases and immunological markers associated with patients with non-Hodgkin lymphoma treated with rituximab. [2019]The use of rituximab (RTX) is increasing, even in developing countries. It has become the first-line therapy or adjuvant to chemotherapy (CHOP; cyclophosphamide, hydroxydaunorubicin, oncovin and prednisone) for various diseases, including B cell lymphoma and autoimmune diseases.
Evaluation of Medication Instruction Sheets for Patients Undergoing R-CHOP Therapy in Non-Hodgkin's Lymphoma. [2022]High-dose chemotherapy is frequently administered to patients with hematologic malignancies, thereby causing severe adverse drug reactions (ADRs) at a relatively high frequency. To precisely monitor ADRs, we developed a medication instruction sheet (MIS) for patients who received rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) combination therapy for non-Hodgkin's lymphoma (NHL). Herein, we evaluated the usefulness of the MIS for managing ADRs in patients who received R-CHOP therapy.
The Impact of Sequence of Therapy for Older Patients With Follicular Lymphoma: SEER-Medicare Analysis. [2022]One key clinical challenge remains in how to sequence treatments in follicular lymphoma (FL). The chemoimmunotherapy rituximab cyclophosphamide, doxorubicin, vincristine (Oncovin), and prednisone (R-CHOP) has been a standard treatment option for two decades. However, there are limited data to suggest in which line R-CHOP should be used for older patients.