Mantle Cell Lymphoma

Researchers are evaluating a new type of CAR T cell therapy called 4SCAR19U T cells for treating patients with CD19-positive B cell malignancies. This phase I trial aims to assess the feasibility, safety, and effectiveness of this universal CAR T cell product in patients who have relapsed or refractory hematological cancers. The study also investigates how these cells function and persist in the body. The trial is sponsored by Shenzhen Geno-Immune Medical Institute and conducted at multiple centers. The 4SCAR19U T cells are genetically engineered and produced in large amounts, allowing them to be stored and used off-the-shelf without needing to be custom-made for each patient. This makes treatment quicker and potentially more accessible, especially for patients with rapidly progressing disease or weakened immune systems after chemotherapy or radiotherapy. Participants will receive infusions of these universal CD19-specific CAR T cells as the investigational therapy. Participants will be monitored for safety over 24 weeks following the infusion to observe any side effects or adverse events. The study will also evaluate the anti-tumor activity of the 4SCAR19U cells for up to one year. Assessments include clinical evaluations, laboratory tests, and tracking of the cells persistence in the body. The trial plans to enroll patients aged from 6 months to 75 years, with specific health and response criteria, and participation could last until the studys end date in 2030.

Researchers are studying the use of Hanlikang and BTK inhibitors in treating patients newly diagnosed with mantle cell lymphoma. This clinical study is open-label, single-arm, and conducted at multiple centers to observe treatment effects and safety in this patient group. The study aims to evaluate progression-free survival over two years among other important outcomes. The treatment involves combining Rituximab, Bendamustine, Cytarabine, and Prednisone referred to as R-BAP with BTK inhibitors. Younger patients under 65 receive six cycles of R-BAP with oral ibrutinib during chemotherapy and continue ibrutinib for one year after. Patients 65 and older receive four cycles of R-BAP, followed by four cycles of rituximab consolidation and one year of oral zanubrutinib. Treatment responses and side effects are regularly assessed. Participants will undergo regular evaluations including efficacy assessments every two cycles during chemotherapy and every three months during the BTK inhibitor maintenance phase. Researchers will monitor progression-free survival, response rates, overall survival, and adverse reactions over two years. The study requires participants to cooperate with follow-up visits and use contraception if of childbearing potential. Total participation duration aligns with treatment and follow-up timelines.

Researchers are evaluating ONM-501, a drug given as intratumoral injections, alone and in combination with cemiplimab, an immune checkpoint inhibitor, in patients with advanced solid tumors and lymphomas. This phase 1 study aims to find the maximum tolerated dose, minimum effective dose, and recommended dose for expansion of ONM-501. The study includes patients with various advanced cancers who have no alternative standard therapies available. The trial has three parts monotherapy dose escalation, combination therapy dose finding, and combination therapy dose expansion. ONM-501 is given once per week for three weeks followed by three weeks off, in 21-day cycles. Cemiplimab is given intravenously every three weeks during the combination phases. Dose escalation uses special methods to gradually increase doses, and after doses are established, patients will enroll in expansion cohorts for specific tumor types. Participants will have regular assessments including monitoring for side effects, blood tests to measure drug levels, and evaluation of tumor response over up to 24 months. Researchers will track treatment-emergent adverse events, dose-limiting toxicities, and serious adverse events. Outcomes such as objective response rate, duration of response, progression-free survival, and overall survival will also be recorded. The study involves close safety monitoring and follow-up throughout the treatment and observation periods.

Researchers are evaluating BGB-16673, an oral drug, in adults with various types of B-cell malignancies such as marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenstrm macroglobulinemia, diffuse large B-cell lymphoma, and Richters transformation. This study includes Phase 1 dose finding and safety expansion, followed by Phase 2 expansion cohorts to determine recommended doses and further assess safety and efficacy. The study is divided into several parts, starting with Phase 1 dose escalation to find safe dosage levels, including monotherapy dose escalation and safety expansion in selected doses. Phase 2 involves expansion cohorts where participants receive the recommended doses identified in Phase 1 for further safety and efficacy evaluation. Some cohorts include participants who have not received prior BTK inhibitors, and Japanese participants are also enrolled to assess safety. Treatments are orally administered. Participants will undergo regular assessments including monitoring for adverse events, disease response, and drug concentration levels in the blood at various time points. Researchers will measure outcomes such as overall response rate and progression-free survival over approximately three years. Safety and tolerability will be closely tracked, and quality of life questionnaires will be completed at scheduled intervals. Participation may last several years, including follow-up periods to monitor long-term effects.

Researchers are evaluating the effectiveness and safety of adding Orelabrutinib to a standard treatment of bendamustine plus rituximab in patients who have not previously been treated for mantle cell lymphoma MCL. This phase 3, randomized, double-blind study aims to compare the combination of Orelabrutinib with bendamustine and rituximab versus bendamustine and rituximab alone. The study is sponsored by InnoCare Pharma Inc. and focuses on patients with treatment-naive MCL, typically older adults. Participants will be randomly assigned to one of two groups one receiving Orelabrutinib orally along with bendamustine and rituximab injections, and the other receiving a placebo oral treatment with bendamustine and rituximab injections. Treatment will continue until the disease progresses or other reasons require stopping. The study uses a quadruple masking design, ensuring that participants and researchers do not know who is receiving Orelabrutinib or placebo. Throughout the study, participants will be monitored for dose-limiting toxicity within the first 28 days and followed for progression-free survival over approximately seven years. Researchers will conduct assessments to track disease status, side effects, and overall health. The trial involves regular visits, laboratory tests, and imaging to evaluate treatment effects and safety. Participants involvement may last several years, including long-term follow-up to understand treatment outcomes and risks.

Researchers are investigating new medicines for children and young people up to 25 years old with relapsed or refractory B-cell non-Hodgkin Lymphoma B-NHL, a type of cancer affecting lymph nodes and organs like the liver or spleen. This international adaptive trial aims to find safer and more effective treatments, focusing on three groups receiving different novel therapies. The study uses a design that allows adding or removing treatments based on their effectiveness and safety in this rare cancer. Participants will receive one of three treatments odronextamab given by intravenous infusion weekly and then less frequently over up to two years loncastuximab tesirine combined with modified R-ICE chemotherapy for up to three cycles or CAR T-cell therapy with details to be confirmed. These treatments are tested in parallel groups, and if a medicine appears ineffective, it may be stopped and replaced by another. The trial allows children to switch groups if their cancer does not respond. During the study, researchers will monitor participants through regular assessments including imaging and laboratory tests to evaluate cancer response and side effects. They will check treatment responses at specific times during treatment cycles and follow patients for at least two years after treatment to monitor long-term outcomes and safety. This includes tracking survival times, adverse events, and overall treatment effectiveness to provide important information about these new therapies.

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

Researchers are studying the use of unlicensed cryopreserved cord blood units CBUs for transplantation in both children and adults with blood cancers and other related disorders. This observational study involves patients with hematologic malignancies and various inherited and acquired disorders affecting the blood and immune system. The main goal is to monitor how well neutrophil recovery occurs after transplantation using these unlicensed CBUs in multiple institutions. Participants receive unlicensed cryopreserved CBUs as part of their transplant treatment. The study includes patients of any age receiving these CBUs for approved indications. The protocol focuses on the access and distribution of these unlicensed units rather than a specific treatment intervention. The study gathers data from recipients who receive these CBUs, tracking outcomes after transplantation. Participants are monitored for neutrophil recovery at 60 and 100 days after transplant, defined by a neutrophil count of at least 500mm3. Researchers also collect information on infection transmission, infusion reactions, survival rates at one year, and incidence of acute and chronic graft versus host disease. Platelet recovery is also evaluated. Safety and efficacy outcomes are followed over time to better understand the effects of unlicensed CBUs in this patient population.

Researchers are evaluating whether maintenance therapy with Zanubrutinib alone can improve the two-year progression-free survival for patients with mantle cell lymphoma who have achieved remission after first-line immunochemotherapy. This study is a multicenter, prospective, phase II trial focusing on patients in remission, aiming to explore the effectiveness and safety of Zanubrutinib maintenance treatment. Patients who achieved complete or partial remission after initial immunochemotherapy, including regimens like R-CHOP or BR, will receive Zanubrutinib monotherapy for up to two years. Treatment will continue until disease progression, intolerable side effects, death, withdrawal, or study termination. This approach allows researchers to assess Zanubrutinib as a maintenance therapy in this patient population. Participants will be monitored over two years, with assessments including progression-free survival, event-free survival, overall survival, toxicity evaluations, and quality of life questionnaires. The study will collect data on blood counts, liver and kidney function, heart function, and coagulation status to ensure safety. The total participation duration may last up to two years, with regular follow-up and safety monitoring throughout the trial period.

Researchers are evaluating whether telehealth music therapy can be a practical treatment for cognitive difficulties in adults who have survived blood cancers such as lymphoma, leukemia, or myeloma. The study also examines if music therapy and music education can help improve cognitive function as well as symptoms like anxiety, depression, and fatigue in this population. This pilot trial is exploring these effects in hematologic cancer survivors who experience cancer-related cognitive dysfunction. Participants will be assigned to one of three groups the experimental music therapy MT group, the therapist-attention music education TAME control group, or a wait-list control WLC group receiving usual care. Those in the MT and TAME groups will receive 12 weekly 60-minute sessions, with homework assignments between sessions to reinforce skills and concepts. The WLC group completes assessments during a 24-week wait period and can later choose to receive either the MT or TAME intervention. During the study, participants will complete assessments to measure the feasibility of telehealth music therapy, defined by completing at least 9 of the 12 sessions. Researchers will monitor cognitive function, mood symptoms, and fatigue. Participants must be able to complete study assessments independently and consent in English. The total study duration includes the intervention period and follow-up assessments to evaluate outcomes related to cancer-related cognitive dysfunction.