Actively Recruiting
A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
Led by Bio-Path Holdings, Inc. · Updated on 2025-03-10
48
Participants Needed
4
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older with histologic evidence of refractory or relapsed AML who have failed available therapies
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2
- For dose expansion, documented AML diagnosis and eligibility for decitabine therapy
- Adequate liver function: AST and ALT no more than 2.5 times upper limit of normal; total bilirubin usually 1.5 times or less upper limit of normal (waivers possible)
- Adequate kidney function with estimated creatinine clearance at least 60 mL/min
- Female participants of childbearing potential must agree to use acceptable birth control during the study and for 6 months after last dose
- Male participants must agree to use acceptable contraception during the study
- Recovered from effects of prior surgery, radiotherapy, or anti-cancer treatment (except alopecia)
- Willing and able to provide written informed consent
You will not qualify if you...
- Active non-hematologic or lymphoid cancers other than AML treated with immunotherapy, targeted therapy, or chemotherapy within the past 12 months
- Known active leptomeningeal leukemia requiring intrathecal therapy (with exceptions based on spinal fluid testing)
- Isolated treatable extramedullary leukemia without bone marrow criteria for AML
- Acute promyelocytic leukemia with t(15;17)(q22;q12) PML-RARA
- Chronic myeloid leukemia in any phase
- Received any anti-cancer therapy within 14 days before starting study treatment except hydroxyurea or leukapheresis
- Receiving other investigational agents
- Pregnant or breastfeeding females
- Substance abuse or conditions interfering with study participation or evaluation
- HIV infection with CD4+ T-cell counts below 350 cells/mcL or active hepatitis B or C infection
- History of hypersensitivity to hypomethylating agents unless considered irrelevant
- Unresolved toxicity greater than CTCAE Grade 1 from prior therapy or procedure excluding alopecia
- Conditions that may interfere with treatment tolerance or study conduct (e.g., unstable angina, severe heart failure, uncontrolled hypertension, significant cardiac rhythm abnormalities)
- Recent serious cardiovascular events within 6 months (myocardial infarction, unstable angina, bypass surgery, stroke, or transient ischemic attack)
- Uncontrolled seizures within past 2 months
- Unable or unwilling to communicate or cooperate with study procedures
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
Scripps Green Hospital
La Jolla, California, United States, 92037
Actively Recruiting
2
UCLA Medical Center
Los Angeles, California, United States, 90024
Actively Recruiting
3
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, United States, 10021
Actively Recruiting
4
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
M
Michael Hickey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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