At a glance
ClinicalIndex Comparison Record- ✓Confirmed prior diagnosis of AML and underwent allogeneic hematopoietic stem cell transplant as consolidation therapy in morphologic complete remission
- ✓ECOG performance status 0-2
- ✓Age ≥18 years
- ✓At least 30 days from transplant with morphologic evidence of disease progression on bone marrow biopsy
- ✕No evidence of donor engraftment (100% patient DNA in bone marrow or peripheral blood after alloHSCT)
- ✕Active AML in central nervous system (CNS) or testes
- ✕Active, uncontrolled infection (controlled infections under treatment may be eligible)
- ✕Active acute or chronic GVHD requiring GVHD therapy within 30 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ib to Investigate the CD123-targeted DART Flotetuzumab Following Allogeneic Transplant for Patients With CD123+ Acute Myeloid Leukemia
In Brief
A Phase 1 clinical trial evaluating Flotetuzumab for Leukemia, Myeloid, Acute. Completed, enrolled 3 participants across 1 site.
Detailed Summary
The purpose of this research study is to determine if the study drug, flotetuzumab, is safe and tolerable when given to participants with acute myeloid leukemia (AML) that has relapsed after transplant.
Study Details
Timeline
Interventions
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.