Mantle Cell Lymphoma

Researchers are studying the use of 3'-deoxy-3'-[18F] fluorothymidine (FLT) positron emission tomography (PET) imaging in patients with cancer. This phase I trial aims to evaluate how well FLT PET imaging measures tumor growth and the activity of the DNA synthetic pathway in various cancers, including solid tumors and blood cancers. The study also seeks to determine how effective this imaging method is at detecting lesions and assessing response to treatment. Participants receive up to four FLT PET imaging procedures. During each procedure, a small amount of the FLT tracer compound is injected into the vein, followed by PET scan data collection for two hours to measure tumor growth. Blood samples may be taken during the scans, and urine samples collected afterward to analyze breakdown products of the tracer. Throughout the study, patients undergo assessments including PET or CT PET scans to measure tracer uptake and retention in tumors and normal organs. Researchers also evaluate changes in key enzymes related to DNA synthesis before and after therapy. These evaluations help monitor tumor activity and treatment response. The total time participants spend in the scanner during imaging is up to two hours per session, with a focus on capturing detailed tumor growth information.

Researchers are evaluating a new universal CAR T cell therapy called 4SCAR19U for patients with CD19-positive B cell malignancies. This phase I trial aims to assess the feasibility, safety, and effectiveness of these specially engineered T cells. The study also seeks to understand how well the 4SCAR19U T cells function and how long they remain active in patients. This approach may offer a faster, more cost-effective alternative to traditional CAR T therapies, especially for patients with weakened immune systems or rapidly progressing disease. The treatment involves infusing patients with universal CD19-specific CAR gene-engineered T cells known as 4SCAR19U cells. These cells are manufactured in bulk and ready to use off-the-shelf, avoiding the long preparation time required for patient-specific therapies. This immediate availability aims to provide timely treatment to patients who need it urgently. The trial is conducted at multiple clinical centers and includes one experimental group receiving the 4SCAR19U cell infusion. Participants will be monitored closely for safety over 24 weeks following the infusion, with evaluations of adverse effects and overall health. The study will also track the anti-tumor activity of the 4SCAR19U cells for up to one year after treatment. Assessments include physical exams, blood tests, and other clinical evaluations to understand the treatment's impact and cell persistence. The total duration of involvement varies, with long-term follow-up to gather important safety and effectiveness data.

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 orally administered Bruton Tyrosine Kinase targeted protein degrader, in adults with various B-cell malignancies including relapsed or refractory forms of marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenstrf6m macroglobulinemia, diffuse large B-cell lymphoma, and Richter's transformation. The study aims to find the recommended dose and assess the safety, tolerability, and response rates in this population through a phase 1/2 open-label trial. The trial includes several parts: a phase 1 monotherapy dose finding with dose escalation and safety expansion, followed by phase 2 expansion cohorts. Participants receive BGB-16673 orally at various dose levels to determine the maximum tolerated dose and the recommended dose for further study. Specific groups include Japanese participants and those who have not previously received a Bruton Tyrosine Kinase inhibitor. Dose escalation and safety data are collected to guide dosing recommendations, with some cohorts focused on particular lymphoma subtypes and treatment histories. Participants will be monitored from the first dose of BGB-16673 until 30 days after the last dose or before starting new anticancer therapies, for up to 47 weeks in phase 1 and approximately three years in phase 2. Assessments include adverse event tracking, response rates, pharmacokinetics, and quality of life questionnaires. Various measures such as plasma drug concentration, protein degradation, and progression-free survival are evaluated periodically. Safety and efficacy data support long-term monitoring and dose adjustments throughout the study period.

Researchers are evaluating the feasibility and safety of combining tazemetostat, an oral medication, with standard CAR T cell therapy in patients with previously treated diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma. The study aims to see if this combination can help CAR T cells better identify and kill lymphoma cells without causing significant safety issues. This is a phase 1, single-arm, open-label trial exploring this new approach. Participants will take 800 mg of tazemetostat pills twice daily starting at least one week before apheresis (a procedure to collect immune cells), continuing until lymphodepleting chemotherapy begins. They will pause tazemetostat during chemotherapy and CAR T cell infusion, then resume once blood counts recover. Depending on the response, tazemetostat treatment may continue for up to 6 months in those with complete responses or up to 12 months in those with partial responses. This treatment plan is investigational and designed to assess feasibility. During the study, participants will be monitored for side effects and treatment responses. Safety will be assessed by recording adverse events from the start of treatment until about 13 months afterward, including specific monitoring for cytokine release syndrome and neurotoxicity up to 21 days post-CAR T infusion. Researchers will also evaluate overall response rates, progression-free survival, and overall survival for up to 6 years. Participants will be followed for up to 5 years in total to understand long-term outcomes.

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.

Researchers are collecting long-term safety and effectiveness data for participants treated with ibrutinib, a first-in-class, orally taken medicine that targets Bruton’s tyrosine kinase. The study focuses on individuals who have already been treated with ibrutinib in prior studies and are continuing to benefit from the treatment. The goal is to provide ongoing access to ibrutinib while monitoring health outcomes over time. Participants will continue taking ibrutinib capsules once daily at the dose established in their previous study (ranging from 140 mg to 560 mg) until the doctor decides the treatment is no longer helping, the participant chooses to stop, or other specified reasons occur. Some participants may receive ibrutinib alone or in combination with nivolumab depending on their prior treatment. The study is open-label, meaning everyone knows the treatment being given. During the study, participants are regularly monitored for safety and disease changes through assessments and visits until they stop the study drug or move to other treatments. Researchers track side effects up to 30 days after the last dose and may analyze how the disease responds in combination with earlier study data. The study continues until all participants transition off study treatment or the sponsor ends the trial, ensuring ongoing care and data collection over time.

Researchers are studying the use of unlicensed cryopreserved cord blood units (CBUs) for transplantation in both pediatric and adult patients with various blood-related cancers and other disorders affecting the blood-forming system. This observational study aims to evaluate outcomes such as the recovery of a certain level of white blood cells after transplantation, as well as the incidence of infections, infusion reactions, survival rates, and graft-versus-host disease over time. The study involves patients receiving unlicensed CBUs at multiple U.S. transplant centers. These CBUs are used for patients with hematologic malignancies and other blood disorders. The protocol collects data on patients who receive these unlicensed transplant units, without administering a new treatment but observing the outcomes after transplantation. Participants will be monitored for neutrophil recovery at 60 and 100 days post-transplant, along with assessments of infection transmission, infusion reactions, survival one year after transplant, and occurrences of acute and chronic graft-versus-host disease. Platelet engraftment levels will also be tracked. The study includes patients of any age and follows them through the transplantation and recovery process to gather information on these key outcomes.