Hodgkin 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.

Many children with cancer experience emotional distress, fatigue, and difficulties in relationships. Their parents also face increased responsibilities and may feel more distressed and tired. While psychological interventions for these families have shown promise in improving social skills, coping, and well-being, further research is needed. Hypnosis is commonly used in pediatric oncology to reduce pain and distress during procedures and has also been effective in enhancing well-being in adults with cancer. This trial explores the feasibility and potential benefits of combining self-care and hypnosis in a group setting for children with cancer and their parents. The intervention involves six monthly group sessions, each lasting two hours, where participants learn self-hypnosis exercises and discuss self-care techniques like understanding personal needs, self-respect, assertiveness, and managing negative thoughts. Homework assignments are given to encourage positive changes. Two groups participate: one including children with cancer and their siblings, and another for their parents. Data are collected before and after the intervention through questionnaires and interviews to assess its impact. Participants will complete assessments measuring changes in children's quality of life, fatigue related to cancer, and parents' perceptions of their child's quality of life and their own fatigue. Secondary outcomes include the impact of cancer on the family, parents' emotional distress, and coping strategies. These are evaluated before the program starts and immediately after its conclusion at six months. The study aims to improve understanding of how this combined self-care and hypnosis intervention may enhance the well-being of children with cancer and their families.

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.

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.

Sleep plays a vital role in a child's development, affecting brain function, emotional health, and overall recovery. Children undergoing intensive cancer treatments often experience sleep problems such as difficulty falling or staying asleep, shorter sleep duration, or poor sleep quality. These issues, reported in a significant portion of pediatric cancer survivors, can impact treatment adherence, daily life, and social interactions, highlighting the need for better sleep management in this group. Researchers are evaluating the Dreamcatchers Programme, a nurse-led, multi-component intervention designed to improve sleep quality in children with cancer. The program involves sleep hygiene education, progressive muscle relaxation (PMR), and breathing exercises, delivered through group sessions and weekly follow-ups over four weeks. The intervention group receives these targeted strategies, while the control group continues routine hospital support without sleep-specific content, with access to the program after the study. Participants will attend initial education sessions, practice relaxation techniques, and keep sleep diaries to track habits and progress. Nurses will monitor sleep quality and overall life quality at three months using validated tools. Data will be collected securely and confidentiality maintained. This pilot study aims to assess feasibility and provide preliminary effectiveness results to guide future pediatric oncology sleep care.

Researchers are evaluating CTX-8371 in a Phase 1, open-label study involving patients with advanced cancers that are metastatic or locally advanced and have not responded to standard treatments. The study aims to assess the safety, tolerability, immune response, and how the body processes CTX-8371, as well as its preliminary anti-tumor effects. The research is organized into two groups: Dose Escalation and Dose Expansion cohorts. In the Dose Escalation group, patients receive increasing doses of CTX-8371 through intravenous infusions every two weeks, with doses ranging from 0.1 to 10.0 mg/kg. The Dose Expansion group receives fixed doses of either 3.0 mg/kg or 10.0 mg/kg, also administered intravenously every two weeks. Different tumor types such as non-small cell lung cancer, triple-negative breast cancer, and Hodgkin lymphoma are included in the Dose Expansion group. Participants will undergo regular safety and response evaluations including blood tests, imaging, and physical exams over an average follow-up of six months to two years depending on cohort. Researchers monitor tumor response, survival, and how the drug is processed in the body. Safety is tracked from the first dose until 30 days after the last dose. Participants will be closely followed for side effects, immune response, and treatment effects throughout the study period.

Researchers are evaluating the safety, tolerability, and maximum tolerated dose of BPI-371153, a PD-L1 inhibitor, in patients with advanced solid tumors or relapsed/refractory lymphoma. This phase 1 open-label study aims to establish the recommended dose for further research and to understand how the drug behaves in the body and its anti-tumor activity. Participants will receive oral capsules of BPI-371153 once daily in 21-day treatment cycles. The study includes a dose escalation phase to find the maximum tolerated dose and a dose expansion phase where patients receive the recommended dose. Different patient groups include those with advanced non-small cell lung cancer, relapsed or refractory lymphoma, hepatocellular carcinoma, and other advanced solid tumors. During the study, participants will be monitored for adverse events, drug levels in the body, and tumor response over approximately 24 months. Researchers will assess tumor lesions using recognized criteria and evaluate PD-L1 expression levels. The study requires adequate organ function and performance status, with ongoing evaluation to ensure safety and determine the best dose for future studies.

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.