Study to Assess an Interphase Cycle With Flotetuzumab. (HOVON162AML)
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|ClinicalTrials.gov Identifier: NCT05063123|
Recruitment Status : Withdrawn (Withdrawal of MacroGenics (pharmaceutical company))
First Posted : September 30, 2021
Last Update Posted : December 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|AML||Drug: Flotetuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||January 2022|
|Estimated Primary Completion Date :||August 2024|
|Estimated Study Completion Date :||December 2026|
Single arm - Flotetuzumab
1 - 3 cycles of Flotetuzumab. Flotetuzumab will be administered intravenously via continuous (pump) administration. At least for the first 7 days of cycle 1, the drug will be administered in an inpatient hospital setting, but afterwards may be administered in an outpatient setting using an ambulatory pump configuration. Flotetuzumab will be dosed using multi-step increments in dosing over the first week as follows: 30, 60, 100, 200, 300, and 400 ng/kg/day each for 24 hours. On day 7, the dose will be increased to 500 ng/kg/day and administered as a continuous infusion for the remainder of cycle 1. After 1 cycle of flotetuzumab patients will proceed with alloHCT. However if there is a delay in access to transplantation, patients are allowed to receive up to 2 additional cycles flotetuzumab provided all non-hematologic toxicities have resolved to Grade <2.
Flotetuzumab will be given after at least 2 intensive chemotherapy cycles and before the start of the conditioning regimen prior to allo-HCT.
- Rate of CR/CRi without MRD defined as MRD < 0.1% by flowcytometry or undetectable mutant NPM1 by qPCR after 1 cycle of flotetuzumab [ Time Frame: 1 year after inclusion last patient ]
The primary objective of this study is to assess the rate of MRDneg remission after treatment with one cycle of flotetuzumab.
The rate of MRDneg remission after one treatment cycle will be tabulated and exact 95% confidence intervals will be calculated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05063123
|Principal Investigator:||M. Jongen-Lavrencic, PhD||Erasmus MC|