Clinical trial for Acute Myeloid Leukemia
Official title Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
ClinicalTrials.gov ID: NCT05554406
What this study is testing
What is Azacitidine?
Azacitidine is an investigational medicine being studied as a potential treatment for high-risk acute myeloid leukemia. It is designed to help the bone marrow produce normal blood cells and kill abnormal cells.
Also referred to as Vidaza, Mylosar, 5-Azacitidine.
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
- The study compares the standard cytarabine and daunorubicin treatment to four experimental regimens to see if they can shrink the cancer more effectively.
- Who it's for
- It is looking for adults who have just been diagnosed with high‑risk acute myeloid leukemia and have not yet started treatment.
- What's involved
- Participants will receive one of the five treatment options, which include different combinations of cytarabine, daunorubicin, a liposome form of daunorubicin, azacitidine, and venetoclax, and will have regular blood tests and visits to monitor response.
- Time commitment
- The trial lasts several months, with frequent clinic visits and blood tests during the treatment period and follow‑up to track outcomes.
- 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
- Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study.
- 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...
See the full eligibility criteria
- Participants must have been registered to Master Screening and Re-Assessment Protocol, MYELOMATCH, prior to consenting to this study.
- 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-unless...
- Acute promyelocytic leukemia is excluded
- Participants with favorable or intermediate risk disease per ELN 2017 criteria 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 for AML is allowed prior to study entry
- Prior anthracycline therapy for any indication is allowed but must not exceed a cumulative lifetime dose of 200 mg/m\^2 daunorubicin or equivalent
- Participants must not have received or be currently receiving any prior therapy for acute myeloid leukemia.
- 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 complete medical history and physical exam (H\&P) completed 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 a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at time of registration and have undetectable HIV viral load on the most recent test results...
- Participants with a known history 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 known history of hepatitis C virus (HCV) infection must have been treated and cured.
- 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 7 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 7 days prior to registration- unless...
- 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 central nervous system (CNS) disease are eligible for this trial and will be treated according to institutional guidelines with intrathecal chemotherapy for this aspect of their disease.
- 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.
- Participants must have agreed to have specimens submitted for translational medicine (MRD) under MYELOMATCH and specimens must be submitted
- Participants must be offered the opportunity to participate in specimen banking
- Note: Specimens must be collected and submitted using the Southwest Oncology Group (SWOG) Specimen Tracking System
- 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
- For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and...
- 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 is enrolling
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Oakland, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Francisco, California, United States
- Santa Clara, 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
+ 156 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, but 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?
This study is enrolling now at Birmingham, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Oakland, California, United States and 170 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.