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Lymphoma, Follicular clinical trials

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NCT ID: NCT06097364 Recruiting - Clinical trials for Follicular Lymphoma (FL)

A Study to Learn How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Compared to Rituximab and Chemotherapy in Adult Participants With Previously Untreated Follicular Lymphoma

OLYMPIA-2
Start date: November 14, 2023
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma in Part 2, as well as participants with lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory"), in Part 1. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled). The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy to be used in Part 2 of the study. The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab and chemotherapy (the current standard-of-care for NHL). Standard-of-care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) - The impact from the study drug on your quality-of-life and ability to complete routine daily activities

NCT ID: NCT06091254 Recruiting - Clinical trials for Follicular Lymphoma (FL)

A Trial to Learn if Odronextamab is Safe and Well-tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma

OLYMPIA-1
Start date: December 12, 2023
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is. The aim of Part 2 of the study is to see how the study drug works compared to rituximab and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is in your blood at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects) - The impact from the study drug on your quality of life and ability to complete routine daily activities.

NCT ID: NCT06070961 Recruiting - Follicular Lymphoma Clinical Trials

Prospective Biological Study to Evaluate the Persistence of COVID-19 Vaccine and Other Vaccines'-Induced Immune Responses in Follicular Lymphoma Patients Undergoing Frontline Induction Immuno-chemotherapy and Anti-CD20 Maintenance

FIL_FollVax22
Start date: May 7, 2024
Phase:
Study type: Observational

This is a prospective biological study evaluating the persistence of COVID-19 vaccine and other vaccines' (zoster, diphtheria and tetanus)-induced immunity in a subgroup patient affected by Follicular Lymphoma requiring treatment undergoing frontline induction immuno-chemotherapy and anti-CD20 maintenance within the prospective FIL_FOLL19 study (NCT05058404). Blood samples from patients will be collected before and at planned timepoints during treatment to evaluate humoral and cellular immunity against SARS-COV-2, VZV, tetanus and diphtheria and T-cell markers characterization.

NCT ID: NCT06068881 Not yet recruiting - Follicular Lymphoma Clinical Trials

A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lymphoma That Does Not Have an "EZH2 Gain-of-function" Genetic Mutation

Mandolin
Start date: September 2, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to learn about the effectiveness and safety of the study drug, tazemetostat, in adults with relapsed/refractory follicular lymphoma whose tumours do not have an "EZH2 gain-of-function" genetic mutation. Follicular lymphoma is a blood cancer. It affects white blood cells called lymphocytes. White blood cells normally help to fight infections, but when you have follicular lymphoma, the blood cells can form tumours in your body. 'Relapsed/refractory' follicular lymphoma means the disease has either not improved or is getting worse (progressing) during or after previous treatment. Tazemetostat already has approval in the United States for the treatment of adult patients with relapsed/refractory follicular lymphoma with or without the "EZH2" mutation who have no satisfactory alternative treatment options. This study is being conducted to better understand the effectiveness in patients whose tumours do not have an "EZH2 gain-of-function" genetic mutation and who previously received therapies commonly used in the U.S. in your body. 'Relapsed/refractory' follicular lymphoma means the disease has either not improved or is getting worse (progressing) during or after previous treatment. Tazemetostat already has approval in the United States for the treatment of adult patients with relapsed/refractory follicular lymphoma with or without the "EZH2 gain-of-function" mutation who have no satisfactory alternative treatment options. This study is being conducted to better understand the effectiveness in patients whose tumours do not have an "EZH2" genetic mutation and who previously received therapies commonly used in the U.S. In this study, all participants will receive the study drug. It will be taken by mouth (orally), as a tablet, twice daily. The sizes and number of tumours according to scan results will be collected as well as results of safety tests (such as physical examinations and laboratory tests). The study consists of 4 periods: - Screening period may take up to 4 weeks and require at least 1 visit. - Treatment period will require 2 visits for each of the first 2 months, followed by 1 visit every month for the remainder of the first 12 months, followed by 1 visit every 3 months (except for women of childbearing potential [WOCBP], who will continue to have a pregnancy testing every month) until unacceptable toxicity, disease progression, or the start of new systemic anticancer therapy, whichever is first. - Safety follow-up period will last for 1 month after the last dose of tazemetostat, and it will end with 1 visit or telephone call. - Long-term follow-up period is only for participants who stop taking tazemetostat while their disease continues to respond; this period will last until disease progression, start of new cancer treatment, or death from any cause, whichever is first, and will require a visit every 3 months. Tazemetostat will be provided to participants who tolerate it for as long as their disease does not progress. Participants may be transferred to another study or program after about 2 years for continued treatment with tazemetostat or for long-term follow-up. Patients may withdraw consent to participate at any time.

NCT ID: NCT06049485 Not yet recruiting - Follicular Lymphoma Clinical Trials

Assessing the Experience of Patients Undergoing Follicular Lymphoma Clinical Research

Start date: October 2024
Phase:
Study type: Observational

Historically, participation in medical studies is highly skewed towards particular demographic groups of people. This research will invite several participants to gather a wide range of information on clinical trial experiences for follicular lymphoma patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of follicular lymphoma. The data collected from this study will help improve future outcomes for all follicular lymphoma patients as well as those in under-represented demographic groups.

NCT ID: NCT06045910 Recruiting - Clinical trials for Lymphoma, Non-Hodgkin

A Phase I/II Trial of ALETA-001 for the Treatment of Participants With B-cell Malignancies

Start date: January 19, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase I/II multicentre, open-label trial designed to evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of a novel chimeric antigen receptor (CAR) T-cell engager, ALETA-001, administered by intravenous (IV) infusion as a single agent every 2 weeks in patients with relapsed non-Hodgkin lymphoma (NHL) who have failed to optimally respond to prior treatment with anti-CD19 CAR T-cell therapy. This first in human study is divided into 2 parts: a safety lead-in phase (Phase I) and a dose expansion phase (Phase II). Different dose levels of ALETA-001 will be evaluated in Phase I in order to define a recommended dosing level and schedule for Phase II. Phase II will further evaluate the safety, PK and therapeutic activity of ALETA-001.

NCT ID: NCT06043323 Recruiting - Follicular Lymphoma Clinical Trials

A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma

Start date: January 8, 2024
Phase: Phase 2
Study type: Interventional

To learn about the safety of a drug called axicabtagene ciloleucel given in combination with radiation therapy to patients with relapsed/refractory FL.

NCT ID: NCT06026319 Recruiting - Clinical trials for Mantle Cell Lymphoma

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Start date: October 26, 2023
Phase: Phase 1
Study type: Interventional

This research study involves the study of CD79b-19 CAR T cells for treating people with relapsed/refractory Non-Hodgkin Lymphoma and to understand the side effects when treated with CD79b-19 CAR T cells. This research study involves the study drugs: - CD79b-19 CAR T cells - Fludarabine and Cyclophosphamide: Standardly used chemotherapy drugs as part of lymphodepleting process

NCT ID: NCT05994235 Recruiting - Follicular Lymphoma Clinical Trials

Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma

Start date: November 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this study is to learn about the safety and effectiveness of the combination of tazemetostat pills in combination with mosunetuzumab injections for people with follicular lymphoma who haven't received treatment before. The investigators hypothesize that tazemetostat with mosunetuzumab has the potential to increase the efficacy of the product without compromising the safety. Tazemetostat is a drug that inhibits EZH2, an enzyme known to drive the development of B-cell lymphomas, and inhibiting it appears to have many effects that slow down lymphoma growth and enhance the immune system's ability to fight it. Tazemetostat is FDA-approved in previously treated follicular lymphoma and currently undergoing study in other lymphomas. Mosunetuzumab is a bispecific antibody therapy that is a therapeutic strategy that uses the immune system to fight lymphoma, called immunotherapy. Bispecific antibodies have two ends: one attaches to T cells in the immune system and the other attaches to lymphoma cells, helping guide our immune system to attack the cancer. Mosunetuzumab has been studied in follicular lymphoma that has previously been treated, with positive results. Mosunetuzumab is approved by the FDA to be given intravenously (directly into a vein) but is not yet approved by the FDA is not yet approved as an injection under the skin, which is how it is given in this study. They have not yet been studied in combination.

NCT ID: NCT05929222 Recruiting - Follicular Lymphoma Clinical Trials

Comparison Between Local Radiotherapy Alone or Combined With Obinutuzumab in Early Stage Follicular Lymphoma: the GAZEBO Trial From the Fondazione Italiana Linfomi

FIL_GAZEBO
Start date: December 14, 2023
Phase: Phase 3
Study type: Interventional

Prospective, multicenter, open label, phase III randomized clinical trial in previously untreated Follicular Lymphoma in early stage. Patients will be randomized to receive Radiotherapy or Radiotherapy plus Obinutuzumab.