NCT02781883 · Bio-Path Holdings, Inc.
Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML
What this study is about
The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater effectiveness (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
View original scientific description
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
Interventions
DRUG
BP1001 in combination with Ventoclax plus decitabine
BP1001 in combination with Ventoclax plus decitabine
DRUG
BP1001 plus decitabine
BP1001 plus decitabine in ventoclax intolerant or resistant subjects
Primary outcome measures
Assessment of efficacy in untreated AML subjects by bone marrow aspirate or biopsy
Time frame: 180 days
Assess whether the combination of BP1001 and Ventoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than Ventoclax + decitabine alone (by historical comparison) with untreated AML that cannot or elect not to be treated with more intensive chemotherapy
Assessment of efficacy in refractory/relapsed AML subjects by bone marrow aspirate or biopsy
Time frame: 180 days
Assess whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- At the time of Screening, participants must meet all of the following criteria to be considered eligible to participate in the study: 1. Adults ≥18 years of age 2. Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study and for 30 days after the last dose of study drug or decitabine 3. Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or decitabine 4. Histologically documented diagnosis (based on the 2008 World Health Organization \[WHO\] Classification) (Vardiman et al. 2009) of one of the following: 1. Newly diagnosed untreated AML; or 2. Untreated secondary AML, including AML that has progressed from MDS 3. In some cases of AML associated with specific genetic abnormalities, however, the diagnosis of AML may be made if the blast count is less than 20% (Dohner et al. 2017) - speci
Where
- Los Angeles, California
- Augusta, Georgia
- Fairway, Kansas
- Brick, New Jersey
- New York, New York
- Houston, Texas
- Temple, Texas
- Morgantown, West Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 7, 2025 · Source of record for eligibility and locations