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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. The study compares two treatment combinations to see if more people respond to zilovertamab vedotin MK-2140 plus R-CHP versus polatuzumab vedotin plus R-CHP. This Phase 2 trial aims to assess the effectiveness and safety of these regimens in participants with newly diagnosed GCB DLBCL. Participants receive either zilovertamab vedotin along with rituximab, cyclophosphamide, doxorubicin, and prednisone R-CHP, or polatuzumab vedotin combined with R-CHP. Treatments are given by intravenous infusion on Day 1 of each 3-week cycle for up to 6 cycles, approximately 4 months, with prednisone or prednisolone taken orally for 5 days of each cycle. For participants with high-risk DLBCL, up to 2 additional cycles of rituximab or biosimilar are given. During the study, participants are monitored for response to treatment using Lugano Response Criteria, with follow-up lasting up to about 31 months for the primary outcome. Secondary outcomes include progression-free survival, overall survival, event-free survival, duration of complete response, adverse events, and quality of life assessments. Safety and health status are regularly checked through exams, lab tests, and questionnaires over several years, with total study participation extending up to 7 years.

Age: 18Years +All GendersPhase 2
140 locations
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Actively Recruiting

Researchers are evaluating ELVN-001, an investigational drug, in adults with chronic myeloid leukemia CML, including those with a specific T315I mutation. This early-phase trial aims to find safe and tolerable doses for further study, especially in patients who have relapsed, are resistant, or cannot tolerate current tyrosine kinase inhibitors TKIs. The study also examines how ELVN-001 affects disease markers and its overall safety profile. The trial includes a dose escalation phase to identify recommended doses, followed by dose expansion phases that treat patients with or without the T315I mutation at those doses. ELVN-001 is given orally once or twice daily. Participants receive the drug as a single agent, and the study monitors responses and safety during these phases. Participants will undergo regular assessments including monitoring for side effects, laboratory tests, heart evaluations, and measurement of molecular responses related to CML over periods ranging from 28 days up to 3 years. The study tracks drug levels in the body for up to 6 months and evaluates long-term outcomes such as complete blood responses. Overall participation duration varies, with close safety follow-up throughout.

Age: 18Years +All GendersPhase 1
45 locations
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Actively Recruiting

Researchers are evaluating the effects and safety of efgartigimod given intravenously in adults with primary immune thrombocytopenia ITP, a condition where the immune system attacks platelets. This phase 3 clinical trial aims to determine how well efgartigimod controls platelet counts compared to a placebo during a 24-week double-blinded treatment period. The study is sponsored by argenx and includes follow-up periods to monitor ongoing effects and safety. Participants will be randomly assigned in a 21 ratio to receive either efgartigimod IV or placebo IV during the double-blinded treatment period. After this, all participants will receive efgartigimod IV during a first 52-week open-label treatment phase, followed by an optional second 52-week open-label phase. After completing these treatment periods, participants will have an approximately 8-week follow-up while off the study drug, with total study participation lasting up to 138 weeks. During the study, participants will have regular blood tests to measure platelet counts and assess disease control. Researchers will track the number of weeks participants maintain platelet counts above specified levels and monitor any bleeding events or adverse effects. Safety is closely observed throughout the trial, including antibody responses to the drug. Participants will have scheduled visits and assessments throughout treatment and follow-up to gather comprehensive data on efgartigimods impact.

Age: 18Years +All GendersPhase 3
94 locations
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Actively Recruiting

Researchers are evaluating the safety, effectiveness, and clinical outcomes of percutaneous coronary intervention PCI for chronic total occlusions CTO in patients treated in routine clinical practice in Poland. The study seeks to understand procedural success rates, complications, and how different PCI strategies, intravascular imaging, mechanical support, and artificial intelligence analysis impact patient outcomes and quality of life. It also focuses on outcomes in various patient subgroups, including those with complex medical histories. This observational study enrolls patients undergoing CTO PCI as part of their standard care in a national, multicenter registry. Clinical, procedural, and follow-up data are collected prospectively to assess real-world outcomes. The study compares PCI performed with and without intravascular imaging and evaluates different treatment strategies such as drug-coated balloons, drug-eluting stents, and hybrid approaches. It also monitors the use of mechanical circulatory support and applies AI-based analysis of baseline electrocardiograms for outcome prediction. Participants will be followed to measure technical success of the procedure and monitor procedural details such as procedure time, fluoroscopy time, radiation dose, contrast volume, and procedural complications within one day. Additional outcomes include target lesion failure during hospital stay and up to one year, as well as mortality at one year. The study collects information on post-procedure cardiac injury markers and quality-of-life improvements, with data gathered throughout routine clinical care over the follow-up period.

Age: 18Years +All Genders
21 locations
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Actively Recruiting

Researchers are studying whether adding navtemadlin to ruxolitinib treatment can provide more benefit than ruxolitinib alone for adults with Myelofibrosis who have not responded well to ruxolitinib by itself. This Phase 3 trial includes patients who are new to JAK inhibitor treatment and have a confirmed diagnosis of primary or post-polycythemia vera or post-essential thrombocythemia Myelofibrosis. The study aims to assess improvements in spleen size and symptom reduction over 24 weeks, as well as long-term outcomes like disease progression and overall survival. Participants first receive ruxolitinib alone during a run-in period to identify those with suboptimal response. Those qualifying are randomly assigned in a 21 ratio to receive either navtemadlin or a placebo as an add-on to their ongoing ruxolitinib. Navtemadlin or placebo is taken orally once daily for 7 days followed by 21 days off in 28-day cycles, while ruxolitinib is taken twice daily continuously. The study is double-blinded so neither participants nor researchers know which add-on treatment is given. During the trial, participants will undergo evaluations including spleen volume measurements and symptom assessments at 24 weeks. They will be monitored for disease progression and survival for up to 8 years. The study includes regular check-ups to track side effects, treatment adherence, and overall health status. These detailed assessments help researchers understand the potential benefits and safety of adding navtemadlin for patients with Myelofibrosis.

Age: 18Years +All GendersPhase 3
215 locations