Acute Myeloid Leukemia, in Relapse study: Decitabine
Official title A Clinical Trial of BP1002 in Patients With Refractory/Relapsed Acute Myeloid Leukemia (AML)
ClinicalTrials.gov ID: NCT05190471
What this study is testing
What is BP1002?
BP1002 is an investigational injectable medicine being studied as a potential treatment for relapsed or refractory acute myeloid leukemia. It is designed to bind to Bcl-2 messenger RNA and reduce production of the Bcl-2 protein that helps leukemia cells survive.
Also referred to as Liposomal Bcl-2; L-Bcl-2.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find the safest dose of BP1002 and see if it helps fight the leukemia when used alone or with another drug called decitabine.
- Who it's for
- The study is looking for adults with acute myeloid leukemia that has come back or has not responded to previous treatments.
- What's involved
- Participants will receive BP1002 through an IV (a tube into a vein) and may also take decitabine. They will have regular blood tests and medical checkups to monitor how their body reacts to the drug.
- Time commitment
- The study involves multiple visits to the clinic for treatment and testing, with the duration depending on how the participant responds to the drug.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults ≥18 years of age, with histologic evidence of refractory/relapsed AML who have failed treatment with available therapies known to be active...
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 or 2
- For the dose expansion phase, participants with documented diagnosis of AML who are eligible for decitabine therapy
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and
- Usually total bilirubin ≤ 1.5 ULN. In specific cases the PI may request a waiver of this requirement with medical justification and agreement with...
You likely can't join if
- Active non-hematologic or lymphoid malignancy other than AML treated with immunotherapy, targeted therapy or chemotherapy within the previous 12...
- Known, active leptomeningeal leukemia requiring intrathecal therapy.
- Isolated potentially treatable extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually ≥ 5% blasts in...
- Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA
- Chronic myeloid leukemia in any phase
- Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or leukapheresis
See the full eligibility criteria
- Adults ≥18 years of age, with histologic evidence of refractory/relapsed AML who have failed treatment with available therapies known to be active for refractory/relapsed AML
- Eastern Cooperative Oncology Group (ECOG) Performance Status Score of 0, 1 or 2
- For the dose expansion phase, participants with documented diagnosis of AML who are eligible for decitabine therapy
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 times the upper limit of normal (ULN); and
- 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;
- Estimated creatinine clearance of at least 60 mL/min. These estimations are calculated using the Cockcroft-Gault equation.
- Female participants of childbearing potential must agree to use an acceptable method of birth control (i.e.
- Male participants must agree to use an acceptable method of contraception for the duration of the study
- Recovered from the effects of any prior surgery, radiotherapy, or antineoplastic treatment (with the exception of alopecia), based on Investigator assessment
- Participants must be willing and able to provide written informed consent
- Active non-hematologic or lymphoid malignancy other than AML treated with immunotherapy, targeted therapy or chemotherapy within the previous 12 months
- 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...
- Isolated potentially treatable extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually ≥ 5% blasts in BMA or biopsy).
- Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA
- Chronic myeloid leukemia in any phase
- Receipt of any anti-cancer therapy within 14 days prior to C1D1, with the exception of hydroxyurea or leukapheresis
- Participants may not be receiving any other investigational agents
- Female participants who are pregnant or breast-feeding
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
- 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
- History of any hypersensitivity to hypomethylating agents, unless reaction is deemed irrelevant to the study by the Investigator and Medical Monitor
- Unresolved toxicity higher than CTCAE Grade 1 attributed to any prior therapy or procedure, excluding alopecia
- 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...
- 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
- Uncontrolled seizure disorder (i.e., seizures within the past 2 months)
- Unable or unwilling to communicate or cooperate with the Investigator or follow the protocol for any reason
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
- Los Angeles, California, United States
- New York, New York, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States; Los Angeles, California, United States; New York, New York, United States; Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.