A phase II study of the impact of clinicogenetic risk-stratefied management on outcomes of acute myeloid leukemia in older patients
Categories (click each to see list of all clinical trials associated with that category): Leukemia/Myelodysplastic syndromes (MDS)/Myeloproliferative disorders (MPD)
Current Status: Open to accrual
Phase: II
Principal Investigator: Bhatt, Vijaya
Eligibility: https://clinicaltrials.gov/ct2/show/NCT03226418#eligibility
Summary
PRIMARY OBJECTIVES:
I. To determine the rate of complete remission and mortality at 90 days in the entire cohort of older patients (>= 60 years) with newly diagnosed acute myeloid leukemia (AML) who receive clinicogenetic risk-stratified therapy allocation.
SECONDARY OBJECTIVES:
I. To determine the rate of complete remission and mortality at 90 days in subsets of older patients who receive intensive and low-intensity chemotherapy.
II. To assess the impact of baseline functional status (measured by geriatric assessment) on the rate of complete remission and mortality at 90 days in older patients, who receive clinicogenetic risk-stratified therapy allocation.
III. To evaluate the influence of baseline functional status on the quality of life, grades 3 and 4 toxicities (Common Terminology Criteria for Adverse Events [CTCAE] version 4.03 grades) and neurocognitive status at baseline and at 90 days in older patients.
IV. To determine the symptom burden at diagnosis and 10, 30 and 90 days following initiation of chemotherapy.
V. To determine proportion of patients with impairments detected by geriatric assessment.