Amman

Diffuse large B-cell lymphoma DLBCL is the most common and aggressive subtype of non-Hodgkin lymphoma, with rapid tumor growth and symptoms varying by tumor location. The disease is classified using advanced methods like immunohistochemistry and molecular testing to guide prognosis and personalized treatment. Despite standard immunochemotherapy curing 60-70% of patients, many experience treatment failure or relapse, and options after second-line therapies remain limited. This observational study examines treatment patterns, demographic, and clinical characteristics of DLBCL patients in the Middle East and Africa. It includes two patient groups those newly diagnosed and eligible for treatment, and those with relapsed or refractory DLBCL who have failed previous therapies. The study aims to explore access to novel therapies and understand real-world treatment approaches in these regions. Participants will be observed over 22 months, during which researchers will document treatment regimens, patient risk profiles, and access to new treatments. Data collection includes patient demographics, disease characteristics, and treatment outcomes. The study does not involve experimental treatments but gathers detailed information to inform future care strategies for DLBCL patients.

Researchers are studying an experimental treatment combining two drugs, pozelimab and cemdisiran, to evaluate their long-term safety and effectiveness for adults with paroxysmal nocturnal hemoglobinuria PNH. This Phase 3 study aims to answer key questions about how well this combination works, potential side effects, drug levels in the blood, and whether the body develops antibodies against the drugs that could affect treatment. Participants include those who have completed treatment in a related parent study and those with a specific C5 genetic variation making them resistant to other treatments. The study involves administering the study drugs per protocol, including a loading dose of pozelimab given intravenously on Day 1 for some participants. The study is open-label and non-randomized, with two groups based on prior treatment history or genetic markers. During the study, participants will attend clinic visits to receive treatments and undergo various assessments such as blood tests to monitor hemolysis and hemoglobin levels, measure drug concentrations, and check for antibodies. Researchers will track serious and other adverse events, treatment discontinuation, and changes in quality of life. The study lasts up to around 108 weeks, with ongoing safety and effectiveness monitoring throughout this period.

Researchers are evaluating the safety and effectiveness of oral Apabetalone combined with background dapagliflozin treatment for up to 12 weeks in adults with type 2 diabetes mellitus T2DM who have experienced probable or confirmed COVID-19 infection. Participants must have symptoms of Long COVID lasting at least 2 months within 3 months from the start of COVID-19, which cannot be explained by other diagnoses. This phase II, open-label multicentre trial aims to better understand treatment options for this group of patients. Participants will take oral Apabetalone 100 mg capsules twice daily with meals while continuing their daily dapagliflozin 10 mg therapy for diabetes. The study involves seven in-person clinic visits where data will be collected to assess the treatments effects. After screening and consent, eligible participants begin Apabetalone treatment on Day 1 and continue it at home under study supervision. During the trial, participants will undergo various assessments including symptom evaluations and functional status tools related to Long COVID. The primary outcome is the patient acceptable symptom state at 90 days. Secondary measures include fatigue, dyspnea, and post-exertional malaise assessments. Safety and adherence will be monitored throughout, with the total study duration covering treatment and follow-up visits over approximately 12 weeks.

Researchers are evaluating the safety and effectiveness of several long-acting antibody treatments for adults with moderately to severely active ulcerative colitis UC. This Phase 2, multicenter platform study aims to compare multiple investigational therapies, including both single agents and combinations, to better understand their potential benefits and risks. The study is sponsored by Spyre Therapeutics, Inc. and involves adults aged 18 to 75 years with active UC confirmed by endoscopy and histology.

Researchers are evaluating MB12, a proposed pembrolizumab biosimilar, compared to Keytruda in combination with pemetrexed-platinum chemotherapy as the first treatment for patients with advanced metastatic non-squamous non-small cell lung cancer NSCLC. This randomized, double-blind, multicenter study aims to compare the pharmacokinetics, efficacy, safety, and immune response of MB12 and Keytruda in this patient population. Participants will be assigned to one of three groups MB12 with pemetrexed and carboplatin or cisplatin, European Union-sourced Keytruda with the same chemotherapy, or US-sourced Keytruda with the same chemotherapy. MB12 and Keytruda are given intravenously at 200mg every three weeks on Day 1. Pemetrexed is given at 500 mgm2 IV every three weeks on Day 1, while carboplatin or cisplatin is administered every three weeks for four cycles. During the study, participants will be monitored from Week 1 to Week 52 for drug levels in the body, treatment effectiveness, safety, and immune response. Key assessments include measuring pharmacokinetic bioequivalence and efficacy equivalence within the first 24 weeks, along with longer-term safety and immune monitoring. The study is led by mAbxience Research S.L. and is expected to continue until September 2027.

Researchers are evaluating the effectiveness and safety of inavolisib combined with Phesgo compared to a placebo combined with Phesgo as maintenance treatment for participants with previously untreated HER2-positive advanced breast cancer that has a PIK3CA mutation. This Phase 3 study focuses on participants with locally advanced or metastatic breast cancer who have completed induction therapy. Participants first receive induction therapy with Phesgo plus taxane-based chemotherapy. Following this, they enter the maintenance phase where they are randomly assigned to receive either inavolisib tablets taken orally once daily for 21 days of each 21-day cycle along with Phesgo administered subcutaneously every 3 weeks, or a matching placebo tablet with Phesgo on the same schedule. Optional endocrine therapy may be given based on the investigators choice according to standard care. Throughout the study, participants undergo regular monitoring including tumor assessments, quality of life questionnaires, and safety evaluations lasting up to approximately 111 months. Key outcomes measured include progression-free survival assessed by investigators, overall survival, response rates, duration of response, and adverse event rates. Plasma concentrations of inavolisib are also measured at specific timepoints. Participants will be followed closely during and after treatment to assess these outcomes over an extended period.

Autism spectrum disorders ASDs are complex neuro-developmental conditions characterized by ongoing difficulties in social communication and interaction, along with restricted and repetitive behaviors or interests. These disorders involve inflammatory conditions and immune system dysfunction, which has led researchers to explore cell-based therapies as a potential treatment. This study is a Phase 1 clinical trial focusing on evaluating the safety and effects of stem cells for children with ASD. Participants in the trial receive three intravenous doses of allogeneic Wharton Jelly Mesenchymal Stromal Cells WJMSC at a dose of 1 million cells per kilogram of body weight. These doses are administered every two weeks as the treatment approach. The study aims to assess both safety and efficacy over a follow-up period extending to 12 months after treatment. During the study, researchers monitor participants through laboratory tests to evaluate the safety profile of the treatment. They also measure changes in attention and hyperactivity symptoms using the Adult ADHD Self-Report Scale over a 12-month follow-up. The trial involves children aged 4 to 14 years diagnosed with ASD, with regular assessments and follow-up visits scheduled throughout the year to observe treatment effects and ensure participant safety.

Blastic Plasmacytoid Dendritic Cell Neoplasm BPDCN is a very rare blood cancer with no agreed-upon best treatment. Researchers are working internationally to gather detailed information on how BPDCN presents, how it is diagnosed, the treatments patients receive, and their outcomes. The study aims to build a large database to better understand the disease and to develop treatment recommendations based on collected data. This study is an international registry collecting information from multiple centers about patients diagnosed with BPDCN. It includes both retrospective and prospective data from patients worldwide. The data collected covers patient details, disease characteristics, treatment information, outcomes, causes of death, and the conclusion of data collection. Consent will be obtained from prospective patients, and quality control is managed by the Immune Oncology Research Institute. Participants will provide information through questionnaires completed by their treatment centers. Researchers will analyze overall survival, complete remission rates, duration of first remission, and event-free survival over five years. This observational study does not involve treatment but gathers and monitors detailed clinical data to improve understanding and guide future therapies for BPDCN.

Researchers are evaluating the use of allogenic dentin grafts, derived from human-extracted teeth, for preserving the alveolar ridge after tooth extraction. This trial aims to test two types of grafts demineralized dentin allografts DDA and whole tooth allografts WTA, as alternatives to traditional autogenous bone grafts. These grafts may offer a sustainable and scalable solution by repurposing extracted teeth, which are usually discarded, and addressing the limitations of autogenous grafts such as donor site issues and limited availability. Participants will receive one of the two allogenic dentin grafts DDA or WTA applied to preserve the alveolar ridge following tooth extraction, or no graft in the control group. The study is prospective and non-randomized, focusing on clinical and radiographic evaluation. The grafts are prepared from healthy human donors, and the intervention supports innovative, sustainable dental practices. The trial includes a control group to compare outcomes without grafting. During the study, participants will undergo assessments including cone beam computed tomography CBCT scans to measure changes in alveolar ridge width and height from baseline to three months after extraction. Researchers will monitor the biocompatibility and effectiveness of the grafts by comparing these measurements across groups. The total follow-up period for primary outcomes is three months post-extraction, with evaluations of alveolar crest dimensions to support future prosthetic rehabilitation.

Researchers are studying patients referred for sleep studies at Jordan University Hospital and Jordan Hospital, including those using at-home sleep study kits. This study aims to collect demographic and clinical data to evaluate the connection between obstructive sleep apnea OSA, facial discoloration, vasovagal symptoms, and smoking habits. It also investigates how treatment for OSA affects these factors and the timing of symptom appearance related to smoking initiation. Participants will undergo a physical exam to assess facial discoloration, which will be graded by severity and photographed with consent. Sleep studies will be performed either in-lab using polysomnography or at home with a sleep study device. OSA severity will be classified by the apnea-hypopnea index AHI. Those with positive sleep study results will be followed up at 3 weeks and 6 months to monitor treatment, symptom improvement, smoking habits, and vasovagal symptoms. Participants with negative results will also be followed for changes in smoking and vasovagal symptoms. Participants will be interviewed at their initial visit to collect medical history and smoking information, and their faces examined and photographed for discoloration. Follow-up will occur in clinic or by phone and email at 3 weeks and 6 months. Data analysis will assess the relationships between OSA, facial discoloration, vasovagal symptoms, smoking tendency, and treatment effects. Confidentiality and consent are ensured, and participants treatment plans will not be altered during the study.