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New treatment option for Acute Myeloid Leukemia
Official title Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
ClinicalTrials.gov ID: NCT04905810
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as 5 AZC, 5-AC.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patient experienced HMA failure for an antecedent hematologic disorder (e.g. myelodysplastic syndrome) prior to study entry (Santini 2019), defined...
You likely can't join if
- Current or anticipated use of other investigational agents within 14 days or 5 half-lives (whichever is shorter) prior to the first dose and...
- 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...
- 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...
See the full eligibility 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 \ \...
- 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...
- 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...
- ECOG performance status of: \ 0 to 2 for people \>= 75 years of age OR \ 0 to 3 for people \>= 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 (people 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...
- Women of child-bearing potential has negative pregnancy test prior to initiating study drug dosing
- Able to swallow and retain oral medication
- 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...
- 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...
- 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...
- 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
- people 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
The study team makes the final eligibility decision.
Where it's taking place
- Clovis, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Oklahoma City, Oklahoma, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clovis, California, United States; Los Angeles, California, United States; Sacramento, California, United States; Oklahoma City, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.