Trial comparing treatments for Acute Myeloid Leukemia
Official title Comparing New Treatments for People With Newly Diagnosed Acute Myeloid Leukemia That Has an IDH2 Gene Change (A MyeloMATCH Treatment Trial)
ClinicalTrials.gov ID: NCT06672146
What this study is testing
What is Decitabine and Cedazuridine (ASTX727)?
An investigational oral medicine being studied as a potential treatment for acute myeloid leukemia. It is designed to block cytidine deaminase (cedazuridine) to keep decitabine active longer, and decitabine works as a hypomethylating agent to help normal blood cell production and kill abnormal cells.
Also referred to as ASTX 727, ASTX-727, ASTX727, C-DEC, CDA Inhibitor E7727/Decitabine Combination Agent, Cedazuridine/Decitabine Tablet, DEC-C, Inaqovi, Inqovi.
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 whether adding enasidenib to the standard ASTX727 and venetoclax regimen improves the chance of clearing the leukemia in patients with the IDH2 gene change.
- Who it's for
- Older adults with newly diagnosed acute myeloid leukemia, or younger adults who cannot tolerate standard therapy, who have an IDH2 mutation.
- What's involved
- Participants receive the oral drug venetoclax and the fixed‑dose combo ASTX727 (cedazuridine and decitabine), with some also taking enasidenib. They will have regular clinic visits for medication administration, blood work, and other safety tests.
- Time commitment
- Treatment lasts several months and requires frequent visits to the clinic for dosing and monitoring.
- 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 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...
- 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...
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 with an AML defining genetic abnormality as described by the...
- 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/m\^2 are permitted to control the WBC prior to enrollment and initiation of...
- Participants must be ≥ 60 years old; OR must be ≥ 18 years old and considered not eligible for cytarabine-based induction therapy
- Participants must have Zubrod Performance Status of 0-3 as determined by a history and physical (H\&P) exam completed within 14 days prior to registration
- Participants must have a complete medical history and physical exam within 14 days prior to registration
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) unless history of Gilbert's syndrome.
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) ≤ 3 × institutional ULN, unless considered to be elevated due...
- Participants must have adequate kidney function as evidenced by creatinine clearance ≥ 30mL/min (by Cockcroft Gault) within 14 days prior to registration
- Participants must not have a baseline corrected QT interval ≥ 480 msec using Fridericia correction (QTcF).
- NOTE: Since older participants are at risk for prolonged QTc and may require supportive care with agents that affect QTc, an electrocardiogram (ECG) is recommended if clinically indicated.
- Participants must have adequate cardiac function in the assessment of their treating physician. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents...
- Participants with known 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 obtained within 6...
- 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 with central nervous system (CNS) involvement are eligible if follow-up CNS evaluation shows no evidence of progression, or if the treating physician determines that immediate CNS specific treatment is not...
- Participants must have agreed to have specimens submitted for translational medicine for MRD under MYELOMATCH and specimens must be submitted
- 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 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Tucson, Arizona, United States
- Little Rock, Arkansas, United States
- San Francisco, California, United States
- Miami, Florida, United States
- Pembroke Pines, Florida, United States
- Augusta, Georgia, United States
- Boise, Idaho, United States
- Coeur d'Alene, Idaho, United States
- Fruitland, Idaho, United States
- Meridian, Idaho, United States
- Nampa, Idaho, United States
- Post Falls, Idaho, United States
- Sandpoint, Idaho, United States
- Chicago, Illinois, United States
- DeKalb, Illinois, United States
- Evanston, Illinois, United States
- Geneva, Illinois, United States
- Glenview, Illinois, United States
- Grayslake, Illinois, United States
- Highland Park, Illinois, United States
+ 89 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Tucson, Arizona, United States; Little Rock, Arkansas, United States; San Francisco, California, United States; Miami, Florida, United States; Pembroke Pines, Florida, United States; Augusta, Georgia, United States and 103 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.