Population Pharmacokinetic-pharmacodynamic Study of Rituximab in Children

Status Not yet recruiting

Clinical Trial Summary

To establish a population pharmacokinetic and pharmacodynamic model of rituximab in children with hemopathy. To optimize the administration of rituximab in the treatment of children based on pharmacokinetic model.

Clinical Trial Description

hemotherapy for children with lymphoma: rituximab (375mg/m2 BSA) was added intravenously from COPADM1 regimen. once every 3 weeks to 4 weeks, combined with corresponding chemotherapy, a total of 4 times. Rituximab (375mg/m2 BSA) was administered intravenously for lymphoproliferative diseases and Epstein-Barr(EB) virus-associated B lymphoproliferative diseases after hematopoietic stem cell transplantation. Once a week, a total of 4 times. Primary immunologic thrombocytopenic purpura(ITP) and autoimmune hemolytic anemia(AIAH) patients received rituximab (100mg/m2 BSA) intravenously once a week, a total of 4 times. The children were divided into group A and group B according to the disease type, and each group was randomly divided into two groups (group 1 and group 2) and assigned blood collection points. Burkitt's lymphoma diffuse large B-cell lymphoma follicular lymphoma and other mature B-lymphomas were in group A. Hematopoietic stem cell transplantation, EPstein-Barr virus associated lymphocyte proliferative disease, lymphocyte proliferative change, primary immunologic thrombocytopenic purpura(ITP) and autoimmune hemolytic anemia(AIAH) were in group B. Group 1: Children in the first group were collected 0, 12, 24, and 72 h after the first dose, 0h before and after the second dose, 0h before and after the third dose, 0h before and after the last dose, 48, and 96 h after the last dose. Venous blood was collected at 12 time points. Group 2: Children in the second group were collected 0, 12, 48, and 96 h after the first dose, 0h before and after the second dose, 0h before and after the third dose, 0h before and after the last dose, 24, and 72 h after the last dose. Venous blood was collected at 12 time points. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05324917
Study type	Observational
Source	The Affiliated Hospital of Qingdao University
Contact
Status	Not yet recruiting
Phase
Start date	April 10, 2022
Completion date	April 1, 2023

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03563196` - Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
Completed	`NCT02553486` - Internationally Adopted Children Quality of Life	N/A
Completed	`NCT02903134` - Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity
Completed	`NCT02918890` - Intensive Unimanual (CIMT) and Bimanual Training (HABIT) in Children With Hemiplegia	N/A
Active, not recruiting	`NCT01874847` - PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin	Phase 2/Phase 3
Enrolling by invitation	`NCT01971827` - Effectiveness of a Physical Activity Intervention to Prevent Obesity and Improve Academic Performance	N/A
Enrolling by invitation	`NCT01971840` - Effectiveness of a Physical Activity Intervention on Preventing Obesity During the Adiposity Rebound Period.	N/A
Completed	`NCT01738308` - The Effects of Healing Touch on Post Operative Pediatric Patients	N/A
Completed	`NCT01864811` - Effect of Baby-CIMT in Infants Younger Than 12 Months	N/A
Completed	`NCT01693926` - Effect of Physical Activity an Stress in Children	N/A
Completed	`NCT01943760` - Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty	Phase 4
Completed	`NCT01323010` - Efficacy and Safety of Increasing Doses of Inhaled Albuterol in Children With Acute Wheezing Episodes	N/A
Completed	`NCT01277224` - Effectiveness of a Physical Activity Intervention on the Obesity of Schoolchildren	N/A
Active, not recruiting	`NCT00989547` - Cord Blood Infusion for Type 1 Diabetes Mellitus (T1DM)	Phase 1
Completed	`NCT04051723` - Pre-emptive Scalp Infiltration With Dexamethasone Plus Ropivacaine for Post-Craniotomy Pain in Children	Phase 4
Completed	`NCT03236363` - Effectiveness of MOVI Interventions on Adiposity, Cognition and Motor Competence: MOVI-da10!	N/A
Completed	`NCT03236337` - Effectiveness of MOVI Interventions on Adiposity, Cognition and Subclinical Atherosclerosis: MOVI-daFit!	N/A
Not yet recruiting	`NCT03427697` - Effect of VR and Accommdation Relax on Controlling Myopia in Children	N/A
Completed	`NCT05603507` - Inspiratory Muscle Training in Children With Chest Burn	N/A
Not yet recruiting	`NCT06267339` - Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Population Pharmacokinetic-pharmacodynamic Study of Rituximab in Children With Blood Diseases

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms