Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ara-C · 1 trial · 1 indication
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...
Ara-C is a small molecule being studied for the treatment of Acute Myeloid Leukemia (AML). It is currently in Phase 2 clinical development as an investigational therapy. The drug is being evaluated in patients with relapsed or refractory AML, meaning the disease has not responded to or has returned after prior treatment.
Ara-C is being developed by BioLineRx Ltd., a biopharmaceutical company. BioLineRx is publicly traded on the NASDAQ under the ticker symbol BLRX. The company is conducting clinical trials to evaluate the safety and efficacy of Ara-C in patients with Acute Myeloid Leukemia.
Ara-C is currently in Phase 2 clinical development. It has completed a Phase 2a study in patients with relapsed or refractory Acute Myeloid Leukemia. The drug is investigational and has not been approved by regulatory authorities for commercial use.
Ara-C has been evaluated in one completed clinical trial, NCT01838395. This was a Phase 2a study titled "Phase IIa Study Evaluating Safety and Efficacy of BL-8040 in Relapsed/Refractory AML Patients." The trial enrolled 42 participants with Acute Myeloid Leukemia and was conducted in the United States and Israel.
Yes, Ara-C is also known as BL-8040. The clinical trial NCT01838395, which evaluated the drug in relapsed or refractory Acute Myeloid Leukemia patients, refers to the investigational agent as BL-8040. Both names refer to the same drug candidate being developed by BioLineRx.