Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT04093505
Status:
TERMINATED
Last Update Posted:
2022-07-01
First Post:
2018-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gemtuzumab Ozogamicin in Induction and Glasdegib in Postremission Therapy in Patients With AML (Acute Myeloid Leukemia)
Sponsor:
University Hospital Heidelberg
Organization:
Study Overview
Official Title:
Randomized Phase-III Study to Compare Two Schedules of Gemtuzumab Ozogamicin as Adjunct to Intensive Induction Therapy and to Compare Intensive Postremission Therapy Double Blinded With or Without Glasdegib in Older Patients With Newly Diagnosed AML
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study turned out no longer feasible. End of Recruitment: 25.5.2022
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GnG
Brief Summary:
The study is a randomized phase III trial with a 2x2 factorial design with measurable residual disease and event-free survival as primary endpoints, respectively. Patients are upfront randomized for the two induction schedules (Gemtuzumab Ozogamicin (GO)-147 versus GO-1; ratio 1:1) and for Glasdegib or Placebo (double blinded, ratio 1:1) as adjunct to consolidation therapy and as single agent 6 months maintenance therapy. Chemotherapy backbone for induction therapy is standard 7+3 with cytarabine 200mg/m² continuously day 1 to day 7, daunorubicin 60mg/m² days 1, 2 and 3 and for consolidation therapy intermediate dose cytarabine (1g/m², bi-daily, days 1,2,3). The trial is designed to gain evidence of anti-leukemic activity of GO and Glasdegib in older patients with newly diagnosed acute myeloid leukemia.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: