Romiplostim for Thrombocytopenia in Leukemia Patients
Romiplostim N01
Treatment Study
Summary
Study start date: March 31, 2025
Actual date on which the first participant was enrolled.This clinical trial investigates the use of Romiplostim for treating cancer treatment-induced thrombocytopenia (CTIT) in adults with leukemia. CTIT is a condition where platelet levels drop due to cancer treatments, increasing the risk of bleeding and potentially limiting treatment options. Current management includes platelet transfusions and thrombopoietic agents, but there is limited research on Romiplostim's effectiveness in leukemia patients. By studying this medication, researchers hope to find new ways to manage CTIT, improve treatment outcomes, and enhance the quality of life for patients undergoing cancer therapy. In this phase 2 interventional study, participants receive Romiplostim to assess its effectiveness and safety in increasing platelet counts and reducing bleeding risks. Participants are closely monitored to evaluate how well the drug works in preventing the need for platelet transfusions and managing CTIT. The study focuses on understanding the benefits and any potential side effects of Romiplostim, aiming to establish it as a viable treatment option for leukemia patients experiencing low platelet counts due to cancer treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.97 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, ChinaOpen The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) in Google Maps