NCT04905810 · Brian Jonas
Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
What this study is about
This phase II trial evaluates the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before (treatment naive) or has come back (relapsed).
View original scientific description
This phase II trial evaluates the effect of azacitidine or decitabine and venetoclax in treating patients with acute myeloid leukemia that has not been treated before (treatment naive) or has come back (relapsed). Chemotherapy drugs, such as azacitidine, decitabine, and venetoclax, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Interventions
DRUG
Azacitidine
Given IV
DRUG
Decitabine
Given IV
DRUG
Venetoclax
Given PO
Primary outcome measures
Overall response rate
Time frame: Up to 1 year
Will be defined as the rate of complete remission (CR) plus CR with incomplete count recovery (CRi).
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
- Ability to understand and the willingness to sign a written informed consent
- Diagnosis of AML by World Health Organization (WHO) 2016 criteria (Arber 2016)
- Age \>= 18 years
- Treatment naïve and eligible for venetoclax plus HMA: \
- Age \>= 75 OR \
- Age \>= 18-74 with at least one of the following co-morbidities: \*\
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3 \*\
- Cardiac history of chronic heart failure (CHF) requiring treatment or left ventricular ejection fraction (LVEF) =\< 50% or chronic unstable angina \*\
- Carbon monoxide diffusing capability (DLCO) =\< 65% or forced expiratory volume in 1 second (FEV1) =\< 65% \*\
- Creatinine clearance \>= 30 mL/min to =\< 45 mL/min \*\
- Moderate hepatic impairment with total bilirubin \> 1.5 to =\< 3 x upper limit of normal (ULN) \*\
- Any other situation that the investigator judges to be incompatible with intensive chemotherapy must be reviewed with the study chair before study enrollment
Where
- Clovis, California
- Los Angeles, California
- Sacramento, California
- Oklahoma City, Oklahoma
Collaborators
AbbVie, National Cancer Institute (NCI)
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 May 29, 2024 · Source of record for eligibility and locations