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Found 2 Actively Recruiting clinical trials
Actively Recruiting
This trial studies participants with relapsed Small Cell Lung Cancer who have received prior treatment. It aims to compare the effectiveness and safety of a new drug called ZL-1310 with therapies chosen by investigators, such as Topotecan, Lurbinectedin, or Amrubicin. This is a Phase 3, randomized, open-label study evaluating outcomes including tumor response rate and overall survival over a period of up to 27 months. Participants receive either ZL-1310 alone or one of the Investigator's Choice therapies as treatment. The study includes screening to confirm measurable disease and eligibility. Treatments are administered according to the study protocol, and tumor biopsies or archived tissue samples are collected at screening. Both treatment groups are monitored for response and side effects throughout the study period. During the trial, participants undergo regular assessments including tumor imaging evaluated by an independent review, and survival status is tracked for up to 27 months. Researchers monitor safety, treatment adherence, and disease progression. Participants are expected to comply with study visits and procedures for the entire duration of the trial to help evaluate the benefits and risks of the treatments.
Actively Recruiting
Researchers are investigating the effectiveness and safety of combining luspatercept with low-dose thalidomide compared to luspatercept alone in adults with transfusion-dependent beta-thalassemia. This inherited blood disorder significantly impacts health and quality of life, and there are currently few specific treatments available. The study is a phase 2, randomized, double-blind, placebo-controlled trial conducted across multiple centers, aiming to reduce the need for regular red blood cell transfusions in these patients. Participants are randomly assigned to two groups: one receives luspatercept (1.0 mg/kg every 21 days) combined with low-dose thalidomide (50 mg daily), and the other receives luspatercept with a placebo daily. Treatment lasts for 48 weeks. Both groups may also receive supportive care such as blood transfusions, iron chelators, and other therapies as needed. The study includes a screening period, a treatment phase, and a follow-up period. During the follow-up visits at weeks 12, 24, 36, and 48, participants undergo physical exams, vital sign checks, blood tests, and assessments of transfusion needs, iron levels, quality of life, and safety monitoring. Researchers measure how many participants achieve a significant reduction in their transfusion burden between weeks 13 and 24 compared to before treatment. Detailed records of side effects and treatment compliance are also collected to evaluate overall safety and effectiveness.