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New treatment option for Acute Myeloid Leukemia
Official title Testing the Effects of Novel Therapeutics for Newly Diagnosed, Untreated Patients With High-Risk Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
ClinicalTrials.gov ID: NCT05554406
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine, given as an injection under the skin, 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 MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine liposome and venetoclax. "High-risk" refers to traits that have been known to make the AML harder to treat.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 59
You may be able to join if
- STEP 1 REGISTRATION:
- Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants...
- Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH
- Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria
- Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criteria
See the full eligibility criteria
- STEP 1 REGISTRATION:
- Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study. Participants must have been assigned to this clinical trial, via MATCHBox, prior to...
- Note: Pre-enrollment/diagnosis labs must have already been performed under MYELOMATCH
- Participants must have newly diagnosed, untreated acute myeloid leukemia (AML) per World Health Organization (WHO) criteria
- Participants must have high-risk (adverse) AML per European LeukemiaNet (ELN) 2017 criteria
- Participants with therapy-related AML (t-AML), or with AML evolving from an antecedent hematologic disorder (such as myeloproliferative neoplasm), or AML with myelodysplasia-related changes (AML-MRC) are eligible
- Acute promyelocytic leukemia is excluded
- Participants with favorable or intermediate risk disease are excluded
- Participants with FLT3 mutations (ITD or TKD) are excluded
- Participants with t(9;22) translocation are excluded
- A single dose of intrathecal chemotherapy is allowed prior to study entry
- Prior anthracycline therapy is allowed but must not exceed a cumulative lifetime dose of 200 mg/m\^2 daunorubicin or equivalent. Prior hypomethylating agent (HMA) exposure is allowed, as long as not for AML diagnosis
- Participants must not have received or be currently receiving any prior therapy for acute myeloid leukemia. Hydroxyurea to control the white blood cells (WBC) is allowed prior to registration and initiation of...
- Participants must not be receiving or planning to receive any other investigational agents before completing protocol therapy
- Participants must be between 18 and 59 years of age
- Participants must have Zubrod performance status =\< 3 as determined by a history and physical (H\&P) completed within 14 days prior to registration
- Participants must have a complete medical history and physical exam within 7 days prior to registration
- Participants must be able to swallow and retain oral medications and have no known gastrointestinal disorders likely to interfere with absorption of oral medications
- Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load within 6 months prior to registration
- Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load within 28 days prior to registration and be on suppressive therapy, if indicated
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants with active HCV infection who are currently on treatment must have an undetectable HCV viral load within 28...
- The following tests must be performed within 14 days prior to registration to establish baseline values:
- Complete blood count (CBC)/differential/platelets
- Total bilirubin
- Lactate dehydrogenase (LDH)
- Albumin
- Glucose
- Fibrinogen
- Participants must have adequate kidney function as evidenced by creatinine clearance \>= 30mL/min (by Cockcroft Gault) within 28 days prior to registration
- Participants must have adequate liver function as evidenced by aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 3.0 x upper limit of normal (ULN) within 28 days prior to registration
- Total bilirubin =\< 2.0 x ULN (or 5.0 x ULN if the participant has a history of Gilbert's disease) within 28 days prior to registration
- Participants must have adequate cardiac function as determined by echocardiography or MUGA scan with an ejection fraction \>= 50% within 28 days prior to registration
- Participants with a prior or concurrent malignancy whose natural history (in the opinion of the treating physician) does not have the potential to interfere with the safety or how well it works assessment of the...
- Participants with known history of Wilson's disease or other known copper-metabolism disorder are excluded
- Participants must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use 2 contraception methods. A woman is considered to be of "reproductive potential" if she has had menses at any...
- Participants must have agreed to have specimens submitted for translational medicine (MRD) under the myeloMATCH MSRP and specimens must be submitted
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Berkeley, California, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- San Mateo, California, United States
- New Haven, Connecticut, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Pembroke Pines, Florida, United States
- Albany, Georgia, United States
- Augusta, Georgia, United States
- Honolulu, Hawaii, United States
- ‘Aiea, Hawaii, United States
- Boise, Idaho, United States
- Caldwell, Idaho, United States
- Coeur d'Alene, Idaho, United States
+ 163 more site(s).
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 to 59 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Berkeley, California, United States; Los Angeles, California, United States and 177 more location(s). 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.