Viewing Study NCT03697707



Ignite Creation Date: 2024-05-06 @ 12:10 PM
Last Modification Date: 2024-10-26 @ 12:55 PM
Study NCT ID: NCT03697707
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2022-10-10
First Post: 2018-10-04

Brief Title: Efficacy and Safety of Immunotherapy With Allogeneic Dendritic Cells DCP-001 in Patients With Acute Myeloid Leukaemia
Sponsor: Mendus
Organization: Mendus

Study Overview

Official Title: An International Multicentre Open-label Study To Evaluate The Efficacy and Safety of Two Different Vaccination Regimens of Immunotherapy With Allogeneic Dendritic Cells DCP-001 in Patients With Acute Myeloid Leukaemia That Are In Remission With Persistent MRD
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2022-10
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: ADVANCE-II
Brief Summary: Phase II study to evaluate safety and efficacy of DCP-001 in patients with AML in CR and with presence of MRD
Detailed Description: International multicentre open-label proof of concept study exploring two different dose groups of the allogeneic dendritic cell vaccine DCP-001 Cohort 1 consists of 10 patients that will receive 25E6 DCP-001 cells per vaccination and Cohort 2 consists of 10 patients who will receive 50E6 DCP-001 cells per vaccination All patients will be given two additional booster vaccinations of 10E6 cells Each patient will be followed up for 12 months after the 4th vaccination Safety will be monitored throughout the study Sera and cell samples blood and bone marrow will be collected for assessment of efficacy MRD evaluation and immune response monitoring

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None