A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
NCT ID: NCT05190471
Last Updated: 2025-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
48 participants
INTERVENTIONAL
2022-08-16
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Relapsed/Refractory AML - BP1002 monotherapy
BP1002 monotherapy dose escalation
BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide
Dose escalation of BP1002 monotherapy
Relapsed/Refractory AML - BP1002 in combination with decitabine
BP1002 single dose in combination with decitabine
BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide
Dose escalation of BP1002 monotherapy
Decitabine (in combination with BP1002)
Dose expansion of BP1002 in combination with decitabine
Interventions
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BP1002; Liposomal Bcl-2 Antisense Oligodeoxynucleotide
Dose escalation of BP1002 monotherapy
Decitabine (in combination with BP1002)
Dose expansion of BP1002 in combination with decitabine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 or 2
3. For the dose expansion phase, participants with documented diagnosis of AML who are eligible for decitabine therapy
4. Participants must have adequate hepatic and renal functions as defined by:
1. Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and
2. Usually total bilirubin ≤ 1.5 ULN. In specific cases the PI may request a waiver of this requirement with medical justification and agreement with the medical monitor and Bio-Path Holdings. And;
3. Estimated creatinine clearance of at least 60 mL/min. These estimations are calculated using the Cockcroft-Gault equation.
5. Female participants of childbearing potential must agree to use an acceptable method of birth control (i.e. a hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) for the duration of the study and for at least 6 months after the last dose of study drug or decitabine
6. Male participants must agree to use an acceptable method of contraception for the duration of the study
7. Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment
8. Participants must be willing and able to provide written informed consent
Exclusion Criteria
2. Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Participants with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening
3. Isolated potentially treatable extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually ≥ 5% blasts in BMA or biopsy). Participants may have leukemia with lower blast counts (Döhner 2017). Bio-Path Holdings and Investigator concurrence required.
4. Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA
5. Chronic myeloid leukemia in any phase
6. Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or leukapheresis
7. Participants may not be receiving any other investigational agents
8. Female participants who are pregnant or breast-feeding
9. Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
10. Participants with human immunodeficiency virus (HIV) infection who have CD4+ T-cell counts \< 350 cells/mcL or with clinically active hepatitis B or C infection
11. History of any hypersensitivity to hypomethylating agents, unless reaction is deemed irrelevant to the study by the Investigator and Medical Monitor
12. Unresolved toxicity higher than CTCAE Grade 1 attributed to any prior therapy or procedure, excluding alopecia
13. Presence of concurrent conditions that, in the opinion of the Investigator and/or Medical Monitor, may compromise the participant's ability to tolerate study treatment or interfere with any aspect of study conduct or interpretation of results. This includes, but is not limited to, unstable or uncontrolled angina, New York Heart Association (NYHA) class III or IV congestive heart failure, uncontrolled and sustained hypertension, clinically significant cardiac dysrhythmia or clinically significant baseline ECG abnormality (e.g., QTcF \>470 msec)
14. Within the past 6 months, has had any of the following: myocardial infarction, unstable angina pectoris, coronary/peripheral artery bypass graft, cerebrovascular accident or transient ischemic attack
15. Uncontrolled seizure disorder (i.e., seizures within the past 2 months)
16. Unable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reason
18 Years
ALL
No
Sponsors
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Bio-Path Holdings, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gail J Roboz, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Cornell Medical College - New York-Presbyterian Hospital
Locations
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Scripps Green Hospital
La Jolla, California, United States
UCLA Medical Center
Los Angeles, California, United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Gary Schiller, MD
Role: primary
Other Identifiers
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BP1002-102-AML
Identifier Type: -
Identifier Source: org_study_id
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