Ignite Creation Date:
2024-05-06 @ 3:34 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04676243
Status:
WITHDRAWN
Last Update Posted:
2022-05-25
First Post:
2020-12-09
Brief Title:
Daunorubicin or Idarubicin With Cytarabine Plus Quizartinib vs Physicians Choice in Newly Diagnosed FLT3-ITD AML
Sponsor:
University Hospital Heidelberg
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
Randomized Study in Newly Diagnosed AML With FLT3-ITD Comparing Daunorubicin Cytarabine or IdarubicinCytarabine and Quizartinib to Physicians Choice
Status:
WITHDRAWN
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study turned out no longer feasible
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Q-SOC
Brief Summary:
The orally administered second-generation bis-aryl urea tyrosine kinase inhibitor quizartinib is very specific for FLT3 has a high capacity for sustained FLT3-inhibition and an acceptable toxicity profile Furthermore single agent quizartinib doubled the response rate as compared to standard of care in a randomized study in rr-AML Combination therapy of quizartinib with intensive standard induction chemotherapy has been shown to be safe and moreover single agent quizartinib maintenance therapy is feasible even after allogeneic HCT
The efficacy of quizartinib in combination with intensive induction and post-remission therapy including allogeneic HCT and single agent quizartinib as maintenance therapy is evaluated by this protocol This approach is compared in a randomized manner to the current standard of care
The efficacy of quizartinib in combination with intensive induction and post-remission therapy including allogeneic HCT and single agent quizartinib as maintenance therapy is evaluated by this protocol This approach is compared in a randomized manner to the current standard of care
Detailed Description:
This is a multicenter upfront randomized phase III trial of patients with FLT3-ITD positive AML comparing quizartinib in combination with SOC chemotherapy versus treatment according to physicians choice PhC Efficacy is assessed by comparing EFS between the quizartinib and the PhC arm of the study
Primary objective To improve modified event-free survival mEFS with Quizartinib added to induction and consolidation therapy followed by single agent maintenance therapy compared to physicians choice PhC
Secondary objectives To improve overall survival OS with Quizartinib added to conventional therapy compared to physicians choice To improve remission including CRCRiCRh rate with Quizartinib added to conventional therapy compared to physicians choice To reduce measurable residual disease MRD with Quizartinib added to conventional therapy compared to physicians choice after induction MRDind consolidation MRDcons before allogeneic hematopoietic cell transplantation MRDpre-HCT and maintenance MRDmaintenance therapy Assessment of patient reported outcomes PRO after induction consolidation and maintenance therapy and after two years Evaluation of safety based on duration of neutropenia and leukopenia incidence of infection duration of initial hospitalization and number of transfusions eg packed red blood cells and platelets Cost-effectiveness analysis of the two different treatment schedules from health care payers perspective
Budget impact analysis of introducing effective treatment schedules in everyday clinical practice
Primary objective To improve modified event-free survival mEFS with Quizartinib added to induction and consolidation therapy followed by single agent maintenance therapy compared to physicians choice PhC
Secondary objectives To improve overall survival OS with Quizartinib added to conventional therapy compared to physicians choice To improve remission including CRCRiCRh rate with Quizartinib added to conventional therapy compared to physicians choice To reduce measurable residual disease MRD with Quizartinib added to conventional therapy compared to physicians choice after induction MRDind consolidation MRDcons before allogeneic hematopoietic cell transplantation MRDpre-HCT and maintenance MRDmaintenance therapy Assessment of patient reported outcomes PRO after induction consolidation and maintenance therapy and after two years Evaluation of safety based on duration of neutropenia and leukopenia incidence of infection duration of initial hospitalization and number of transfusions eg packed red blood cells and platelets Cost-effectiveness analysis of the two different treatment schedules from health care payers perspective
Budget impact analysis of introducing effective treatment schedules in everyday clinical practice
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