Chronic Lymphocytic Leukemia (CLL)

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 evaluating a new formulation of 64Cu-LLP2A, a drug used with PET/CT imaging, to study its dosimetry and imaging quality in healthy volunteers and patients with certain blood cancers. These cancers include multiple myeloma and various low-grade lymphomas. This early phase 1 study aims to confirm that the new formulation provides similar human dosimetry to previously published results and to expand evaluation to patients with confirmed diagnoses or those post bone marrow transplant with suspected recurrence. Participants will receive 64Cu-LLP2A followed by PET/CT imaging at up to three separate times depending on the injection day of the week. Imaging sessions involve multiple quick body scans within the first hour, additional scans between 120 to 240 minutes, and a later scan 15 to 28 hours post injection. Patients with known lesions will have dynamic imaging centered over those areas for one hour, plus an additional scan from head to upper thigh after injection. During the study, participants will undergo PET/CT scans and monitoring of organ dosimetry and safety for up to seven days after 64Cu-LLP2A administration. Researchers will assess the quality of PET images by looking at bone marrow uptake and tumor-to-background ratios. Safety will be tracked by recording any adverse events. The total imaging and evaluation period is estimated to last up to two days, with additional follow-up phone assessments.

Researchers are evaluating the safety and effectiveness of GT801 injection in adult patients with relapsed or refractory CD19-positive B-cell blood cancers and autoimmune hemolytic anemia. This early phase 1 clinical study focuses on patients with B-cell acute lymphoblastic leukemia, chronic lymphocytic leukemia, B-cell non-Hodgkin's lymphoma, and autoimmune hemolytic anemia who have experienced disease progression after at least second-line drug treatments. The study includes an interim analysis after two patients complete the primary endpoint measurement. Participants will receive GT801 injection as the experimental treatment. The study monitors the proportion of participants experiencing dose-limiting toxicities within 28 days and tracks adverse events for three months after infusion. Additionally, secondary outcomes such as overall response rates, duration of response, progression-free survival, and overall survival up to 12 months post-infusion are assessed for hematologic malignancies. For autoimmune hemolytic anemia, response rates, disease-free recurrence, and time to response are also measured over 12 months. During the study, participants will be closely monitored through clinical assessments and safety evaluations, including adverse event tracking for three months and disease response assessments for up to one year. The study requires participants to meet specific eligibility criteria, including confirmed CD19 positivity and prior treatment history. Follow-up evaluations will ensure ongoing safety and measure treatment outcomes, with participation lasting up to 12 months after GT801 infusion.

Researchers are evaluating SCTC21C, a biological treatment, in patients with relapsed or refractory CD38-positive hematologic malignancies. This multicenter, open-label Phase I trial aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary anti-tumor activity, and immune response to SCTC21C. The study includes a dose-finding stage to determine safe dosage levels and a dose-expansion stage to further evaluate selected doses. In the dose-finding stage, participants receive increasing doses of SCTC21C ranging from 0.01 mg up to 960 mg. In the dose-expansion stage, at least 20 participants are randomly assigned in a 1:1 ratio to receive two different doses determined from the earlier stage. SCTC21C is given by subcutaneous injection weekly for the first two cycles, then every two weeks for cycles three to six, and every four weeks thereafter until disease progression or unacceptable side effects occur. Participants will be closely monitored throughout the study with assessments including safety evaluations, adverse event tracking up to 45 days after the last dose, and measuring dose-limiting toxicities during the first 28-day cycle. Researchers will also evaluate tumor response over about one year of treatment. The study expects participants to have regular visits for treatment and monitoring, with the total duration varying depending on individual response and tolerability.

Researchers are evaluating the safety and effectiveness of TQB3909 tablets in adults with recurrent or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This phase Ib/II clinical trial aims to understand how this treatment works in patients whose disease has returned or not responded to previous therapies. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and includes participants aged 18 to 75 years. Participants will take TQB3909 tablets orally once a day at doses of either 400 mg or 600 mg in 28-day treatment cycles. Treatment continues until the disease worsens or unacceptable side effects occur. The trial does not include a placebo group and does not use masking or blinding methods. During the study, researchers will monitor participants for side effects and response to treatment for up to 34 months. They will assess safety through adverse event reporting and laboratory tests, and measure treatment effects by looking at remission rates, disease progression, and survival outcomes. Blood samples will be collected to study drug levels and potential biomarkers. Participants will be followed closely throughout the treatment and observation periods.

This observational study focuses on patients aged 18 and older who have lymphoproliferative disorders, a group of blood cancers affecting the lymphatic system. Researchers aim to understand the overall survival over 10 years for different types of these disorders. The study also examines factors like patient fitness, comorbid conditions, and how these influence treatment choices and outcomes. New therapies including chemo-free protocols, targeted drugs, and cell therapies are being evaluated to determine the best treatment sequences for cases that are refractory or relapsed. Participants will be observed through various phases of their disease, including diagnosis and treatment stages. The study investigates the impact of clinical and biological factors on disease progression or relapse, as well as potential links between genetic profiles and clinical outcomes. It also monitors adverse events like tumor lysis syndrome and their effects on treatment adjustments. Additionally, the study looks at patients managed with a watch-and-wait approach, long-term toxicities, secondary cancers, and healthcare resource use. Throughout the study, participants' health and treatment outcomes will be regularly assessed using clinical data collected from diagnosis through follow-up. Researchers will analyze survival rates, treatment effectiveness, and side effects over a long period from 2002 to 2030. This comprehensive data collection aims to improve understanding of lymphoproliferative disorders and optimize patient management strategies over time.

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 safety and feasibility of using bone marrow transplants from deceased donors in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas. The trial is a first-in-human study that explores how well these transplants work when combined with different conditioning treatments before transplantation. This study is led by Ossium Health, Inc. and includes adult patients who meet specific matching and health criteria. Participants receive one of several pre-transplant conditioning regimens, either myeloablative conditioning (MAC) or reduced intensity conditioning (RIC), involving various combinations of chemotherapy drugs and total body irradiation. After the transplant of Ossium HPC, Marrow, patients receive post-transplant treatments including Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, and Filgrastim. The study has two experimental cohorts and includes close monitoring after transplantation. During the study, patients are monitored closely for safety outcomes such as neutrophil engraftment by day 28 and serious adverse events by day 56, with follow-up continuing for one year. Researchers will assess immune recovery, transplant-related complications like graft-versus-host disease, infections, and disease relapse rates. The total participation includes a safety evaluation period of 56 days and extended follow-up to track longer-term outcomes and survival.

Researchers are evaluating the effectiveness and safety of Lisaftoclax (APG-2575) combined with Acalabrutinib compared to immunochemotherapy in patients newly diagnosed with Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL). This global, multicenter, randomized, open-label Phase III study aims to confirm whether this combination treatment provides benefits over standard immunochemotherapy regimens. The trial is sponsored by Ascentage Pharma Group Inc. and follows guidelines for diagnosis and treatment need according to IWCLL NCI-WG (2018 edition). Participants will be randomly assigned to receive either the experimental treatment—Lisaftoclax taken orally once daily and Acalabrutinib taken orally twice daily in 28-day cycles—or standard immunochemotherapy involving drugs such as Fludarabine, Cyclophosphamide, Rituximab, or Chlorambucil administered every 28 days for six cycles. Treatment duration, dosing schedules, and combinations are carefully monitored throughout the study period. During the study, patients will undergo assessments including measuring progression-free survival up to one year, evaluating response rates, and checking minimal residual disease negativity. Safety will be monitored by recording adverse events during the same period. Participants must complete research procedures and follow-up exams, with the study expected to continue until August 2028. Informed consent and adherence to study procedures are required for all participants.