Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
Phase II Study of Venetoclax With Alternative Hypomethylating Agent for Patients With Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure: A University of California Hematologic Malignancies Consortium Protocol
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This phase II study tests azacitidine or decitabine with venetoclax for acute myeloid leukemia (AML), a blood cancer. It is for adults whose earlier blood disease did not improve or got worse after azacitidine or decitabine. The study overview mentions new or returning AML, but the entry rules require AML that has not yet been treated.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older, have AML, and be able to understand and sign a consent form.
- Have had azacitidine or decitabine for an earlier blood disease. The disease must have stayed the same or worsened after at least 4 treatment cycles, or 2 cycles with other drugs, or returned or worsened after first improving.
- Have no prior treatment for AML. Be age 75 or older, or age 18–74 with certain health problems that make strong chemotherapy unsuitable.
- Meet the study’s limits for daily activity, blood cell counts, and liver and kidney tests. Activity limits depend on age.
- A prior donor stem cell transplant for the earlier blood disease is allowed if it was at least 3 months ago. There must be no active donor cells attacking the body and no need for drugs that weaken the immune system throughout the body.
- Be able to swallow and keep down medicine taken by mouth.
- If you or your partner could become pregnant, agree to use birth control before and during treatment and for 90 days afterward.
- If you could become pregnant, have a negative pregnancy test before starting study drugs.
Who can't join
- Have acute promyelocytic leukemia, a certain type of AML, or AML that is active in the brain or spinal cord.
- Have taken venetoclax before, or have recent or planned use of other study drugs or cancer treatments during the study’s restricted times.
- Have HIV or active hepatitis A, B, or C unless the study’s virus and immune cell rules are met. People with hepatitis C must have completed treatment to cure it.
- Have used certain drugs that affect how the body processes study treatment within 7 days, or eaten grapefruit, Seville oranges, or starfruit within 3 days before treatment.
- Have a severe or uncontrolled illness, an uncontrolled infection needing treatment, major heart-related limits on activity, or mental health or social problems that would prevent following study rules.
- Have another cancer, unless it meets an allowed exception, such as cancer treated to cure it with no active disease for at least 1 year, treated non-melanoma skin cancer, or cured, localized prostate or cervical cancer.
- Have an allergy to drugs similar to the study drugs, or a condition that prevents taking or absorbing medicine through the digestive tract.
- Be pregnant or breastfeeding.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 * Patient experienced HMA failure for an antecedent hematologic disorder (e.g. myelodysplastic syndrome) prior to study entry (Santini 2019), defined as: \* Disease progression or stable disease as best response to \>= 4 cycles of HMA or \>= 2 cycles of HMA combination therapy (primary resistance) OR \* Relapse or progression after prior response to HMA (secondary resistance) * Prior decitabine and/or azacitidine, including oral formulations, for antecedent hematologic disorder is required. The patient should be treatment naïve for the AML diagnosis * Prior allogeneic hematopoietic transplant for antecedent hematologic disorder is allowed if done at least 3 months prior to enrollment and there is no evidence of active graft versus host disease (GVHD) or requirement for systemic immune suppression * ECOG performance status of: \* 0 to 2 for subjects \>= 75 years of age OR \* 0 to 3 for subjects \>= 18-74 years of age * Whole blood cell (WBC) \>= 25,000/mm\^3 at the start of study therapy (leukapheresis and hydroxyurea areallowed to meet this criteria) * Total bilirubin =, 1.5 x institution's ULN unless related to AML or Gilbert's syndrome (subjects who are \>= 18-74 may have a total bilirubin of =\< 3 x institution's ULN) * Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SPGT) =\< 3 x institutional ULN unless related to AML * Creatinine clearance \>= 30 mL/min (calculated by the Cockcroft Gault formula or measured by 24-hours urine collection) * Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. \* A woman of child-bearing potential is any female (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria: \*\* Has not undergone a hysterectomy or bilateral oophorectomy; or \*\* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months) * Women of child-bearing potential has negative pregnancy test prior to initiating study drug dosing * Able to swallow and retain oral medication Exclusion Criteria: * Current or anticipated use of other investigational agents within 14 days or 5 half-lives (whichever is shorter) prior to the first dose and throughout venetoclax administration * Diagnosis of acute promyelocytic leukemia * Active central nervous system involvement by AML * Anticancer therapies, including investigational therapy, chemotherapy, targeted small molecule agents, or radiotherapy within 14 days or 5 half-lives (whichever is shorter) prior to the first dose and throughout venetoclax administration. Biologic agents (e.g. monoclonal antibodies) given for anti-neoplastic intent within 30 days prior to the first dose and throughout venetoclax administration * Prior therapy with venetoclax * Known diagnosis of human immunodeficiency virus (HIV) infection or known active hepatitis A, B or C infection with the exception of those with an undetectable viral load and CD4+ T-cell (CD4+) counts \>= 350 cells/μL within 3 months of starting study treatment. Should have no titers within 28d of day 1. Patients with hepatitis C virus (HCV) infection should have completed curative antiviral treatment * Known strong and/or moderate CYP3A inducers within 7 days prior to the initiation of study treatment * Subject has consumed grapefruit, grapefruit products, Seville oranges or starfruit within 3 days prior to the initiation of study treatment * Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements) * History of other malignancies, except for malignancy treated with curative intent with no known active disease present for \>= 1 year; treated non-melanoma skin cancer; and localized, cured prostate and cervical cancer * Evidence of uncontrolled active systemic infection requiring therapy (viral, bacterial, or fungal). Fever of unknown origin is not an exclusion criterion, as this may be disease related * History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in study * Subject has a malabsorption syndrome of other condition that precludes enteral route of administration * Subjects with a cardiovascular disability status of New York Heart Association class greater than 2 * Pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants
Study sites (4)
CA
- UCSF-Fresno · Clovis, CA 93611Mohammed Bukari, MD · Study contact · 559-387-1900 ext. 41936 · mohammed.bukari@ucsf.eduMohammed Bukari, MD · Principal investigatorMore trials in Clovis
- UCLA / Jonsson Comprehensive Cancer Center · Los Angeles, CA 90095Caspian Oliai · Study contact · 310-206-6909 · COliai@mednet.ucla.eduCaspian Oliai · Principal investigatorMore trials in Los Angeles
- University of California Davis Comprehensive Cancer Center · Sacramento, CA 95817Brian A. Jonas · Study contact · 916-734-3771 · bajonas@ucdavis.eduBrian A. Jonas · Principal investigatorMore trials in Sacramento
OK
- University of Oklahoma Health Sciences Center · Oklahoma City, OK 73104Matthew J. Wieduwilt · Study contact · 405-217-8001 · Matthew-Wieduwilt@ouhsc.eduMatthew J. Wieduwilt · Principal investigatorMore trials in Oklahoma City