At a glance
ClinicalIndex Comparison Record- ✓Previously untreated acute myeloid leukemia (AML)
- ✓Age ≥50 years, or <50 years if unsuitable for standard induction therapy after investigator discussion
- ✓Adequate liver function: bilirubin <2mg/dL, AST/ALT <3 x ULN (unless due to leukemic infiltration)
- ✓Adequate kidney function: creatinine <1.5 x ULN
- ✕Pregnant women
- ✕Breastfeeding women
- ✕Uncontrolled intercurrent illness including active infection, symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness limiting compliance
- ✕Documented hypersensitivity to any chemotherapy agent components
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Venetoclax Added to Cladribine Plus Low Dose Cytarabine (LDAC) Induction Followed by Consolidation With Cladribine Plus LDAC Alternating With 5-Azacitidine With Venetoclax in Patients With Untreated AML
In Brief
A Phase 2 clinical trial evaluating Azacitidine, Cladribine, and 2 other interventions for Acute Myeloid Leukemia. Currently recruiting, targeting 145 participants across 1 site.
Detailed Summary
This phase II trial studies how well venetoclax, cladribine, low dose cytarabine, and azacitidine work in treating patients with acute myeloid leukemia that has previously not been treated. Drugs used in chemotherapy, such as venetoclax, cladribine, and low dose cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Azacitidine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving venetoclax, cladribine, low dose cytarabine induction followed by cladribine, low dose cytarabine, and azacitidine consolidation may work better in treating patients with acute myeloid leukemia.
Study Details
Timeline
Arms & Interventions
See Detailed Description.
Interventions
Given SC or IV
Given IV
Given SC
Given PO