Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02575963 | Lintuzumab-Ac225 in Older Acute Myeloid Leukemia (AML) Patients | PHASE1/PHASE2 | COMPLETED | 40 | — | — | Oct 1, 2012 | May 1, 2020 | Jul 19, 2023 | - | — |
| Name | Type | Description |
|---|---|---|
| Cytarabine (Phase 1 only) | DRUG | Low dose cytarabine administered at 20 mg subcutaneously every 12 hours for the first 10 days (Days 1 to 10) of every cycle. Cycle 1 can last up to 52 days (depending on the schedule of study drug dosing) in order to allow for recovery from Lintuzumab-Ac225. Cycles 2-12 will last 28 days each. |
| Lintuzumab-Ac225 | BIOLOGICAL | In Phase 1 the starting dose level was 1.0 μCi/Kg of Lintuzumab-Ac225 and 15 μg/Kg unlabeled HuM195 divided into 2 equal fractionated doses (0.5 μCi/Kg and 7.5 μg /Kg + 0.5 μCi/Kg and 7.5 μg /Kg) with the first fraction administered approximately 4-7 days after 1 cycle of low dose cytarabine and the second fraction administered 4-7 days after the first fraction, followed by up to 11 more cycles. In Phase 2 the dose will be 4.0 μCi/Kg Lintuzumab-Ac225 and 25 μg/Kg unlabeled HuM195 divided into 2 equal fractions with the first fraction given on Day 1 and the second fraction given on Day 5-8. |
| Furosemide (Phase 1 only) | DRUG | 40 mg by mouth daily one day prior to treatment with Lintuzumab-Ac225 and continuing for 10 days following administration of the 2nd divided dose. |
| Spironolactone | DRUG | 25 mg by mouth daily, administered 10 days after second dose of 225Ac-HuM195 and continued for 12 months. |