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Lymphoma clinical trials

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NCT ID: NCT06253663 Recruiting - Clinical trials for Relapsed/Refractory Mantle Cell Lymphoma

Study of KTE-X19 in Adult Japanese Participants With Relapsed/Refractory Mantle Cell Lymphoma or Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia

JKART-1
Start date: March 18, 2024
Phase: Phase 2
Study type: Interventional

The goal of this clinical study is to learn more about KTE-X19, and how safe and effective it is in adult Japanese participants with relapsed/refractory (r/r) Mantle Cell Lymphoma (MCL) or r/r B-precursor Acute Lymphoblastic Leukemia (B-ALL). The primary objectives of this study are to evaluate the efficacy of KTE-X19, as measured by: - Objective response rate (ORR) per investigator assessment, in adult Japanese participants with r/r MCL - Overall complete remission (OCR) defined as complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) per investigator assessment, in adult Japanese participants with r/r ALL

NCT ID: NCT06251180 Recruiting - Clinical trials for B-cell Non-Hodgkin Lymphoma

Phase Ib Study of Rocbrutinib in Combination With R-CHOP in Patients With Newly Diagnosed B-cell Non-Hodgkin Lymphoma

Start date: April 10, 2024
Phase: Phase 1
Study type: Interventional

This is an open-label, multicentre Phase Ib study to evaluate the safety and preliminary efficacy of new generation Bruton Tyrosine Kinase inhibitor Rocbrutinib in combination to R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristin, Prednison) in adult patients with newly diagnosed, previously untreated B-cell Non-Hodgkin Lymphoma [Diffuse Large B-cell Lymphoma (DLBCL), Marginal Zone Lymphoma (MZL) or Mantle Cell Lymphoma (MCL)].

NCT ID: NCT06248086 Recruiting - B-cell Lymphoma Clinical Trials

A Study to Find a Suitable Dose of ASP2802 in People With CD20-positive B-cell Lymphomas

Start date: April 19, 2024
Phase: Phase 1
Study type: Interventional

CAR-T cell therapy is a type of treatment for people with certain lymphomas. T-cells are white blood cells that help to fight infections. CAR-T cell therapy improves the body's T-cells to help them better fight cancer cells. ASP2802 is a type of CAR-T cell therapy given with MA-20. MA-20 is a protein that helps the CAR-T cell therapy work inside the body. Before ASP2802 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help find a suitable dose for future studies and check for potential medical problems from the treatment. In this study, ASP2802 is being tested in humans for the first time. ASP2802 has already been tested in the laboratory and in animals. This is the standard way new potential treatments are developed. People taking part in this study will be adults with CD20-positive B-cell lymphomas. CD20 is a protein found on a type of white blood cell called a B-cell. Some people with B-cell lymphomas have more CD20 on these cells. Their cancer will have come back after it had disappeared with earlier therapy (relapsed) or it will have become resistant to previous treatment (refractory). The main aims of the study are to check the safety of ASP2802, how well it is tolerated, and to find a suitable dose of ASP2802. This is an open-label, adaptive study. Open-label means that people in this study and clinic staff will know that people will receive ASP2802 treatment. Adaptive means the treatments may change, depending on earlier results in the study. There will be 3 groups of people in this study and 3 doses of ASP2802. Groups A, B and C will receive ASP2802 treatment. Group A will start treatment first with a low dose of ASP2802. If Group A tolerates the low dose of ASP2802, then Group B will receive the higher dose of ASP2802. If Group B tolerates the higher dose of ASP2802, then Group C will receive the highest dose of ASP2802. There are several steps in this treatment. First, T-cells are removed from the blood by inserting a small tube (cannula) into a vein and connecting it to a machine that separates out the blood cells. The machine collects the T-cells and returns the rest of the blood cells back into the bloodstream. The collected T-cells are sent to the lab to be changed into improved T-cells (with ASP2802) to fight the cancer. This may take several weeks, so people in the study may receive extra treatment, to keep the cancer under control during this time. Before the improved T-cells go back in the body, people will visit the clinic so that the study doctors can do a series of checks to make sure they are well enough to receive the T-cells. A few days before the improved T-cells go back into the body, people in the study will have chemotherapy for 3 days. This is to make sure the cancer is at its lowest level before people are treated with ASP2802. Then, the improved T-cells are fed back into the bloodstream using a drip attached to the cannula. After this, a booster of MA-20 will be given at the set dose by infusion on Day 3 and Day 17 in a 28-day cycle. If people respond well to treatment, they may stay on the same dose during the next cycle; if they have medical problems from the treatment, they may get a lower dose during the next cycle. The next group of people may receive a different dose (higher or lower) of MA-20 depending on the results from the previous group. People in the study will continue receiving MA-20 in this way until: they have certain medical problems from the treatment on the lowest dose of MA-20; they start other cancer treatment; their cancer gets worse; they or the study doctor decides they should stop treatment; they do not come back for treatment. After treatment has finished, people in the study will visit the clinic regularly for 2 years and continue to be monitored for up to 15 years. Some people may be treated again with MA-20. This may happen for people who have responded to treatment and then relapse within a year, or for people that have a partial response and have a slow growing lymphoma. During the study, people will visit the study hospital many times. During most visits, the study doctors will do a medical examination, blood tests and check vital signs. Vital signs include temperature, breathing rate, blood pressure, blood oxygen levels, and heart rate. They will also check for medical problems. In some visits, computerized tomography (CT) scans and electrocardiograms (ECGs) to check the heart rhythm will also be done. People will have several hospital stays during their treatment. This may be during their chemotherapy, then from Days -1 to 7 and Days 17 to 21 during the cycle 1 of MA-20. Day -1 means 1 day before treatment with ASP2802. During this time, people will be closely monitored for medical problems, have EGCs and have a biopsy taken. During the extra cycles of MA-20, there will be the option of staying overnight.

NCT ID: NCT06244368 Recruiting - Clinical trials for Diffuse Large B-cell Lymphoma

GVM±R in Patients With Relapsed or Refractory Aggressive NHL.

Start date: January 17, 2024
Phase: Phase 2
Study type: Interventional

This is a prospective clinical study to evaluate the safety and efficacy of GVM±R in patients with relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL).

NCT ID: NCT06241729 Recruiting - Lymphoma, B-Cell Clinical Trials

Prospective Observational Study of Diffuse Large-cell B Lymphoma

LBDGCréfract
Start date: January 3, 2023
Phase:
Study type: Observational

Diffuse large B-cell lymphoma (DLBCL) represents the most common type of non-Hodgkin lymphoma and is currently a curable malignant disease for many patients with immuno-chemotherapy frontline treatment. However, around 30-40 % of patients, are unresponsive or will experience early relapse. The prognosis of primary refractory patient is poor and the management and treatment are a significant challenge due to the disease heterogeneity and the complex genetic framework. The reasons for refractoriness are various and include genetic abnormalities, alterations in tumor and tumor microenvironment. Patient related factors such as comorbidities can also influence treatment outcome. Recently the progress in Machine learning (ML) showed its usefulness in the procedures used to analyze large and complex datasets. In medicine, machine learning is used to create some predictive tools based on data-driven analytic approach and integration of various risk factors and parameters. Machine learning, as a subdomain of artificial intelligence (AI), has the capability to autonomously uncover patterns within datasets. It offers algorithms that can learn from examples to perform a task automatically.The investigators tested in a previous study five machine learning algorithms to establish a model for predicting the risk of primary refractory DLBCL using parameters obtained from a monocentric dataset. The investigators observed that NB Categorical classifier was the best alternative for building a model in order to predict primary refractory disease in DLBCL patients and the second was XGBoost.The investigators plan to extend this previous study by further exploring the two best-performing models (NBC Classifier and XGBoost), progressively incorporating a larger number of patients in a prospective way.

NCT ID: NCT06236373 Recruiting - Breast Cancer Clinical Trials

The Unmet Needs of Cancer Survivors in Ausl IRCCS Reggio Emilia

Survivorship
Start date: April 20, 2023
Phase:
Study type: Observational

This qualitative study seeks to explore the unmet needs of individuals who have recently undergone a cancer diagnosis and completed the acute phase of treatment. The primary objective is to utilize the experiences of patients, caregivers, and stakeholders to enhance the aftercare provided to cancer survivors. By delving into patient perceptions regarding unmet needs in cancer aftercare, the study aims to identify areas for redesigning and improving services to minimize these needs and ultimately enhance patient outcomes. Importantly, the investigation incorporates insights from patients, their caregivers, and stakeholders. The research will employ qualitative methods, specifically focus groups and interviews, to gather comprehensive perspectives from individuals in the Ausl IRCCS Reggio Emilia district who have completed treatment for breast, prostate, colorectal, thyroid, and multiple myeloma cancers. Including patients with diverse cancer types is crucial for capturing a broad spectrum of experiences. During data collection, both focus group discussions and interviews will be recorded in audio format and transcribed verbatim. This meticulous approach ensures an accurate representation of participants' voices and experiences. The subsequent analysis will employ a combination of framework and thematic analysis to extract meaningful insights and synthesize the data effectively. The study's ultimate goal is to leverage the findings to optimize aftercare services for cancer survivors within the local context of Ausl IRCCS Reggio Emilia. By incorporating the perspectives of patients, caregivers, and stakeholders, the research aims to contribute valuable insights that can inform the redesign and improvement of aftercare services, ultimately benefitting cancer survivors in the region.

NCT ID: NCT06230224 Recruiting - Clinical trials for B-Cell Non-Hodgkin Lymphoma (B-NHL)

A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma

OLYMPIA-4
Start date: February 15, 2024
Phase: Phase 3
Study type: Interventional

The study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding to treatment (also known as 'refractory') or has returned (also known as 'relapsed'). The aim of the study is to see how effective the study drug is compared to standard of care (SOC) therapy. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug versus SOC - 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) - Comparing the impact from the study drug versus SOC on your quality-of-life and ability to complete routine daily activities

NCT ID: NCT06228963 Recruiting - Clinical trials for Helicobacter Pylori Infection

Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Start date: March 2024
Phase: Phase 2
Study type: Interventional

Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma

NCT ID: NCT06224842 Recruiting - Clinical trials for Angioimmunoblastic T-cell Lymphoma

Clinical Study of Mitoxantrone Liposome and Azacitidine in the Treatment of R/R AITL

Start date: December 12, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study is an open-label, single-arm Phase Ib/II clinical trial designed to evaluate the safety and efficacy of the combination therapy with mitoxantrone liposome and azacitidine in the treatment of relapsed/refractory angioimmunoblastic T-cell lymphoma(R/R AITL). The study includes two parts: a dose escalation phase and a dose expansion phase, each comprising screening, treatment, and follow-up periods. In the dose escalation phase, the mitoxantrone liposome injection will start at a dose of 16 mg/m^2 on day1, combined with subcutaneous injection of azacitidine at a dose of 75 mg/m^2 on days 1-7, with each cycle lasting 4 weeks (28 days). Three predetermined dose groups for mitoxantrone liposome are 16, 18, and 20 mg/m^2. In the dose expansion phase, 10-20 cases will be included with the mitoxantrone liposome injection at the recommended phase II dose (RP2D) based on the results of the dose escalation phase. After the treatment period, safety and survival information will be collected during the follow-up period. This study aims to comprehensively evaluate the safety and efficacy of mitoxantrone liposome in combination with azacitidine for the treatment of R/R AITL, exploring a combination therapy that offers higher survival benefits with limited adverse reactions and providing new therapeutic approaches for R/R AITL.

NCT ID: NCT06224049 Recruiting - T-cell Lymphoma Clinical Trials

Treatment of Relapsed or Refractory Epstein-Barr Virus Positive T-cell Lymphoma With hNeo-T

GI-hNeoT-01
Start date: December 1, 2023
Phase: Early Phase 1
Study type: Interventional

Objective: To evaluate the safety and tolerability of hNeo-T injection in patients with relapsed or refractory EBV-positive T-cell lymphoma. Secondary objective: To evaluate the effectiveness of hNeo-T injection, and to evaluate the objective response rate (ORR) and disease control rate (DCR) by Lugano2014 criteria; Progression-free survival (PFS), duration of response (DOR), and overall survival (OS ) followed. Objective of the exploratory study: To investigate the in vivo process of hNeo-T injection and describe the activity and related biological functions of hNeo-T cells in vivo, including but not limited to.