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Recruiting Phase 1/2

The Safety and Tolerability of LBS-007 in Patients With Relapsed or Resistant Acute Leukaemias

Relapsed or Resistant Acute Leukaemias

The most common types of acute leukaemia are acute lymphoblastic leukaemia (ALL) and acute myeloid leukaemia (AML). AML is a heterogenous clonal disorder of haemopoietic progenitor cells and the most common and severe malignant leukemia in adults and is responsible for the highest mortality from leukemia. ALL is a neoplasm characterized by the growth of malignant lymphoblasts of the B or T lineage, leading to an inhibition of proliferation of the normal blood cell lineages. The primary objectives of this study are investigating the safety, tolerability, and the MTD of LBS-007. The secondary objectives are to assess the efficacy and to determine the pharmacokinetics (PK) of LBS-007. The exploratory objective is to study and correlate the changes in surrogate biomarkers in response to treatment.

Начало: 20.07.2023 Край: 31.12.2026 Възраст: 18–120 г. Treatment

Australia, China, Taiwan +1 Lin BioScience, Inc NCT05756322

Recruiting

Asciminib RMP Study

Chronic Myeloid Leukemia

This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Asciminib in the real-world clinical setting in Korean Chronic myeloid leukemia (CML) patients.

Начало: 19.07.2023 Край: 07.06.2030 Възраст: 18–100 г.

South Korea Novartis Pharmaceuticals NCT05943522

Recruiting Phase 3

Program to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus

Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) is an immune-mediated disease associated with inflammation of multiple organ systems. This study will assess how safe and effective upadacitinib is in treating adult participants with moderately to severely active SLE. Adverse events and change in the disease activity will be assessed. Upadacitinib is an approved drug for rheumatoid arthritis, psoriatic arthritis, and axial spondylarthritis and is being developed for the treatment of SLE. This study is "double-blinded", which means that neither the trial participants nor the study doctors will know who will be given upadacitinib and who will be given placebo (does not contain treatment drug) . This study comprised of 4 sub studies. In Study 1 and Study 2, study doctors put the participants in 1 of the 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Eligible participants from Study 1 and Study 2 will enter Study 3 at week 52 to receive specific doses of upadacitinib. Study 4 is a 104-week continued extension if participation is likely to provide a benefit to their SLE. Approximately 500 participants diagnosed with SLE will be enrolled in each of the Study 1 and Study 2 in approximately 320 sites across the world. Participants will receive oral tablets of upadacitinib or matching placebo once daily for 52 weeks in Study 1 and Study 2. Eligible participants from Study 1 and Study 2 will receive oral tablets of upadacitinib once daily for 52 weeks in Study 3. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

Начало: 19.07.2023 Край: 01.10.2027 Възраст: 18–63 г. Treatment

Argentina, Australia, Belgium +34 AbbVie NCT05843643

Recruiting

Optimizing INtrinsic Capacity for Functional INdependence and to Impede FrailTY in Older Adults: Adaptation of the WHO-ICOPE for Healthy Ageing in Singapore

Frailty in Older Adults Intrinsic Capacity Age-related Functional Decline Healthy Ageing

The goal of this intervention study is to screen and identify frailty and decline in intrinsic capacity (physical and mental capacities) in community-dwelling older adults in Singapore, and to evaluate whether early identification and targeted interventions can improve health outcomes and support healthy ageing. The main questions it aims to answer are: * Can combined frailty and intrinsic capacity screening with targeted interventions prevent or reduce functional decline in older adults, as measured by changes in life space mobility? * Will at least 80% of screened older adults adhere to recommended care pathways and interventions? * Can this screening and intervention programme demonstrate sustainability through continued community participation and recruitment of new partner organizations beyond the initial implementation phase? The investigators will compare an intervention group (receiving immediate assessment and clinical referrals based on identified needs) to a wait-list control group (receiving the same interventions 12 months later) to see if early intervention leads to better health outcomes and quality of life. Participants will: * Attend 4 study visits over 2 years (at 6-monthly intervals in the first year, with final assessment at end of year 2), each lasting up to 2 hours. * Undergo comprehensive screening assessments including mobility, cognition, mental health, hearing, vision, and nutritional status. * Receive 2 follow-up phone calls at 3-month and 9-month intervals to monitor progress. * If in the intervention group: receive personalized referrals for further care (which may include comprehensive geriatric assessment, primary care reviews, rehabilitation, or dietitian consultations) and guidance on using a mobile health monitoring application. * If in the wait-list control group: receive the same interventions after their 3rd study visit (12 months later).

Начало: 17.07.2023 Край: 15.01.2028 Възраст: от 60 г.

Singapore Sengkang General Hospital NCT07477561

Recruiting Phase 1

A Study of PEP07 (Checkpoint Kinase 1 Inhibitor) in Patients With Advanced Cancer

Acute Myeloid Leukemia Lymphoma, Mantle-Cell

The goal of this clinical trial is * To assess the safety and tolerability of PEP07 administered orally as a single dose and at escalating dose levels, and, to determine the dose-limiting toxicity (DLT) of study treatment in patients with Acute Myeloid Leukemia (AML) and Mantle Cell Lymphoma (MCL). * To determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of PEP07 monotherapy. Participants will receive PEP07 administered orally once daily (QD) for 2 consecutive days and 5 days off, every week for 4 weeks until disease progression, intolerable toxicity, confirmed pregnancy, death, consent withdrawal, HSCT or other anti-cancer treatment is required, or the Sponsor ends the study, whichever occurs first.

Начало: 17.07.2023 Край: 31.12.2026 Възраст: от 18 г. Treatment

Australia, Taiwan PharmaEngine NCT05659732

Recruiting Phase 2

Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia

Leukemia

To learn if cyclophosphamide, vincristine, and dexamethasone (called mini hyper-CVD) in combination with intrathecal (delivered into the spine) chemotherapy (methotrexate, hydrocortisone, cytarabine) and compressed rituximab, blinatumomab, and inotuzumab ozogamicin (called cRIB) can help to control the disease.

Начало: 14.07.2023 Край: 31.12.2029 Възраст: 1–25 г.

United States M.D. Anderson Cancer Center NCT05645718

Recruiting

Coping and Attachment in Pediatric Oncohematology

Pediatric Cancer Coping Behavior Relationship, Parent Child

Cancer can be a traumatic and particularly salient experience in a person's history. The ways in which the pediatric patient copes with it depend on the interaction of several factors present in his or her life context, primarily the relationship that is established between parent and child. Despite the paucity of studies in the literature in this regard, it would seem that parental coping is predictive of child coping. Coping strategies represent the ways in which people try to manage traumatic events or stressful everyday situations. Currently, the literature identifies two main categories of coping strategies: emotion-oriented and problem-oriented strategies. The former are aimed on reducing stress-induced unpleasant emotions (e.g., problem avoidance, positive reappraisal, etc.); the latter, on the other hand, focus on stress dissolution/alteration (e.g., problem identification and resolution, stress cause research). Some studies, previously conducted in oncology, show that emotion-focused coping strategies are associated with better adaptation immediately after diagnosis, but their positive influence tends to weaken over time; problem-focused coping strategies are more correlated with poor adaptation immediately after diagnosis, but in the later stages of treatment. The clinical experience with patients in the Pediatric Oncohematology Department brings out the need to develop and structure a psychological assessment model, in order to ensure a more effective care of the family units followed. The research aims, through a single administration of psychological tests, to investigate the role of attachment and some variables (age, gender, stage of treatment, stage of the disease, social support, resilience, ability to adapt to environmental stimuli, emotional state of of caregivers) on the coping strategies implemented by the parents of patients and the patients themselves, in order to differentiate the types of psychological intervention, to try to reduce psychological distress and increase levels of mental well-being.

Начало: 12.07.2023 Край: 31.12.2026 Възраст: 8–17 г.

Italy Fondazione IRCCS Policlinico San Matteo di Pavia NCT06858163

Recruiting Phase 3

Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)

Psychosis Associated With Alzheimer's Disease

This is a Phase 3 global, multicenter, 52-week, open-label extension (OLE) rollover study for subjects completing study CN012-0026, CN012-0027 or CN012-0056. Subjects (randomized or non-randomized) who complete the 38-week CN012-0026 study, 14-week CN012-0027 study or 14-week CN012-0056 study will be eligible to enroll in CN012-0028. The primary objective of the study is to assess the long-term safety and tolerability of KarXT in subjects with psychosis associated with Alzheimer's Disease.

Начало: 11.07.2023 Край: 07.09.2027 Възраст: 55–90 г.

Argentina, Belgium, Brazil +28 Karuna Therapeutics, Inc., a Bristol Myers Squibb compa NCT05980949

Recruiting

Long-Term Follow-Up (LTFU) of Subjects Dosed With NTLA-2001

Transthyretin-Related (ATTR) Familial Amyloid Polyneuropathy Transthyretin-Related (ATTR) Familial Amyloid Cardiomyopathy Wild-Type Transthyretin Cardiac Amyloidosis

This is a follow-up study of subjects who received NTLA-2001 in a previous clinical trial as an observational evaluation of the long-term effects of the investigational therapy.

Начало: 10.07.2023 Край: 01.03.2038 Възраст: от 18 г.

France, New Zealand, Sweden +1 Intellia Therapeutics NCT05697861

Recruiting Phase 3

An Open-label Phase 3 Study of Lutetium (177Lu) Oxodotreotide Injection in Subjects With Advanced Gastrointestinal Pancreatic Neuroendocrine Tumors.

Advanced Gastroenteropancreatic Neuroendocrine Tumor

The study is being conducted to evaluate the efficacy, and safety of Lutetium (177Lu) Oxodotreotide Injection in subjects with advanced gastrointestinal pancreatic neuroendocrine tumors.

Начало: 06.07.2023 Край: 01.10.2030 Възраст: 18–75 г.

China Jiangsu HengRui Medicine Co., Ltd. NCT05884255

Recruiting Phase 1/2

Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors

Head and Neck Squamous Cell Carcinoma (HNSCC) Pancreatic Adenocarcinoma Non-small Cell Lung Cancer (NSCLC) Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC) +2

The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.

Начало: 06.07.2023 Край: 01.05.2028 Възраст: от 18 г.

Belgium, United Kingdom, United States Exscientia AI Ltd., a wholly owned subsidiary of Recurs NCT05985655

Recruiting Phase 2

Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement

Advanced Cholangiocarcinoma FGFR2 Fusions Gene Rearrangement

This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.

Начало: 05.07.2023 Край: 01.12.2026 Възраст: от 18 г. Treatment

Argentina, Australia, Brazil +9 Taiho Oncology, Inc. NCT05727176

Recruiting Phase 3

A Long-term Follow-up Trial of Patients Previously Treated With Imlifidase Prior to Kidney Transplantation and a Non-comparative Transplanted Patient Group

Long Term Efficacy and Safety

A prospective, post-authorisation long-term follow-up trial of patients previously treated with imlifidase prior to kidney transplantation, including a non-comparative concurrent reference cohort.

Начало: 03.07.2023 Край: 30.04.2030 Възраст: 19–76 г.

Austria, Czechia, France +4 Hansa Biopharma AB NCT05937750

Recruiting

PaCIFiC-CUP Classifies Cancer of Unknown Primary

Unknown Primary Tumors DNA Methylation

This study aims to initially utilize machine learning on pan-cancer DNA methylation data from public databases to construct a DNA methylation classification model (PaCIFiC-CUP, pan-cancer integrated fingerprinting classifier of CUP) for diagnosing various types of cancer, particularly the primary site of cancer of unknown primary. The goal is to achieve diagnosis of cancer pathology type by analyzing the DNA methylation patterns of cancer specimens, thereby guiding subsequent precision treatment for cancer.

Начало: 01.07.2023 Край: 31.12.2026 Възраст: 18–80 г.

China Sun Yat-sen University NCT06140992

Recruiting

Improving Prosthetic Provision in Rural Communities: Limb Scanning With Caregiver Assistance

Lower Extremity Amputation

When the prosthetic socket of a Veteran with a lower limb amputation no longer fits or is damaged beyond repair, a new prosthetic socket is warranted. The provision of a new socket requires multiple clinical visits which can place a high travel burden and potential pandemic exposure stress on Veterans who live in rural communities far from VA Medical Centers or alternative prosthetic clinics. This research seeks to determine if one of the in-person visits traditionally needed to obtain a well-fitting prosthesis can be performed remotely with the assistance of a helper. The investigators seek to discover if an untrained individual (a helper) can wield inexpensive, easy to use, digital technology to capture the shape of a residual limb to see if it can be used to fabricate a prosthetic socket that fits at least as well as one fabricated by a prosthetist using traditional, hand casting methods in the clinic. The expected result of this research is an evidence-based prosthetic fabrication process that reduces Veteran travel burden while providing a prosthesis that fits at least as well as the current standard-of-care. The upshot is a clear improvement in prosthetic provision for Veterans, particularly for those who live in rural communities. To make this determination, the investigators will perform a between-subject experiment with two specific aims. To determine differences in goodness of fit between the two study sockets, the investigators will use both patient reported outcomes, and measurements of the pressure applied to the distal end of the residual limb. Specific Aim 1: Determine if patient reported outcomes, by subjects wearing a prosthetic socket whose shape was captured with study helper assistance, are at least as good as those reported by subjects wearing a socket whose shape was captured by a prosthetist. The investigators propose to recruit Veterans with a below knee amputation and their study helpers to participate in a human subject experiment. Participants will be randomly assigned and fit with either a prosthesis made with study helper assistance and digital methods, or one made wholly by a prosthetist using traditional methods. Patient reported outcome metrics will be collected while the subject is still wearing their as-prescribed socket at the beginning of the study (baseline), and again after wearing the study prosthesis for two weeks. Specific Aim 2: Determine if distal end residual limb pressure, measured from a group of individuals fit with a prosthetic socket whose shape was captured with study helper assistance using digital methods, are no worse than those measured from a group of individuals fit with a prosthetic socket whose shape was captured by a prosthetist using traditional methods. Concurrent with the human subject procedures briefly described above, the investigators propose to fabricate duplicates (copies) of the two prosthetic sockets used by each subject in Specific Aim 1. A novel sensor will be embedded in these duplicate sockets which can measure the pressure applied to the distal end of the residual limb. Measurements of distal end residual limb pressure while standing and walking for both the as-prescribed and study sockets will be collected at the beginning of the study (baseline), and again after two weeks. The data from the investigators' experiments will be used to determine if residual limb shape capture by a helper using digital technologies can be used to make prosthetic sockets that fit at least as well as those made by a prosthetist using traditional, hand casting techniques. One third of all Veterans live in rural communities far from VA Medical Centers. When Veterans with a lower limb amputation need a new prosthetic socket, attending in-person clinical visits can be a challenge. If the hypotheses are supported, this research will provide evidence to support the use of digital technology as part of clinical practice, enabling a remote, study helper enabled alternative to one of the in-person clinical visits needed to fabricate a well-fitting prosthesis.

Начало: 01.07.2023 Край: 30.09.2026 Възраст: 18–70 г.

United States VA Office of Research and Development NCT05884203

Recruiting Phase 2

Intrathecal Chemoprophylaxis to Prevent Neurotoxicity Associated With Blinatumomab Therapy for Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia

Changing the schedule of intrathecal chemotherapy to be given before and during blinatumomab will maintain the anti-leukemic effects of this drug while at the same time adding the benefit of limiting the neurotoxicity associated with cytokine release.

Начало: 30.06.2023 Край: 01.12.2026 Възраст: от 18 г.

United States Northside Hospital, Inc. NCT05519579

Recruiting Phase 1

DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors

Advanced or Metastatic Solid Tumors

This is a multicenter, open-label, Phase 1 study to assess the effects of DCSZ11 as a monotherapy and in combination in patients with advanced or metastatic solid tumors. The study consists of an Escalation Phase (Phase 1a) and a Dose Expansion/Optimization Phase (Phase 1b).

Начало: 28.06.2023 Край: 01.12.2026 Възраст: от 18 г. Treatment

Australia, South Korea, Taiwan +1 DynamiCure Biotechnology NCT05785754

Recruiting

Friedreich Ataxia Global Clinical Consortium UNIFIED Natural History Study

Friedreich Ataxia

This project is a global, multicenter, prospective, longitudinal, observational natural history study that can be used to understand the disease progression and support the development of safe and effective drugs and biological products for Friedreich ataxia.

Начало: 28.06.2023 Край: 28.01.2048

Australia, Belgium, Brazil +13 Friedreich's Ataxia Research Alliance NCT06016946

Recruiting Phase 3

ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors

Non Small Cell Lung Cancer

The goal of this Phase 3 clinical trial is to study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.

Начало: 28.06.2023 Край: 31.08.2028 Възраст: от 18 г. Treatment

Australia, Belgium, Canada +9 OncoC4, Inc. NCT05671510

Recruiting Phase 3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease

The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.

Начало: 28.06.2023 Край: 30.06.2027 Възраст: 40–90 г. Treatment

Argentina, Australia, Belgium +34 Hoffmann-La Roche NCT05878769

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