Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05324917
Other study ID # YQ-KY-202101
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 10, 2022
Est. completion date April 1, 2023

Study information

Verified date April 2022
Source The Affiliated Hospital of Qingdao University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date April 1, 2023
Est. primary completion date February 1, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Months to 18 Years
Eligibility Inclusion Criteria: - Children aged 6 months to 18 years (including 6 months and 18 years), male or female. - Burkitt's lymphoma, diffuse large B-cell lymphoma, follicular lymphoma and other mature B-cell lymphoma confirmed by histology or cytology, hematopoietic stem cell transplantation, EB virus associated B-cell proliferative diseases, b-cell proliferative changes, immune thrombocytopenia, Autoimmune hemolytic anemia and other patients with rituximab indications should be treated with rituximab monotherapy or combination. - Eastern Cooperative Oncology Group(ECOG) physical status score was 0-2. - Life expectancy was at least six months. - Women and men with reproductive potential must agree to use effective contraceptive methods during and after treatment. - The subjects or their parents or guardians fully know and sign the informed consent, and the subjects can cooperate to complete the follow-up. Exclusion Criteria: - Patients with known hypersensitivity to rituximab and rat protein. - Previously known active infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV), except for the following patients: Hepatitis B infection [hepatitis B surface antigen (HbsAg) or hepatitis B core antibody (HbcAb) positive] but negative results of HBV DNA polymerase chain reaction (PCR) can be included in the group. - A confirmed history of progressive multifocal leukoencephalopathy (PML). - Exclusion criteria associated with rituximab: tumor cell CD20 negative. - Received live vaccine within 4 weeks prior to enrollment. - Received immunoglobulin therapy within 3 months prior to enrollment. - Participants in the clinical trials of other drugs and taking the test drugs within 3 months. - Any other medical condition, metabolic abnormality, physical abnormality, or laboratory abnormality of clinical significance that, in the investigator's judgment, has reason to suspect that the patient has a medical condition or condition unsuitable for rituximab or that would affect the interpretation of study results or place the patient at high risk.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rituximab
Chemotherapy 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 (once a week)
Rituximab (375mg/m2 BSA) was administered intravenously for lymphoproliferative diseases and EB virus-associated B lymphoproliferative diseases after hematopoietic stem cell transplantation. Once a week, a total of 4 times. ITP and AIHA patients received rituximab (100mg/m2 BSA) intravenously once a week, a total of 4 times.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
The Affiliated Hospital of Qingdao University

Outcome

Type Measure Description Time frame Safety issue
Primary concentration of rituximab in plasma the data of plasma drug concentration and time. 400 days
Secondary Incidence of adverse events Adverse events were recorded to evaluate the safety of the studied drugs. 400 days
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