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Found 6 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the effectiveness of satralizumab compared to a placebo in treating Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD). This Phase III study focuses on the time from randomization to the first confirmed MOGAD relapse during the double-blind treatment period. Participants who experience a relapse or complete the double-blind phase may continue into an open-label extension period, with additional adolescents possibly joining the extension after the primary clinical cutoff. The study involves administering satralizumab or placebo by subcutaneous injection in the abdominal or femoral area during site visits after completing other study procedures. Treatment is given as either monotherapy or alongside baseline therapy. Participants remain in the double-blind phase until relapse or study completion, after which they may enter the open-label extension to continue receiving satralizumab. During the study, participants undergo regular assessments to monitor for relapses, including evaluations by an adjudication committee. Researchers measure the time to first MOGAD relapse while also monitoring safety, pharmacokinetics, and pharmacodynamics. The study includes ongoing follow-up and safety monitoring for up to approximately 44 months from randomization, ensuring comprehensive evaluation of the treatment's impact.

Age: 12Years +All GendersPhase 3
82 locations
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Actively Recruiting

Researchers are conducting a multinational clinical trial called LBL 2018 to study treatment approaches for children and adolescents newly diagnosed with lymphoblastic lymphoma. The trial aims to see if replacing prednisone with dexamethasone in induction therapy can reduce relapse involving the central nervous system (CNS) and if intensified treatment improves event-free survival in high-risk patients. Participants are grouped into high risk and standard risk categories based on disease characteristics to guide treatment and randomization. The study compares standard chemotherapy treatment using prednisone to an experimental approach using dexamethasone during induction. Patients in standard risk groups receive induction, consolidation, extra-compartment phases, reintensification (for some), and maintenance therapy over 24 months. High-risk patients can be randomized again after induction to receive either standard or intensified chemotherapy including additional PEG asparaginase and alternating high-risk courses. Patients with CNS involvement receive intensified intrathecal therapy and additional doses during maintenance without cranial irradiation. Participants undergo treatment phases lasting up to 24 months with follow-up for up to 7.25 years to monitor relapse rates and event-free survival. Evaluations include disease status, CNS involvement, and response to therapy. The trial collects pathology and genetic samples for risk stratification and monitors safety and treatment effects across multiple international centers. This comprehensive study seeks to improve outcomes while reducing CNS relapses in young patients with lymphoblastic lymphoma.

Age: 0 - 18YearsAll GendersPhase 3
228 locations
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Actively Recruiting

Researchers are collecting clinical data and biological samples from children and adults diagnosed with rare brain tumors such as medulloblastoma, ependymoma, pineal tumors, and choroid plexus tumors. This international registry, known as the I-HIT-MED, includes patients from Germany and other countries that meet ethical requirements. The goal is to improve understanding of these rare diseases and support better treatment recommendations and counseling through international cooperation. Participants in the registry contribute data including tumor characteristics from neuroradiology, pathology, and molecular biology, alongside details of their standard treatments. Biological specimens such as tumor tissue, cerebrospinal fluid, and blood may also be collected to study disease causes, factors affecting treatment response and survival, and potential targets for new therapies. The registry also evaluates quality assurance systems used in diagnosing and treating brain tumors. During the study, researchers will follow patients over time to monitor clinical courses, long-term outcomes, quality of survival, and neuropsychological effects. The data collected supports patient-centered research and collaboration with external partners. The registry includes patients diagnosed since January 1, 2012, and tracks event-free survival over 10 years, aiming to advance care and knowledge in these uncommon tumor types.

All Genders
57 locations
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Actively Recruiting

This research aims to explore the effects of music therapy on children with cancer and their families, focusing on improving parent-child interactions within a family setting. The study is a randomized controlled pilot trial evaluating how music therapy may enhance mutual attunement, nonverbal communication, and emotional parental responses, while also assessing impacts on quality of life and psychosocial and psychosomatic health. The study addresses a need for more clinical research on family interaction processes through music therapy in pediatric oncology. Participants are assigned to one of three groups: the first group receives interaction-focused music therapy involving both the child and significant family members; the second group receives music therapy involving only the child; and the third group is a waiting group that will receive the intervention after 10 weeks. All music therapy sessions are conducted by trained music therapists, focusing on the parent-child dyad or the child alone as applicable. Throughout the study, parent-child interaction is assessed before and during the 10th hour of intervention using a specialized music therapy assessment (APCI). Secondary outcomes, including quality of life and psychosocial measures, are evaluated using self-report questionnaires at multiple time points: before, after, and during follow-up. The study monitors the psychosocial functioning of the family system and hopes to provide evidence to support tailored family-centered care for children with cancer.

Age: 5Years - 13YearsAll GendersPhase Not Applicable
3 locations
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Actively Recruiting

Researchers are studying pre- and perimenopausal women with estrogen- and/or progesterone-receptor-positive, HER2-negative early breast cancer who have an intermediate to high clinical risk but low genomic risk of recurrence based on MammaPrint4 testing. The study aims to understand the real-world use of ovarian function suppression (OFS) combined with endocrine therapy, with or without prior chemotherapy, and how secondary amenorrhea after chemotherapy might affect outcomes. It also focuses on treatment adherence and quality of life over time, given the importance of long-term endocrine treatment up to 10 years. The registry will follow patients receiving standard-of-care treatment, which may include endocrine therapy with or without ovarian function suppression, and potentially chemotherapy based on clinical decisions. Data on treatment choices, including the use of OFS and chemotherapy, will be collected along with tumor characteristics assessed by local pathology and genomic signatures. Quality of life assessments will be conducted at baseline and multiple time points up to five years, while treatment adherence and outcomes will be tracked over up to 10 years. Participants will provide baseline information including tumor and treatment details. Researchers will collect follow-up data on treatment adherence, quality of life using specific questionnaires, and disease outcomes such as the five-year distant recurrence-free interval. Monitoring will include hormonal status and clinical assessments to correlate treatment effects with genomic risk scores and clinical markers. The overall goal is to improve understanding of treatment patterns and outcomes in this specific breast cancer population under real-world conditions.

Age: 18Years - 60YearsFEMALE
71 locations
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Actively Recruiting

Researchers are studying acute lymphoblastic leukemia (ALL) in children and adolescents to improve treatment approaches. Recent genetic research shows ALL is a varied disease with different underlying mechanisms. This trial focuses on using new prognostic markers for better risk assessment and tests immunotherapy with the bispecific antibody blinatumomab as an alternative to some intensive chemotherapy in certain patients. It also evaluates the proteasome inhibitor bortezomib for patients with slow chemotherapy response and explores intensified consolidation chemotherapy in T-cell ALL patients to reduce relapse risk. Participants are assigned to risk groups based on leukemia type, genetics, and treatment response. The study tests four main questions through different randomizations comparing standard chemotherapy with added treatments: bortezomib during extended consolidation for early high-risk precursor B-cell ALL; blinatumomab immunotherapy replacing intensive chemotherapy courses for high-risk precursor B-cell ALL; blinatumomab after reintensification chemotherapy for intermediate-risk precursor B-cell ALL; and a longer, intensified consolidation phase for certain T-cell ALL patients. Some very high-risk patients may receive stem cell transplantation, and specific patients may get cranial irradiation. During the study, participants undergo comprehensive evaluations including genetic testing, bone marrow assessments, and minimal residual disease monitoring. Researchers track event-free survival and disease-free survival for up to 10 years from study start. They also monitor treatment safety, side effects, and overall survival. The trial enrolls patients under 18 years old recently diagnosed with ALL or related leukemias and follows individualized treatment plans based on risk and response.

Age: 0 - 17YearsAll GendersPhase 3
115 locations
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