Geriatric Assessment & Genetic Profiling to Personalize Therapy in Older Adults With Acute Myeloid Leukemia

Summary

Acute myeloid leukemia (AML) is among the most common hematologic malignancies in adults and accounts for approximately 10,000 deaths in the United States every year. AML is commonly diagnosed in sixth or seventh decades of life. The management of AML is complex in older patients because of associated comorbidities, intolerance to high-dose chemotherapy and high-risk tumor biology. In real world practice, over one-third of patients aged 60 years and older do not receive initial chemotherapy for AML, consequently, only 10-20% of patients are alive at 3-5 years. Longer-term survival has not improved significantly in last few decades. Poor survival of older patients with AML may be improved with refined risk-stratification and therapy selection strategies, integration of principles of geriatric medicine, and use of effective but low intensity and novel therapies.

This study will examine the impact of clinicogenetic risk-stratified management on outcomes of acute myeloid leukemia in older participants (≥ 60 years) with newly diagnosed acute myeloid leukemia who receive clinicogenetic risk-stratified therapy allocation. Participants will receive standard of care intensive or low-intensity induction based on cytogenetic and geriatric assessment-based risk stratification. Participants will be evaluated for disease status, survival, quality of life and neurocognitive status for 90 days and then followed for a total of 2 years for survival data.

Conditions

• Adult Acute Myeloid Leukemia
• Secondary Acute Myeloid Leukemia
• Therapy-Related Acute Myeloid Leukemia

Interventions

DRUG

Cytarabine

Given IV

DRUG

Decitabine

Given IV

DRUG

Idarubicin

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Liposome-encapsulated Daunorubicin-Cytarabine

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Azacitidine

Given by infusion

DRUG

Venetoclax

oral tablet

DRUG

glasdegib

oral tablet

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Nebraska

  lead OTHER

Principal Investigators

• Vijaya R Bhatt, MD · University of Nebraska

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-07

Primary Completion

2024-03-16

Completion

2024-10-01

FDA Drug

Yes

Countries

• United States

Study Locations