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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01838395 | Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients | PHASE2 | COMPLETED | 42 | — | — | Apr 1, 2013 | Jul 20, 2023 | Sep 19, 2024 | 10 | United States, Israel |
Number of participants with Adverse event affecting the safety and tolerability of BL-8040 + Ara-C by dose level (overall, dose limiting events, related Adverse Events (AEs), Serious Adverse Events (SAEs), related SAEs, AE by severity and death) Toxicity grade was assessed according to version V4.03 of NCI-CTCAE
| Arm | Type | Description |
|---|---|---|
| BL-8040 0.5mg/kg + Ara-C 1.5 or 3 g/m2/d per dose (based on age) | EXPERIMENTAL | Arm 1: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 0.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. |
| BL-8040 0.75mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | EXPERIMENTAL | Arm 2: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 0.75 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. |
| BL-8040 1.0mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | EXPERIMENTAL | Arm 3: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 1 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. |
| BL-8040 1.25mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | EXPERIMENTAL | Arm 4: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 1.25 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. |
| BL-8040 1.5mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | EXPERIMENTAL | Arm 5: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 1.5 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. |
| BL-8040 2mg/kg + Ara-C 1.5 or 3 g/m2/d (based on age) | EXPERIMENTAL | Arm 6: Participants will be dosed with SC injections of BL-8040 over two days followed by concurrent administration of 2 mg/kg BL-8040 with cytarabine (Ara-C) 1.5 or 3 g/m2/d per dose (based on age) during 5 days. |
| Name | Type | Description |
|---|---|---|
| Ara-C | DRUG | IV (intravenous administration) |
| BL-8040 | DRUG | SC (subcutaneous injection) |
Inclusion Criteria: 1. Adult men and women subjects aged 18 to 75, inclusive. 2. Confirmed diagnosis of relapsed/refractory AML (WHO criteria) Refractory subjects, up to second consecutive salvage . Relapsed subjects including first and second relapse. 3. AML relapse \> 6 months since autologous or...