BP1002 for Relapsed/Refractory Acute Myeloid Leukemia (AML)
This study is testing a new treatment called BP1002, which is a targeted therapy delivered in a special way (liposomal), for adults with acute myeloid leukemia (AML) that has come back (relapsed) or hasn't responded to other treatments (refractory). The study will first look at the safety of different doses of BP1002 alone. Then, it will combine BP1002 with another drug called decitabine to see how safe and effective that combination is. The main goal is to find the safest dose and understand any side effects. You may be able to join if you are 18 or older, have relapsed/refractory AML, and meet other health criteria. The study plans to enroll 48 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It will involve a dose escalation phase for BP1002 alone, followed by a dose expansion phase combining BP1002 with decitabine.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary safety endpoints, such as dose-limiting toxicity and adverse events, will be measured at 30 days.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
At a glance
Conditions
Where it's being run
4 sites across 3 statesStudy leadership
- Gail J Roboz, MD · PRINCIPAL_INVESTIGATOR · Weill Cornell Medical College - New York-Presbyterian Hospital
Who to contact
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What this trial measures
- Identify Dose Limiting Toxicity (DLT) of BP100230 days
Identify DLT of BP1002 using non-hematologic and hematologic measures per NCI CTCAE criteria
- Identify and grade treatment-emergent adverse events (TEAE) of escalating doses of BP100230 days
Identify TEAE of BP1002 using non-hematologic and hematologic measures per NCI CTCAE criteria
- Identify and grade treatment-emergent laboratory abnormalities of escalating doses of BP100230 days
Identify and grade treatment-emergent laboratory abnormalities of escalating doses of BP1002 using non-hematologic and hematologic measure per NCI CTCAE criteria
- Recommended Phase 2 (RP2D) of BP1002210 days
Determine RP2D by evaluating Maximally Tolerated Dose (MTD) data
- Determine plasma pharmacokinetics (PK) of BP1002 using maximum plasma drug concentration30 days
Evaluate plasma PK of BP1002 using maximum plasma drug concentration (Cmax)
- Determine plasma pharmacokinetics (PK) of BP1002 using volume of distribution30 days
Evaluate in vivo PK of BP1002 using volume of distribution (Vd)
- Determine plasma pharmacokinetics (PK) of BP1002 using elimination rate constant30 days
Evaluate in vivo PK of BP1002 using elimination rate constant
- Determine half-life plasma pharmacokinetics (PK) of BP100230 days
Evaluate in vivo PK of BP1002 half-life (t1/2)
- Identify conduction and rhythm changes (treatment emergent QTc elevations or other treatment emergent changes in ECG intervals) of escalating doses of BP100230 days
Collection of 12-lead ECGs at defined intervals to identify conduction and rhythm changes (treatment emergent QTc elevations or other treatment emergent changes in ECG intervals)
- Determine pharmacodynamics (PD) of BP100230 days
Flow cytometry will be performed using peripheral blood to evaluate Bcl-2 target inhibition by BP1002 on pre and post treatment samples
- Determine anti-drug antibody (ADA) levels of BP100230 days
Evaluate ADA via peripheral blood