Discontinuation of Hypomethylating Agent and Venetoclax in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) Who Have Achieved Negative Measurable Residual Disease (MRD)
Summary
The purpose of this research study is to see if people whose Acute myeloid leukemia (AML) is being successfully treated with azacitidine or decitabine in combination with venetoclax can discontinue this chemotherapy for some period of time after a year of treatment without increasing the likelihood that their AML will return.
Arms & interventions
- DrugAzacitidine
Standard of Care Intravenous (IV) infusion
- DrugDecitabine
Standard of Care Intravenous (IV) infusion
- DrugVenetoclax
Standard of Care PO (By Mouth)
Outcome measures
Primary
Rates of Complete Response (CR)/Complete Response with incomplete hematologic recovery (CRi)
Rates of CR/CRi at 18 months from the time of initial CR/CRi in patients who discontinue frontline HMA (azacitidine or decitabine)/VEN (venetoclax) after achieving Measurable Residual Disease (MRD) negativity by MFC within 12 months of starting therapy. The Null hypothesis (p0) will be tested against the alternative hypothesis (p1). Null hypothesis: p0 ≤ 50% will remain in CR/CRi at 18 months from the time of initial CR/CRi Alternative hypothesis: p1 ≥ 70% will remain in CR/CRi at 18 months from the time of initial CR/CRi
Time frame: Up to 18 Months
Secondary
Overall Survival (OS)
Time frame: Up to 36 Months
Rates to Re-Treatment
Time frame: Up to 36 Months
Treatment Free Molecular Remission (TFMR)
Time frame: Up to 36 Months
European Organization for Research and Treatment of Cancer (EORTC-QLQ-C30)/Quality of Life (QoL)
Time frame: Day 1 (start of enrollment), start of Discontinuation Phase, and monthly until EOT (Up to 36 Months)
Patient Reported Outcome Measurement Information System (PROMIS)
Time frame: Day 1 (start of enrollment), start of Discontinuation Phase, and monthly until EOT (Up to 36 Months)
EuroQoL-5 Dimensions-5 Levels (EQ-5D-5L) Visual Analog Scale (VAS)
Time frame: Day 1 (start of enrollment), start of Discontinuation Phase, and monthly until EOT (Up to 36 Months)
Eligibility criteria
Study locations (1)
Moffitt Cancer Center
Tampa, Florida, 33612