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

Secondary Acute Myeloid Leukemia Clinical Trial

Official title: A Phase II Study of the Impact of Clinicogenetic Risk-Stratified Management on Outcomes of Acute Myeloid Leukemia in Older Patients

Status Active, not recruiting

Clinical Trial Summary

This phase II trial of the impact of clinicogenetic risk-stratified management on outcomes of acute myeloid leukemia in older patients is 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, who receive clinicogenetic risk-stratified therapy allocation.

Subjects will receive standard of care intensive or low-intensity induction based on cytogenetic and geriatric assessment-based risk stratification.

Subjects 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.

Clinical Trial Description

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.

OUTLINE: Patients are assigned to 1 or 2 groups based on cytogenetic and geriatric assessment-based risk stratification.

GROUP I:

INTENSIVE INDUCTION THERAPY: Patients receive cytarabine intravenously (IV) on days 1-7 and idarubicin over 10-15 minutes on days 1-3 (7+3), or liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1, 3 and 5. Gemtuzumab or midostaurin are added to 7+3 as per the standard of care. Treatment continues for 1 course in the absence of disease progression or unacceptable toxicity.

INTENSIVE CONSOLIDATION THERAPY: Patients who go into remission, receive cytarabine IV over 1-3 hours twice daily (BID) on days 1, 3, and 5. Treatment repeats every 4 weeks for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients treated with liposome-encapsulated daunorubicin-cytarabine receive liposome-encapsulated daunorubicin-cytarabine IV over 90 minutes on days 1 and 3. Treatment repeats every 5-8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity.

GROUP II:

LOW-INTENSITY INDUCTION: Patients receive oral venetoclax and azacitidine IV on days 1-7 or decitabine IV on days 1-5. Alternate standard of care low-intensity therapies are allowed at the discretion of treating physician. Treatment repeats every 4 weeks for 1-4 courses in the absence of disease progression or unacceptable toxicity.

LOW-INTENSITY CONSOLIDATION: Patients who achieve complete remission, receive oral venetoclax and azacitidine IV on days 1-7 or decitabine IV on days 1-5 or other standard of care low-intensity chemotherapy. Treatment repeats every 4 weeks for 3 or more courses in the absence of disease progression, unacceptable toxicity or receipt of allogeneic stem cell transplant.

After completion of study treatment, patients are followed up for up to 2 years. ;

Related Conditions & MeSH terms

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

• NCT number: NCT03226418
• Study type: Interventional
• Source: University of Nebraska
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 7, 2017
• Completion date: October 7, 2024