At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of AML by WHO criteria or high-risk MDS with ≥10% blasts
- ✓Patients older than 65 deemed fit for intensive chemotherapy
- ✓ECOG performance status ≤2
- ✓Creatinine clearance ≥30 mL/min
- ✕t(15;17) karyotype or acute promyelocytic leukemia (FAB M3-AML)
- ✕Prior BCL2 inhibitor therapy
- ✕Known active CNS involvement with AML
- ✕NYHA class III or IV heart failure or LVEF <40%
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b/2 Study of the BCL-2 Inhibitor Venetoclax in Combination With Standard Intensive AML Induction/Consolidation Therapy With FLAG-IDA in Patients With Newly Diagnosed or Relapsed/Refractory AML
In Brief
A Phase 2 clinical trial evaluating Cytarabine, Filgrastim, and 4 other interventions for High Risk Myelodysplastic Syndrome and 2 related conditions. Currently recruiting, targeting 116 participants across 1 site.
Detailed Summary
This phase Ib/II trial studies the best dose and side effects of venetoclax and how well it works when given with combination chemotherapy in treating patients with newly diagnosed acute myeloid leukemia or acute myeloid leukemia that has come back or does not respond to treatment. Venetoclax may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine, cytarabine, filgrastim and idarubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with combination chemotherapy may work better in treating patients with acute myeloid leukemia.
Study Details
Timeline
Interventions
Given IV
Given SC
Given IV
Given IV
Given SC
Given PO