Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Decitabine

Oblimersen

Antimetabolites

Enzyme Inhibitors

BP1002 single dose in combination with decitabine

BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide

Dose expansion of BP1002 in combination with decitabine

Decitabine (in combination with BP1002)

Michael Hickey

Kiley Borchard

David Hermel, MD

Gary Schiller, MD

Dunay Bach

Gail Roboz, MD

Gail J Roboz, MD

Miranda Lim, BSN, RN

Maro Ohanian, D.O.

This study evaluates the safety and tolerability of escalating doses of BP1002 (Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in patients with refractory/relapsed AML. The study is designed to assess the safety profile, identify DLTs, biologically effective doses, PK, PD and potential anti-leukemic effects of BP1002 as single agent (dose escalation phase) followed by assessing BP1002 in combination with decitabine (dose expansion phase).

A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)

A Phase I/Ib Study of BP1002 (a Liposomal Bcl-2 Antisense Oligodeoxynucleotide) in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)

Flow cytometry assays to determine the effects of BP1002 on Bcl-2 protein expression

Identify DLT of BP1002 using non-hematologic and hematologic measures per NCI CTCAE criteria

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 BP1002 using non-hematologic and hematologic measure per NCI CTCAE criteria

Determine RP2D by evaluating Maximally Tolerated Dose (MTD) data

Evaluate plasma PK of BP1002 using maximum plasma drug concentration (Cmax)

Evaluate in vivo PK of BP1002 using volume of distribution (Vd)

Evaluate in vivo PK of BP1002 using elimination rate constant

Evaluate in vivo PK of BP1002 half-life (t1/2)

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)

Flow cytometry will be performed using peripheral blood to evaluate Bcl-2 target inhibition by BP1002 on pre and post treatment samples

Assess complete remission (CR), CR with incomplete hematologic recovery (CRi), and CR with partial hematologic recovery (CRh) per Döhner 2017

To assess percentage of participants with MLFS and partial remissions per Döhner 2017

To assess blast count reductions per Williams 2016

To assess progression-free survival (PFS), overall survival (OS), and duration of response from date of study entry to study closure or death

Spots Global Cancer Trial Database for decitabine (in combination with bp1002)