Ignite Creation Date:
2024-05-06 @ 3:18 AM
Last Modification Date:
2024-10-26 @ 11:31 AM
Study NCT ID:
NCT02258815
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2013-08-07
Brief Title:
CH1418 1021 Antibody and IL2 After Haplo SCT in Children With Relapsed Neuroblastoma
Sponsor:
University Childrens Hospital Tuebingen
Organization:
University Childrens Hospital Tuebingen
Study Overview
Official Title:
Phase II Feasability Study Using ch1418CHO Antibody and Subcutaneous Interleukin 2 After Haploidentical Stem Cell Transplantation in Children With Relapsed Neuroblastoma
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A six courses regimen consisting of a 8 hour infusion ch1418CHOmAb 20 mgm² for five consecutive days will be administered every 4 weeks starting 60-180 days after previous haploidentical stem cell transplantation
Interleukin 2 will be added to cycles 4-6 at days 6810 1 x 106 IUm²d sc Participants will be premedicated with an intravenous antihistamine and ranitidine within approximately 30 minutes prior and during the infusion of the study agent Pain as an anticipated side effect is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status will be evaluated after 3 and 6 courses and after 1 year
Interleukin 2 will be added to cycles 4-6 at days 6810 1 x 106 IUm²d sc Participants will be premedicated with an intravenous antihistamine and ranitidine within approximately 30 minutes prior and during the infusion of the study agent Pain as an anticipated side effect is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status will be evaluated after 3 and 6 courses and after 1 year
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None