Trial comparing treatments for Acute Myeloid Leukemia
Official title Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A MyeloMATCH Treatment Trial)
ClinicalTrials.gov ID: NCT07437950
What this study is testing
What is Decitabine and Cedazuridine?
Decitabine and Cedazuridine is an investigational medicine, taken by mouth once daily, being studied as a potential treatment for acute myeloid leukemia.
Also referred to as ASTX 727, ASTX-727.
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 wants to see if a shorter course of venetoclax works as well as the usual longer course when given together with ASTX727.
- Who it's for
- Older patients who have just been diagnosed with acute myeloid leukemia.
- What's involved
- Participants will receive the oral drug venetoclax and the IV/ oral combo ASTX727 (decitabine plus cedazuridine) for either a standard or a shorter time, and will have clinic visits and lab tests to monitor safety and response.
- Time commitment
- Treatment lasts several weeks, with multiple clinic visits and follow‑up appointments over a few months.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
- 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 60 and older
You may be able to join if
- Participants must have been registered to the MYELOMATCH Master Screening and Reassessment Protocol 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) defined by
- Having ≥ 20% blasts in the bone marrow and/or peripheral blood or
- Having recurrent AML-specific genetic abnormalities with ≥ 10% blasts in the bone marrow aspirate and/or peripheral blood
See the full eligibility criteria
- Participants must have been registered to the MYELOMATCH Master Screening and Reassessment Protocol 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) defined by
- Having ≥ 20% blasts in the bone marrow and/or peripheral blood or
- Having recurrent AML-specific genetic abnormalities with ≥ 10% blasts in the bone marrow aspirate and/or peripheral blood
- Participants with acute promyelocytic leukemia (APL) with PML-RARA are not eligible
- Participants must not have FLT3 mutations (ITD or TKD)
- Participants must not have TP53 mutations
- Participants must not be receiving or planning to receive any other investigational agents while on protocol therapy
- Participants must not have received prior therapy for AML, myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) with the exception of hydroxyurea, all-trans retinoic acid (ATRA), BCR-ABL directed tyrosine...
- Note: White blood cell (WBC) must be \< 25 x 10\^9/L prior to start of treatment. Hydroxyurea, leukapheresis, and cytarabine ≤ 1g/m2 are permitted to control the WBC prior to enrollment and initiation of...
- Participant must be ≥ 60 years old at the time of registration
- Participant must have been declared unfit for intensive therapy by the treating physician at the time of registration to MYELOMATCH
- Participant must have Zubrod Performance Status of 0-3 within 28 days prior to registration
- Participant must have a complete medical history and physical exam within 28 days prior to registration
- Total bilirubin ≤ 3 x institutional upper limit of normal (ULN) unless history of Gilbert's disease.
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 x institutional ULN, unless considered elevated due to disease involvement (within 28 days prior to registration)
- Participants must have a calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been drawn and processed within 28 days prior to registration.
- Participants must have adequate cardiac function. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac...
- Participants with a known history of human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results...
- Participants with a known history of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to...
- Participants with a known history of hepatitis C virus (HCV) infection must have been treated and cured.
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or how well it works assessment of...
- Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped).
- 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 must have agreed to have specimens submitted for translational medicine for MRD under MYELOMATCH.
- Enrollment to this treatment study requires prior enrollment into the myeloMATCH Master Protocol (MYELOMATCH).
- In addition to the MYELOMATCH specimens, there will be specimens obtained on treatment for this substudy.
- Participants must be offered the opportunity to participate in specimen banking
- NOTE: As a part of the 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 approval for this study has been...
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Coeur d'Alene, Idaho, United States
- Post Falls, Idaho, United States
- Sandpoint, Idaho, United States
- Bloomington, Illinois, United States
- Canton, Illinois, United States
- Carthage, Illinois, United States
- Chicago, Illinois, United States
- Decatur, Illinois, United States
- Eureka, Illinois, United States
- Galesburg, Illinois, United States
- Kewanee, Illinois, United States
- Macomb, Illinois, United States
- New Lenox, Illinois, United States
- O'Fallon, Illinois, United States
- Orland Park, Illinois, United States
- Ottawa, Illinois, United States
- Pekin, Illinois, United States
- Peoria, Illinois, United States
- Peru, Illinois, United States
- Princeton, Illinois, United States
+ 34 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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Coeur d'Alene, Idaho, United States; Post Falls, Idaho, United States; Sandpoint, Idaho, United States; Bloomington, Illinois, United States; Canton, Illinois, United States; Carthage, Illinois, United States and 48 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.