Actively Recruiting
Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML
Led by Bio-Path Holdings, Inc. · Updated on 2025-03-07
108
Participants Needed
9
Research Sites
656 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.
CONDITIONS
Official 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 the study and for 30 days after last dose
- Males must use effective contraception during the study and for 30 days after last dose
- Diagnosed with newly diagnosed untreated AML, untreated secondary AML including AML progressed from MDS, AML with specific genetic abnormalities even if blast count is below 20%, or relapsed/refractory AML
- Considered ineligible or unwilling for intensive induction therapy due to medical reasons, disease characteristics, or patient choice
- Eligible for venetoclax and decitabine therapy based on Investigator assessment
- White blood cell count at study start is 25 x 10^9/L or less (leukapheresis or hydroxyurea allowed before treatment to achieve this)
- Adequate liver and kidney function (AST and ALT ≤2.5 times upper limit of normal, total bilirubin usually ≤1.5 times upper limit, estimated glomerular filtration rate at least 40 ml/min)
- ECOG performance status of 0, 1, or 2
- Recovered from effects of prior surgery, radiotherapy, or antineoplastic treatment (except alopecia)
- Able and willing to provide written informed consent
You will not qualify if you...
- Active non-blood or lymphoid cancer other than AML treated with chemotherapy or immunotherapy within the last 12 months (except certain skin cancers)
- Known active leptomeningeal leukemia requiring intrathecal therapy (patients with prior central nervous system disease may be allowed if spinal fluid test is negative within 28 days before screening)
- Leukemia only outside the bone marrow without meeting acute leukemia bone marrow criteria
- Acute promyelocytic leukemia with t(15;17)(q22;q12) PML-RARA
- Any phase of chronic myeloid leukemia
- Received any anti-cancer therapy within 14 days before first treatment day except certain medications
- Uncontrolled active or progressive infection
- Received investigational treatment within 30 days before first treatment day
- Females able to become pregnant who are pregnant, breastfeeding, or planning pregnancy during the study or 30 days after last dose
- Serious medical or psychiatric illness interfering with study participation
- Known active or significant hepatitis B, hepatitis C, or HIV infection
- History of allergic reaction to venetoclax or decitabine unless deemed irrelevant
- Conditions compromising ability to tolerate study treatment or affecting study conduct (including serious heart conditions and uncontrolled hypertension)
- Recent major cardiovascular events within past 6 months
- Uncontrolled seizure disorder with recent seizures
- Cannot receive live vaccines until immune recovery
- Unable or unwilling to communicate or cooperate with study requirements
AI-Screening
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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
CONTACT
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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