drugset / Trial / NCT03441048
Lintuzumab-Ac225 in Combination with Cladribine + Cytarabine + Filgastrim + Mitoxantrone (CLAG-M) for Relapsed/Refractory Acute Myeloid Leukemia
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a prospective, single-center phase I clinical study aimed at determining the maximum-tolerated dose, recommended phase 2 dose and safety of Lintuzumab-Ac225 in combination with CLAG-M chemotherapy in the management of relapsed/refractory acute myeloid leukemia. This study uses a 3+3 design with a five-patient cohort at the recommended phase 2 dose.
Timeline
- Start
- 2018-05-22
- Primary completion
- 2024-05-22
- Completion
- 2024-05-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 1.6 ug/kg | — |
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 3.2 ug/kg | — |
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 4.7 ug/kg | — |
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 6.4 ug/kg | — |
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 8 ug/kg | — |
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 0.25 unknown | — |
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 0.5 unknown | — |
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 0.75 unknown | — |
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 1 unknown | — |
| Subject | LINTUZUMAB ACTINIUM AC-225 | Other / unclassified | 1.25 unknown | — |
| Background | Cladribine | Small molecule | 5 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 2 g/kg | Intravenous |
| Background | G-CSF | Protein / enzyme biologic | 300 ug | — |
| Background | Mitoxantrone | Small molecule | 10 mg/m2 | Intravenous |