Actively Recruiting
Phase IIa Open-label Trial of BP1001 with Venetoclax Plus Decitabine in AML Patients Ineligible for Intensive Therapy
Led by Bio-Path Holdings, Inc. · Updated on 2025-03-07
108
Participants Needed
9
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of BP1001 plus venetoclax plus decitabine in adults with acute myeloid leukemia (AML) who cannot or choose not to receive intensive chemotherapy. The study aims to determine if this combination offers better results, such as complete remission, compared to venetoclax plus decitabine alone or to intensive chemotherapy in patients with untreated or relapsed/refractory AML. This Phase IIa trial focuses on patients who are fragile or ineligible for aggressive treatment, addressing a need for targeted therapies that may improve outcomes while being tolerable. Participants will receive one of three treatment combinations depending on their AML status: untreated patients receive BP1001 with venetoclax and decitabine; relapsed or refractory patients receive BP1001 with venetoclax and decitabine; and a third group of relapsed or refractory patients who are resistant or intolerant to venetoclax receive BP1001 plus decitabine. The study uses an open-label design and will enroll about 19 participants per cohort initially, with potential expansion based on interim data review. The treatment involves multiple drug administrations to assess safety, pharmacokinetics, pharmacodynamics, and efficacy. During the study, participants will undergo regular assessments including bone marrow biopsies or aspirates to measure treatment response over 180 days. Safety will be monitored through evaluations up to 30 days post-treatment, along with pharmacokinetic studies of BP1001. Researchers will also assess minimal residual disease status and overall survival. Participants must meet specific health criteria and will provide informed consent before enrollment. The study is sponsored by Bio-Path Holdings, Inc. and is expected to continue until December 2028.
CONDITIONS
Brief Title
Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- Females must be non-childbearing, surgically sterile, postmenopausal, or use effective contraception during and for 30 days after treatment
- Males must agree to use contraception during and for 30 days after treatment
- Diagnosed with newly diagnosed untreated AML, untreated secondary AML including progression from MDS, or relapsed/refractory AML
- Considered ineligible or unwilling to receive intensive induction therapy due to medical or disease factors
- Eligible for venetoclax and decitabine therapy as assessed by investigator
- White blood cell count of 25 x 10^9/L or less at study start
- Adequate liver function (AST and ALT ≤ 2.5 times upper limit of normal, total bilirubin usually ≤ 1.5 ULN)
- Estimated glomerular filtration rate (eGFR) of at least 40 ml/min
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Recovered from prior surgery, radiation, or antineoplastic treatments except alopecia
- Able and willing to provide written informed consent
You will not qualify if you...
- Active non-blood cancers treated with immuno- or chemotherapy within the last 12 months, except certain skin cancers
- Known active leptomeningeal leukemia requiring spinal fluid treatment
- Leukemia limited to outside bone marrow without marrow involvement
- Acute promyelocytic leukemia with specific genetic marker t(15;17)
- Chronic myeloid leukemia in any phase
- Received cancer treatment within 14 days before study start except permitted drugs
- Uncontrolled active or progressive infections
- Received investigational agents within 30 days before study start
- Females able to become pregnant, pregnant, or breastfeeding during screening or study
- Serious medical or psychiatric illnesses interfering with study completion
- Active hepatitis B, hepatitis C, or HIV infection
- Known allergies to venetoclax or decitabine
- Conditions that may affect ability to tolerate study treatment or study conduct, including certain heart problems
- Recent major cardiovascular events within 6 months
- Uncontrolled seizures within 2 months
- Cannot receive live vaccines during or after venetoclax treatment until immune recovery
- Unable or unwilling to cooperate with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 180 days
Participants receive BP1001 in combination with Venetoclax plus decitabine or BP1001 plus decitabine depending on their cohort assignment. Treatment continues until the end of the evaluation period or discontinuation.
Regular visits for treatment and monitoring during the treatment period
Duration - Up to 180 days
Participants are monitored for safety, efficacy, and overall survival after treatment completion.
Visits as scheduled for safety and efficacy assessments
Trial Site Locations
Total: 9 locations
1
UCLA Medical Center
Los Angeles, California, United States, 90095
Actively Recruiting
2
Georgia Cancer Center at Augusta University
Augusta, Georgia, United States, 30912
Actively Recruiting
3
University of Kansas Cancer Center
Fairway, Kansas, United States, 66205
Actively Recruiting
4
New Jersey Hematology Oncology Associates
Brick, New Jersey, United States, 08724
Terminated
5
Laura & Isaac Pe lmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
6
Weill Cornell Medical College - New York - Presbyterian Hospital
New York, New York, United States, 10021
Actively Recruiting
7
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
8
Baylor Scott & White Research Institute
Temple, Texas, United States, 76508
Terminated
9
West Virginia University/Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States, 26506
Terminated
Research Team
M
Maro Ohanian, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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