Actively Recruiting
Phase II Study of Venetoclax With Alternative Hypomethylating Agent for Patients With Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
Led by Brian Jonas · Updated on 2024-05-29
20
Participants Needed
4
Research Sites
30 weeks
Total Duration
On this page
Sponsors
B
Brian Jonas
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of azacitidine or decitabine with venetoclax in patients with acute myeloid leukemia (AML) who have either not been treated before or whose disease has returned. This phase II trial focuses on patients who have previously failed treatment with hypomethylating agents (HMA) and aims to assess overall response rates, additional measures of effectiveness, and safety of this combination therapy. Participants receive azacitidine intravenously or subcutaneously on days 1 to 7 if they previously used decitabine, or decitabine intravenously on days 1 to 5 if they previously used azacitidine. Venetoclax is taken orally every day for 28 days. These treatment cycles repeat every 28 days as long as the disease does not progress or unacceptable side effects do not occur. During the study, participants undergo evaluations including response assessments up to one year, monitoring of minimal residual disease, rates of remission, transfusion independence, survival measures, and adverse events. Safety and treatment effects are closely monitored throughout the study period to better understand the impact of this combination therapy in AML patients with prior HMA failure.
CONDITIONS
Brief Title
Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and willingness to sign informed consent
- Diagnosis of acute myeloid leukemia by WHO 2016 criteria
- Age 18 years or older
- Treatment naive and eligible for venetoclax plus hypomethylating agent with prior HMA failure
- Prior exposure to decitabine and/or azacitidine for antecedent hematologic disorder
- Prior allogeneic hematopoietic transplant allowed if done at least 3 months prior without active graft versus host disease or systemic immune suppression
- ECOG performance status 0 to 2 for patients 75 years or older, or 0 to 3 for patients aged 18 to 74
- White blood cell count of at least 25,000/mm3 at treatment start (leukapheresis and hydroxyurea allowed)
- Total bilirubin less than or equal to 1.5 times institutional upper limit of normal unless related to AML or Gilbert's syndrome
- AST and ALT less than or equal to 3 times institutional upper limit of normal unless related to AML
- Creatinine clearance at least 30 mL/min
- Women of child-bearing potential and men with partners of child-bearing potential agree to use adequate contraception during and 90 days after study
- Negative pregnancy test for women of child-bearing potential
- Ability to swallow and retain oral medication
You will not qualify if you...
- Use of other investigational agents within 14 days or 5 half-lives prior to first dose and during venetoclax treatment
- Diagnosis of acute promyelocytic leukemia
- Active central nervous system involvement by AML
- Anticancer therapies including chemotherapy, targeted agents, or radiotherapy within 14 days or 5 half-lives prior to first dose and during venetoclax treatment
- Prior therapy with venetoclax
- Known HIV infection or active hepatitis A, B, or C infection without undetectable viral load and adequate immune status
- Use of strong or moderate CYP3A inducers within 7 days prior to study treatment
- Consumption of grapefruit or related products within 3 days prior to study treatment
- Severe or uncontrolled medical disorders impairing ability to receive study treatment
- History of other malignancies unless treated with curative intent and no active disease for at least 1 year
- Evidence of uncontrolled active systemic infection requiring therapy
- History of allergic reactions to similar compounds
- Malabsorption syndrome or other condition preventing oral medication absorption
- Cardiovascular disability greater than New York Heart Association class 2
- Pregnant or nursing women
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 - Repeated 28-day cycles until disease progression or unacceptable toxicity
Participants receive azacitidine IV or subcutaneously on days 1 to 7 or decitabine IV on days 1 to 5, along with venetoclax taken orally daily on days 1 to 28. Treatment cycles repeat every 28 days if there is no disease progression or unacceptable toxicity.
Monthly visits every 28 days during treatment cycles
Trial Site Locations
Total: 4 locations
1
UCSF-Fresno
Clovis, California, United States, 93611
Actively Recruiting
2
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
3
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
4
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here