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New treatment option for Acute Myeloid Leukemia
Official title Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality
ClinicalTrials.gov ID: NCT06370000
What this study is testing
What is Oral Azacitidine?
Oral Azacitidine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute myeloid leukemia.
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
- Test feasibility of an oral maintenance strategy for transplant eligible AML patients in first CR who are medically underserved or have a disadvantage in the CDC SDOH domains
- Phase 4: studies an already-approved treatment
- 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
- Patients must have histologically or cytologically confirmed non-Acute Promyelocytic (APL) FLT3 negative AML and have completed induction and...
- For patients in CR1, AML disease phenotype must be one that is considered for allo HCT in CR1 (intermediate or high risk by European Leukemia Net...
- Medically eligible for allogeneic hematopoietic cell transplant (allo HCT) as defined by either: treating physician discretion, transplant physician...
- Age ≥ 18 years
- Enrollment must occur within 4 months of completion of therapy
You likely can't join if
- A patient who meets any of the following exclusion criteria is ineligible to participate in the study.
- FMS-like tyrosine kinase 3 (FLT3 ITD) or tyrosine kinase domain (TKD) mutation
- Uncontrolled central nervous system (CNS) involvement
- History of hypersensitivity or allergic reaction to azacitidine or its components
- Stem cell transplant within previous 3 months prior to initiation of study therapy
- Uncontrolled intercurrent illness or infection
See the full eligibility criteria
- Patients must have histologically or cytologically confirmed non-Acute Promyelocytic (APL) FLT3 negative AML and have completed induction and consolidation as defined by the treating physician and must be in complete...
- For patients in CR1, AML disease phenotype must be one that is considered for allo HCT in CR1 (intermediate or high risk by European Leukemia Net (ELN), MRD+ CR, slow clearance of MRD) or any AML phenotype (aside from...
- Medically eligible for allogeneic hematopoietic cell transplant (allo HCT) as defined by either: treating physician discretion, transplant physician discretion, or hematopoietic cell transplantation-specific Comorbidity...
- Age ≥ 18 years
- Enrollment must occur within 4 months of completion of therapy
- A patient or staff identified health disparity in 1 of the 5 Centers for Disease Control (CDC) defined social determinants of health (SDOH). This may include financial difficulties, lack of caregiver support...
- Patient must have adequate organ function defined as: Creatinine clearance (by Cockroft-Gault formula) greater than or equal to 29 mL/min, total bilirubin and aspartate aminotransferase/ alanine transaminase (AST/ALT) ≤...
- Eastern Cooperative Oncology Group (ECOG) 0,1,2,3
- Ability to take oral medications
- No history of malabsorption syndrome which, in the investigator's opinion, may inhibit absorption of oral medications
- Women of childbearing potential must consent to effective contraception during study treatment and at least 6 months following the last dose. Women who are breastfeeding are also excluded
- Male patients must consent to effective contraception during study and at least 3 months after last dose
- Ability to understand and the willingness to sign a written informed consent document
- A patient who meets any of the following exclusion criteria is ineligible to participate in the study.
- FMS-like tyrosine kinase 3 (FLT3 ITD) or tyrosine kinase domain (TKD) mutation
- Uncontrolled central nervous system (CNS) involvement
- History of hypersensitivity or allergic reaction to azacitidine or its components
- Stem cell transplant within previous 3 months prior to initiation of study therapy
- Uncontrolled intercurrent illness or infection
- History of prior therapy with oral azacitidine
- Female patients who are pregnant or intend to donate eggs during the study or for 6 months after receiving their last dose of study drug
- Male patients who intend to donate sperm during the course of this study or for 3 months after last dose
- Other malignancy for which the patient is currently receiving therapy (except excisable skin cancer)
- Medical, psychological, or social condition that, in the opinion of the investigator, may increase the participant's risk or limit the participant's adherence with study requirements
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, 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 Richmond, Virginia, 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.