What is BP1002 studying for refractory or relapsed acute myeloid leukemia?

BP1002 is being studied to evaluate its safety, dosing, and potential anti-leukemic effects in patients with refractory or relapsed acute myeloid leukemia. The research aims to find the best dose and understand how the drug works alone and with decitabine. This study is sponsored by Bio-Path Holdings, Inc.

Who may be eligible for this acute myeloid leukemia clinical trial?

Adults aged 18 or older with refractory or relapsed AML are eligible, including those eligible for decitabine therapy. Participants must have good performance status and adequate liver and kidney function. Both men and women can join if they agree to use birth control. Please review eligibility criteria for more details.

Is there any cost to participate in this acute myeloid leukemia clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase 1

Age: 18Years +

All Genders

ID05190471

Phase IIb Study of BP1002 Liposomal Bcl-2 Antisense Drug for Adults With Relapsed or Refractory Acute Myeloid Leukemia AML Evaluating Safety and Effects of BP1002 Alone and With Decitabine

Led by Bio-Path Holdings, Inc. · Updated on 2025-03-10

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying BP1002, a liposomal Bcl-2 antisense oligodeoxynucleotide, to evaluate its safety, tolerability, and potential effects in patients with refractory or relapsed acute myeloid leukemia AML. This Phase IIb study aims to find dose-limiting toxicities, biologically effective doses, pharmacokinetics, pharmacodynamics, and possible anti-leukemic activity of BP1002 alone and in combination with decitabine. The study is sponsored by Bio-Path Holdings, Inc. The study has two parts a dose escalation phase where BP1002 is given alone at increasing doses, and a dose expansion phase where BP1002 is combined with decitabine. The dose escalation part evaluates BP1002 monotherapy, while the expansion part assesses the combination treatment. Participants receive the study drugs according to these protocols to determine safety and effective dose recommendations. Participants will undergo regular assessments including blood and bone marrow tests to monitor treatment effects and safety. Researchers will track adverse events, laboratory results, heart rhythms, drug levels in the blood, and immune responses. The study will also evaluate leukemia response indicators and survival outcomes over time. The total participation includes follow-up periods to monitor safety and treatment effects, lasting up to several months.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Adults 18 years of age or older with histologic evidence of refractory or relapsed AML who have failed available active treatments
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
For dose expansion phase, documented AML diagnosis and eligibility for decitabine therapy
Adequate liver function with AST and ALT less than or equal to 2.5 times the upper limit of normal
Total bilirubin usually less than or equal to 1.5 times the upper limit of normal or with medical waiver
Estimated creatinine clearance of at least 60 mL/min by Cockcroft-Gault equation
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 prior surgery, radiotherapy, or antineoplastic treatment effects except alopecia
Willing and able to provide written informed consent

You will not qualify if you...

Active non-hematologic or lymphoid malignancy other than AML treated with immunotherapy, targeted therapy, or chemotherapy within the last 12 months
Known active leptomeningeal leukemia requiring intrathecal therapy
Isolated extramedullary leukemia without meeting bone marrow criteria for acute leukemia unless approved
Acute promyelocytic leukemia with t(15;17)(q22;q12) PML-RARA
Chronic myeloid leukemia at any phase
Anti-cancer therapy within 14 days prior to first treatment day except hydroxyurea or leukapheresis
Receiving other investigational agents
Pregnant or breastfeeding females
Substance abuse or conditions interfering with participation or study evaluation
HIV infection with CD4+ T-cell counts below 350 cells/mcL or active hepatitis B or C infection
Hypersensitivity to hypomethylating agents unless deemed irrelevant
Unresolved toxicity higher than CTCAE Grade 1 from prior therapy except alopecia
Concurrent conditions compromising ability to tolerate treatment or study conduct including unstable angina, severe heart failure, uncontrolled hypertension, significant cardiac arrhythmia or ECG abnormalities
Recent major cardiovascular events within past 6 months
Uncontrolled seizure disorder within past 2 months
Unable or unwilling to communicate, cooperate, or follow protocol for any reason

Research Team

Michael Hickey

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Phase IIb Study of BP1002 Liposomal Bcl-2 Antisense Drug for Adults With Relapsed or Refractory Acute Myeloid Leukemia AML Evaluating Safety and Effects of BP1002 Alone and With Decitabine

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria