drugset / Trial / NCT03705858
Actinium-225-Lintuzumab in Patients With Acute Myeloid Leukemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |