Post-transplant Flotetuzumab for AML

PHASE1CompletedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

October 20, 2022

Primary Completion Date

June 18, 2024

Study Completion Date

June 18, 2024

Conditions
Leukemia, Myeloid, Acute
Interventions
DRUG

Flotetuzumab

Patients enrolled on dose level 1 (DL1) will receive flotetuzumab by continuous infusion using multi-step lead-in dosing, and then 500 ng/kg/day on days 7-28. After one cycle, all patients will undergo a bone marrow biopsy to assess response including assessment of minimal residual disease (MRD). Patients who fail to achieve a CR, CRi, CRh (complete remission with partial hematologic recovery), or MLFS may continue with subsequent induction cycles as a continuous infusion up to a total of five cycles. If there is evidence of response (CR, CRi, CRh, or MLFS) and the toxicities of treatment are acceptable, patients will be eligible for two consolidation cycles. Additional bone marrow biopsies for response assessment will be performed after the second cycle. If there is a need to de-escalate dosing based on toxicity, then patients will be enrolled on DL-1 using multi-step lead-in dosing, and then 300 ng/kg/day on days 5-28 of the first cycle and days 1-28 of subsequent cycles.

Trial Locations (1)

21231

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

MacroGenics

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER