Your session is about to expire
← Back to Search
Anti-cancer peptide
BP1001 + Venetoclax + Decitabine for Acute Myeloid Leukemia
Phase 2
Recruiting
Led By Maro Ohanian, DO
Research Sponsored by Bio-Path Holdings, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Documented Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Histologically documented diagnosis of newly diagnosed untreated AML, untreated secondary AML, relapsed or refractory AML
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 180 days
Awards & highlights
Study Summary
This trial is testing whether a combination of three drugs is more effective at treating acute myeloid leukemia than two drugs. The three drugs are: BP1001, venetoclax, and decitabine. The trial is also testing whether BP1001 is more effective than intensive chemotherapy in treating relapsed or refractory AML.
Who is the study for?
Adults over 18 with untreated Acute Myeloid Leukemia (AML) or relapsed/refractory AML, who can't or choose not to undergo intensive chemotherapy. Participants must have proper liver and kidney function, an ECOG performance status of 0-2, and agree to use contraception. Excluded are those with active leptomeningeal leukemia, recent anti-cancer therapy, potential pregnancy/breastfeeding during the study period, significant concurrent illnesses or infections.Check my eligibility
What is being tested?
The trial is testing BP1001 in combination with venetoclax plus decitabine against historical data for efficacy in achieving complete remission in AML patients. It aims to determine if this new treatment combo is more effective than existing treatments for those who cannot receive intensive chemotherapy.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system's response to BP1001, issues from venetoclax such as gastrointestinal symptoms and low blood cell counts leading to increased infection risk, and decitabine-related side effects like fatigue and liver enzyme changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I have a confirmed diagnosis of AML that is new, untreated, relapsed, or refractory.
Select...
I am eligible for treatment with venetoclax and decitabine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 180 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~180 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of efficacy in refractory/relapsed AML subjects by bone marrow aspirate or biopsy
Assessment of efficacy in untreated AML subjects by bone marrow aspirate or biopsy
Secondary outcome measures
Assessment of Minimal Residual Disease (MRD) status in patients who achieve CR/CRi/CRh with BP1001-based treatment
Assessment of Partial Remissions and blast count reductions.
Assessment of overall survival
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Untreated AMLExperimental Treatment1 Intervention
BP1001 in combination with Ventoclax plus decitabine
Group II: Refractory/Relapsed AML (ventoclax-intolerant or resistant)Experimental Treatment1 Intervention
BP1001 + decitabine combination in patients who are resistant or intolerant of venetoclax-based treatment, or considered not optimal candidates for a venetoclax-based therapy.
Group III: Refractory/Relapsed AMLExperimental Treatment1 Intervention
BP1001 in combination with Ventoclax plus decitabine
Find a Location
Who is running the clinical trial?
Bio-Path Holdings, Inc.Lead Sponsor
5 Previous Clinical Trials
188 Total Patients Enrolled
Maro Ohanian, DOPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself and am up and about more than half of my waking hours.I have leukemia in the fluid around my brain and need spinal injections.I have recovered from any side effects of my previous cancer treatments.I have not had a heart attack, stroke, or similar event in the last 6 months.I haven't had cancer treatment except for skin cancer in the last year.My leukemia is present outside the bone marrow without meeting the criteria for acute leukemia in the bone marrow.I am not pregnant, trying to get pregnant, or breastfeeding.I have seizures that are not controlled by medication.I am willing and able to follow study instructions.I cannot have live vaccines before, during, or after my venetoclax treatment.I agree to use contraception during and for 30 days after the study.I have a confirmed diagnosis of AML that is new, untreated, relapsed, or refractory.I do not have any serious ongoing health or mental health issues.I do not have any untreated or uncontrolled infections.I haven't had cancer treatment in the last 14 days, with some exceptions.I am not able to have children, have been surgically sterilized, am postmenopausal, or will use birth control during and for 30 days after the study.My leukemia is specifically diagnosed as APL with a certain genetic feature.My liver and kidney functions are normal.I have chronic myeloid leukemia.I am not a candidate for or am unwilling to undergo intensive therapy for my condition as per my doctor's advice.I am eligible for treatment with venetoclax and decitabine.I am 18 years old or older.I do not have active hepatitis B or C, or HIV.
Research Study Groups:
This trial has the following groups:- Group 1: Refractory/Relapsed AML (ventoclax-intolerant or resistant)
- Group 2: Untreated AML
- Group 3: Refractory/Relapsed AML
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger