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Not yet recruitingPhase 2

Phase II De-Escalation Study of Metronomic Decitabine/Cedazuridine Plus Venetoclax in AML

A Phase II De-Escalation Study of Metronomic Decitabine/Cedazuridine Plus Venetoclax in Acute Myeloid Leukemia Maintenance.

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests weekly decitabine/cedazuridine plus venetoclax to help keep acute myeloid leukemia (AML), a blood cancer, from coming back. It is for adults who cannot have intensive starting chemotherapy and whose AML went into remission after initial treatment. The study checks whether people stay alive without AML returning for 12 months.

To evaluate the 12-month relapse free survival with weekly Decitabine/cedazuridine plus Venetoclax in AML maintenance after achieving composite CR (CR, CRi, CRh)

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have newly diagnosed AML that meets the study’s diagnosis rules.
  • Be unable to have intensive starting chemotherapy: either age 75 or older, or age 18–74 with one of the health problems listed below.
  • If age 18–74, have severe heart or lung disease, reduced kidney function, or moderate liver problems that meet the study’s test limits.
  • Have reached remission after no more than 3 rounds of standard IV hypomethylating drugs (HMAs) plus venetoclax. Remission means signs of leukemia are gone, though blood counts may not have fully recovered.
  • Be able to understand the study and agree to take part.
  • Have an ECOG activity score of 0–3, ranging from fully active to needing some help with self-care and spending much of the day in bed or a chair.
  • Past or current use of hydroxyurea is allowed.

Who can't join

  • AML got worse or came back after starting treatment with standard HMAs plus venetoclax.
  • Are pregnant or breastfeeding.
  • Have an infection that is not under control.
  • Have active disease in the brain or spinal cord.
  • Have another cancer that needs treatment that works throughout the body.
  • Cannot take medicine by mouth, have trouble absorbing nutrients, or have another digestive condition that is not under control.
  • Can receive intensive chemotherapy.
  • Can receive a stem cell transplant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Newly diagnosed AML (WHO 2022 classification or ICC 2022 classification) * Participants must be considered Ineligible for intensive induction defined by the following: 1. Age 75 years or older, or 2. Age 18 to 74 years with at least one of the following comorbidities: i) Severe cardiac disorder (eg, congestive heart failure requiring treatment, ejection fraction ≤50%, or chronic stable angina). ii) Severe pulmonary disorder (eg, DLCO ≤65% or FEV1 ≤65%). iii) Creatinine clearance ≥30 mL/min to \<45 mL/min iv) Moderate hepatic impairment with total bilirubin \>1.5 to ≤3.0 × upper limit of normal (ULN). * Must have achieved CR,CRh, CRi, following induction with maximum 3 cycles of standard IV HMAs and venetoclax. * Able to provide informed consent * Prior and concomitant hydroxyurea is permitted * ECOG performance status 0 to 3 Exclusion Criteria: * Progression or relapse after induction standard HMAs + Venetoclax therapy * Pregnancy or breastfeeding * Uncontrolled infection, active CNS disease, or concurrent malignancy requiring systemic therapy * Inability to take oral medication or presence of malabsorption syndrome or any other uncontrolled gastrointestinal condition * Candidate for intensive chemotherapy * Uncontrolled infection, active CNS disease, or concurrent malignancy requiring systemic therapy * Candidate for stem cell transplant

Study sites (1)

NJ