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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05506956 | Post-transplant Flotetuzumab for AML | PHASE1 | COMPLETED | 3 | — | — | Oct 20, 2022 | Jun 18, 2024 | Sep 12, 2025 | 1 | United States |
Number of participants with dose-limiting toxicities (DLTs) at specified dose levels to determine MTD
| Arm | Type | Description |
|---|---|---|
| Flotetuzumab Following Allogeneic Transplant | EXPERIMENTAL | All participants will receive one cycle (28 days) of flotetuzumab. After one cycle, all participants will undergo a bone marrow biopsy to assess response and based on the response, may receive additional cycles up to a total cycle of six cycles. |
| Name | Type | Description |
|---|---|---|
| Flotetuzumab | DRUG | 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. |
Inclusion Criteria: 1. A confirmed prior diagnosis of AML and underwent an alloHSCT as a form of consolidation in a morphologic complete remission 2. ECOG performance status 0-2 3. Ability to give informed consent 4. In agreement to use an effective barrier method of birth control to avoid pregnanc...