Hairy Cell Leukemia

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 investigating a new combination of three drugs—azacitidine, venetoclax, and tagraxofusp—to treat patients with Acute Myeloid Leukemia (AML) who have leftover leukemia cells that cannot be seen with the naked eye. This Phase 1/2 clinical trial aims to assess the safety and how well this drug combination controls residual AML and prevents the disease from coming back. The study builds on FDA approvals of venetoclax and azacitidine together for AML and tagraxofusp alone for another leukemia type, but this combination is not yet FDA-approved for AML treatment. The study involves two groups of participants. In Phase 1, up to 12 people receive escalating doses of tagraxofusp combined with fixed doses of azacitidine and venetoclax to find the safest and best dose. Treatment cycles last 28 days, with azacitidine given daily for seven days, tagraxofusp infused on days 4 to 6, and venetoclax taken on days 1 and 14. In Phase 2, 19 participants receive the recommended dose of tagraxofusp plus azacitidine and venetoclax with the same schedule. Bone marrow biopsies and aspirations occur regularly during treatment to monitor response. After treatment, participants are followed for up to two years. Participants will have regular visits including blood tests, imaging scans like CT, MRI, or PET, heart function tests, and bone marrow examinations. Researchers will monitor for side effects, measure disease remission, and check for minimal residual disease to evaluate treatment impact. The study expects to last about four years with around 31 participants. Outcomes such as remission duration, survival, relapse rates, and safety events will be assessed during treatment and follow-up.

This research aims to understand how well routine childhood vaccinations protect pediatric patients under 21 years old who have been treated for B-cell Acute Lymphoblastic Leukemia or Lymphoma (B-ALL/Ly), especially those who have received the immunotherapy drug blinatumomab. The study compares patients treated with blinatumomab to those who have not, to see if immunotherapy affects the lasting protection from vaccines. It also seeks to establish clear vaccination guidelines for these patients, since chemotherapy and immunotherapy may weaken their immune defenses. Participants are observed in two groups: those who have received blinatumomab and those who have not. The study evaluates whether patients maintain protective antibody levels at least six months after completing blinatumomab therapy. For patients with low immunity, the study will assess if revaccination restores protective antibody levels within six months. The study does not involve new treatments but monitors immune responses over time to routine vaccinations. During the study, participants will have blood tests to measure their antibody levels against common vaccine-preventable diseases. Researchers will track who maintains immunity and who responds to revaccination. The primary measurement is the proportion of patients with protective antibody levels six months post-treatment. The study will continue to monitor participants' immune status and response to boosters, helping to inform future vaccination protocols. Participation may last through follow-up visits over several months after therapy completion.

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.

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.

Researchers are studying the safety, tolerability, and preliminary effects of CG009301 for injection in adults with relapsed or refractory blood cancers, including acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (HR-MDS), and acute lymphoblastic leukemia (ALL). This Phase 1, open-label trial aims to find the best dose and dosing schedule for CG009301 and to better understand its safety profile in participants who have limited treatment options. Participants will receive CG009301 through an intravenous infusion diluted in sodium chloride daily for 7 days per 28-day cycle. The study has two phases: a dose-escalation phase for various relapsed or refractory blood cancers, followed by a dose-expansion phase focusing on AML, HR-MDS, and ALL. Treatment continues until the disease progresses. During the trial, participants will undergo regular assessments including safety monitoring, laboratory tests, and evaluations of drug levels in the body. Researchers will measure outcomes such as the recommended dose for expansion, duration of treatment cycles, adverse events, and clinical responses over periods up to 20 months or longer. Participants are expected to comply with scheduled visits and tests throughout the study duration.

Researchers are evaluating IM-1021, an antibody-drug conjugate, in participants with advanced cancers including B-cell lymphomas and solid tumors. This Phase 1 open-label study aims to assess the safety, tolerability, pharmacokinetics, and early anti-tumor effects of IM-1021. The study includes a dose escalation phase to find safe doses and schedules, followed by an expansion phase to further assess these doses in specific cancer types. IM-1021 is given intravenously on a 21-day cycle, starting at 2 mg/kg, with alternative dosing schedules possible. The study has two parts: Part A focuses on escalating doses to evaluate safety and determine recommended doses, while Part B expands treatment in groups with specific cancer types to further evaluate safety and preliminary activity. Participants will undergo regular safety assessments including monitoring for treatment-related side effects from the first dose through 37 days after the last dose. Researchers will also measure drug levels in the body and evaluate anti-tumor activity starting at week 6 until disease progression or study discontinuation. The total study duration varies per participant. Safety, tolerability, and pharmacokinetic data will guide future development of IM-1021.

Researchers are studying JV-213, a new type of autologous CAR T cell therapy targeting CD79b, in adults with relapsed or refractory B-cell lymphomas. This phase 1 trial aims to find the highest dose of JV-213 that can be safely given to patients who have not responded to previous treatments. The study also explores how well the treatment works and how it affects the body, including how the immune cells behave and potential biomarkers linked to response and side effects. Participants will receive JV-213 through an intravenous (IV) infusion after their own T cells are collected via leukapheresis. The trial has two parts: a dose escalation phase where small groups receive increasing doses to find the maximum tolerated dose, and a dose expansion phase where more participants receive the recommended dose identified in the first part. Each group includes 3 to 6 patients, and dosing is adjusted based on safety observations. During the study, participants will be monitored closely for side effects using standard criteria and evaluated for tumor response and symptom relief. Researchers will collect blood and tumor samples to study the treatment’s effects and track patient health over about one year. Safety, tumor response rates, duration of response, progression-free survival, and overall survival will be measured throughout the trial.

Researchers are evaluating the safety and early effectiveness of TT-01488, an oral tablet that reversibly inhibits BTK, in adults with B-cell malignancies who have not responded to or tolerated previous treatments. This open-label Phase I study aims to find a suitable dose for further testing and to assess how the drug behaves in the body. The study is sponsored by TransThera Sciences (Nanjing), Inc. The trial has two parts: a dose escalation phase where TT-01488 tablets are given once daily in 28-day cycles at increasing doses to find the recommended dose for expansion; followed by a dose expansion phase where this dose is further tested for safety and early effectiveness. The dose escalation uses a modified 3+3 design starting at 50 mg daily, with the goal of identifying a recommended Phase II dose based on safety, drug levels, and response. Participants will take daily tablets and undergo assessments including monitoring for dose-limiting toxicities within 28 days of the first dose, along with safety and response evaluations over three years. Researchers will track adverse events, drug concentration in the blood, and measures like disease control and survival. The study is non-randomized and open-label, and participant involvement may last up to three years depending on outcomes and follow-up needs.

Researchers are evaluating the safety and effectiveness of a new type of gene-modified T cell therapy called 4SCAR19 for patients with B cell malignancies that have returned or not responded to standard treatments. This phase I/II trial involves multiple clinical centers and aims to study both clinical responses and the development of a standardized process to produce these modified cells. The therapy uses a fourth-generation chimeric antigen receptor (CAR) that targets CD19 on cancer cells and includes safety features to control immune responses. The treatment process involves collecting a patient’s blood cells through apheresis, activating and modifying their T cells with the 4SCAR19 gene using a lentiviral vector, and then infusing these engineered cells back into the patient. Before infusion, patients receive a chemotherapy-based conditioning regimen with cyclophosphamide and fludarabine to prepare their immune system. The cell preparation takes approximately 5 to 7 days, and the modified cells are infused following the conditioning treatment. Participants will be closely monitored for safety and treatment responses, including tracking the presence of CAR T cells in their blood over time. Safety is assessed using standard criteria for adverse events over 24 weeks, while tumor response is followed for up to one year. Throughout the study, patients undergo clinical evaluations and laboratory tests to measure outcomes and monitor for any side effects. The trial is expected to continue until the end of 2029.