Ignite Creation Date:
2024-05-06 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05063123
Status:
WITHDRAWN
Last Update Posted:
2021-12-22
First Post:
2021-09-13
Brief Title:
Study to Assess an Interphase Cycle With Flotetuzumab
Sponsor:
Stichting Hemato-Oncologie voor Volwassenen Nederland
Organization:
Stichting Hemato-Oncologie voor Volwassenen Nederland
Study Overview
Official Title:
A Phase II Multicenter Study to Assess the Feasibility and Efficacy of the Addition of an Interphase Cycle With Flotetuzumab Prior to Start Conditioning for an Allogeneic HCT in AML With MRD After 2 Cycles of Intensive Chemotherapy
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Withdrawal of MacroGenics pharmaceutical company
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HOVON162AML
Brief Summary:
Patients who have measurable residual disease MRDpos defined as MRD 01 by flowcytometry or detectable mutant Nucleophosmin 1 NPM1 by quantitative polymerase chain reaction qPCR after two cycles of intensive chemotherapy prior to start conditioning for an allogeneic Hematopoietic Cell Transplantation HCT have a very high risk of relapse after transplantation Important questions in the field are whether patients with MRD after intensive chemotherapy can be converted to MRD negativity ie undetectable MRD MRDneg and whether this conversion impacts on the relapse rate after transplantation This trial aims to develop effective interphase treatment for patients in morphological complete remission CR with MRD after at least 2 cycles of intensive chemotherapy and prior to start conditioning for an allogeneic HCT Flotetuzumab a bispecific antibody-based molecule against CD3 and CD123 in a dual-affinity re-targeting antibody DART format is a new treatment modality based on immunomodulation The rationale to use flotetuzumab in this study is 1 its antileukemic activity reported in RR AML 2 its limited extra-medullary ie tissue toxicity and 3 its short halflife
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2021-001041-12 | EUDRACT_NUMBER | None | None |