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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04582864
Other study ID # 202011122
Secondary ID 5P50CA171963
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 20, 2021
Est. completion date June 30, 2029

Study information

Verified date May 2024
Source Washington University School of Medicine
Contact Matthew Christopher, M.D., Ph.D.
Phone 314-273-0286
Email christopherm@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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Study Design


Intervention

Drug:
Flotetuzumab
Will be provided by MacroGenics Inc.
Procedure:
Donor lymphocyte infusion
DLI represents a non-specific form of adoptive cell therapy which involves infusion of a pool of allogeneic immune cells, including CD4+ T cells, CD8+ T cells, regulatory T cells (T Regs), natural killer (NK) cells and professional antigen presenting cells.

Locations

Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (3)

Lead Sponsor Collaborator
Washington University School of Medicine MacroGenics, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy as measured by number of participants with CR(mrd), CR, and CRi 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])
At the end of Cycle 1 (each cycle is 28 days)
Secondary Efficacy as measured by number of participants with CR and CRi 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])
At the end of Cycle 2 (each cycle is 28 days)
Secondary Overall response rate 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%
At the end of Cycle 2 (each cycle is 28 days)
Secondary Morphologic leukemia-free state (MLFS) rate -MLFS: Bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required At the end of Cycle 2 (each cycle is 28 days)
Secondary Partial remission (PR) rate -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% At the end of Cycle 2 (each cycle is 28 days)
Secondary Stable disease (SD) rate -SD: Absence of CR(mrd), CR, CRi, PR, MLFS; and criteria for PD not met At the end of Cycle 2 (each cycle is 28 days)
Secondary Progression-free survival (PFS) rate 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
Through follow-up (approximately 2 years)
Secondary Overall survival (OS) -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. Through follow-up (approximately 2 years)
Secondary Incidence of adverse events as measured by CTCAE v5.0 From start of treatment through 28 days following completion of treatment (estimated to be 84 days)
Secondary Cytokine release syndrome (CRS) grading as measured by ASTCT Consensus Guidelines 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 symptoms; requirement for ventilator support or grade 4 organ toxicity (excluding transaminitis)
Grade 5 Death
At the end of Cycle 2 (each cycle is 28 days)
Secondary Neurotoxicity grading as measured by 2019 ASTCT Consensus Guidelines At the end of Cycle 2 (each cycle is 28 days)
Secondary Incidence of acute Graft versus Host Disease (GvHD) as measured by MAGIC Criteria Through follow-up (approximately 2 years)
Secondary Incidence of chronic Graft versus Host Disease (GvHD) as measured by NIH severity score Through follow-up (approximately 2 years)
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