18 and older, any sex, with Relapsed Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Efficacy as Measured by Number of Participants With CR(Mrd), CR, and CRiPrimary· At the end of Cycle 1 (each cycle is 28 days)
* Complete remission without minimal residual disease (CRmrd): CR with negativity for a genetic marker by RT-qPCR, or CR with negativity by MFC
* Complete remission (CR): Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 10\^9/L (1000/µL); platelet count ≥100 × 10\^9/L (100,000/µL), transfusion independence
* CR with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia (\<1.0 × 10\^9/L \[1000/µL\]) or thrombocytopenia (\<100 × 10\^9/L \[100,000/µL\])
Group
Value
95% CI
Flotetuzumab
0
Efficacy as Measured by Number of Participants With CR and CRiSecondary· At the end of Cycle 2 (each cycle is 28 days)
* Complete remission (CR): Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 10\^9/L (1000/µL); platelet count ≥100 × 10\^9/L (100,000/µL), transfusion independence
* CR with incomplete hematologic recovery (CRi): All CR criteria except for residual neutropenia (\<1.0 × 10\^9/L \[1000/µL\]) or thrombocytopenia (\<100 × 10\^9/L \[100,000/µL\])
Group
Value
95% CI
Flotetuzumab
0
Overall Response RateSecondary· At the end of Cycle 2 (each cycle is 28 days)
* Defined as partial remission or better
* PR: All hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%
Group
Value
95% CI
Flotetuzumab
0
Morphologic Leukemia-free State (MLFS) RateSecondary· At the end of Cycle 2 (each cycle is 28 days)
\- MLFS: Bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required
Group
Value
95% CI
Flotetuzumab
0
Partial Remission (PR) RateSecondary· At the end of Cycle 2 (each cycle is 28 days)
\- PR: All hematologic criteria of CR; decrease of bone marrow blast percentage to 5 to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%
Group
Value
95% CI
Flotetuzumab
2
Stable Disease (SD) RateSecondary· At the end of Cycle 2 (each cycle is 28 days)
\- SD: Absence of CR(mrd), CR, CRi, PR, MLFS; and criteria for PD not met
Group
Value
95% CI
Flotetuzumab
3
Progression-free Survival (PFS) RateSecondary· Through completion of follow-up, up to 2 years (median length of 80 days, full range of 11-149 days)
* PFS will be calculated as the time from the start of the first dose of study drug until the occurrence of disease progression or death from any cause, respectively
* Progressive disease: Evidence for an increase in bone marrow blast percentage (\>50% over baseline), and/or increase of absolute blast counts in the blood (\>50% to \>25 × 10\^9/L) without differentiation syndrome, or new extramedullary disease
Group
Value
95% CI
Flotetuzumab
1.14
0.79 – 2.49
Overall Survival (OS)Secondary· Through completion of follow-up, up to 2 years (median length of 80 days, full range of 11-149 days)
-OS will be calculated as the time from the start of the first dose of study drug until the occurrence of death from any cause.
Group
Value
95% CI
Flotetuzumab
2.66
1.11 – 4.30
Number of Participants With Adverse Events as Measured by CTCAE v5.0Secondary· From start of treatment through 28 days following completion of treatment (median length of 59 days, full range 11-99 days).
Grade 3-5 anemia
Group
Value
95% CI
Flotetuzumab
4
Grade 3-5 febrile neutropenia
Group
Value
95% CI
Flotetuzumab
3
Grade 1-2 sinus tachycardia
Group
Value
95% CI
Flotetuzumab
1
Grade 1-2 adrenal insufficiency
Group
Value
95% CI
Flotetuzumab
1
Grade 1-2 anisocoria
Group
Value
95% CI
Flotetuzumab
1
Grade 1-2 conjunctivitis
Group
Value
95% CI
Flotetuzumab
1
Grade 1-2 scleral hemorrhage
Group
Value
95% CI
Flotetuzumab
1
Grade 1-2 blurred vision
Group
Value
95% CI
Flotetuzumab
1
Number of Participants With Cytokine Release Syndrome (CRS) Grading as Measured by ASTCT Consensus GuidelinesSecondary· Through the end of Cycle 2 (each cycle is 28 days)
* Grade 1:Symptoms are not life threatening and require symptomatic treatment only, e.g., fever, nausea, fatigue, headache, myalgias, malaise
* Grade 2: Symptoms require and respond to moderate intervention; oxygen requirement \< 40% or hypotension responsive to fluids or low-dose of one vasopressor or grade 2 organ toxicity
* Grade 3: Symptoms require and respond to aggressive intervention; oxygen requirement ≥ 40% or hypotension requiring high-dose vasopressors or multiple vasopressors or grade 3 organ toxicity (except transaminitis) or grade 4 transaminitis
* Grade 4: Life-threatening sympt
Grade 1
Group
Value
95% CI
Flotetuzumab
1
Grade 2
Group
Value
95% CI
Flotetuzumab
7
Grade 3
Group
Value
95% CI
Flotetuzumab
3
Grade 4
Group
Value
95% CI
Flotetuzumab
0
Grade 5
Group
Value
95% CI
Flotetuzumab
0
Number of Participants With Neurotoxicity as Measured by 2019 ASTCT Consensus GuidelinesSecondary· Through the end of Cycle 2 (each cycle is 28 days)
Group
Value
95% CI
Flotetuzumab
4
Number of Participants With Acute Graft Versus Host Disease (GvHD) as Measured by MAGIC CriteriaSecondary· Through completion of follow-up, up to 2 years (median length of 80 days, full range of 11-149 days)
Group
Value
95% CI
Flotetuzumab
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events and serious adverse events were collected from start of treatment through 28 days following discontinuation of flotetuzumab (median length of 59 days, full range 11-99 days). All-cause mortality was collected from start of treatment through completion of protocol defined follow-up (median length of 80 days, full range of 11-149 days)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Flotetuzumab
Serious: 8/11 (73%)
Deaths: 10/11
Serious adverse events (9 terms)
Reaction
System
Flotetuzumab
Disease progression
General disorders
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
Febrile neutropenia
Blood and lymphatic system disorders
—
Cytokine release syndrome
Immune system disorders
—
GvHD of the gut
Immune system disorders
—
Sepsis
Infections and infestations
—
Sinusitis
Infections and infestations
—
Dehydration
Metabolism and nutrition disorders
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Other adverse events (131 terms — click to expand)
The investigators hypothesize that flotetuzumab for relapsed AML following allo-HCT will be safe, tolerable and may facilitate preferential immune effector cell retargeting of leukemic cells resulting in improved patient outcomes. Furthermore, administration of a donor lymphocyte infusion (DLI) (if available) in combination with flotetuzumab will be safe, tolerable and may provide additional therapeutic efficacy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Washington University School of Medicine
Last refreshed: 6 December 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04582864.