drugset / Trial / NCT03705858

Actinium-225-Lintuzumab in Patients With Acute Myeloid Leukemia

NCT03705858 ↗

Phase 1 Withdrawn Joseph Jurcic
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to see what dose of 225Ac-lintuzumab is safest to give to acute myeloid leukemia (AML) patients who are in remission but still have minimal residual disease (MRD). About 12 subjects will be asked to take part in this phase 1, 3+3 dose-escalation study. In addition to confirming the safety profile of postremission therapy with 225Ac-lintuzumab, preliminary evidence of efficacy will be assessed by estimating progression-free survival (PFS) and overall survival (OS), and serially evaluating for MRD using cytogenetics, fluorescence in situ hybridization (FISH), or flow cytometric assays, as applicable.

Timeline

Start
2019-02-28
Primary completion
2019-02-28
Completion
2019-02-28

Outcome

Outcome not reported

Stopped: “Due to difficulty in finalizing the contract”

Drugs

EvaluationDrugModalityDoseRoute
Subject Ac-Lintuzumab Monoclonal antibody 0.00925 mbq/kg Intravenous
Subject Ac-Lintuzumab Monoclonal antibody 0.0185 mbq/kg Intravenous
Subject Ac-Lintuzumab Monoclonal antibody 0.02775 mbq/kg Intravenous
Subject Ac-Lintuzumab Monoclonal antibody 0.037 mbq/kg Intravenous