DNA Hypomethylating Agents and Lenalidomide in Elderly Patients With Myeloid Malignancies in the US

Acute Myeloid Leukemia Clinical Trial

Official title: Effectiveness of DNA Hypomethylating Agents and Lenalidomide in Elderly Patients With Myeloid Malignancies in the United States

Status Withdrawn

Clinical Trial Summary

The study aims to comprehensively analyze data from a large and unselected older AML population in the US, both treated and untreated. These data will widen understanding of treatment decisions for the older Acute Myeloid Leukemia (AML) population. Through use of the SEER-Medicare Registry, the effectiveness and impact of HMA treatments as well as the effectiveness of lenalidomide will be studied.

Clinical Trial Description

This will be the first study to comprehensively analyze data from a large and unselected older AML population in the US, both treated and untreated. These data will widen understanding of treatment decisions for the older AML population and shed light on the impact of HMA in this vulnerable population. The findings from this study will help identify the role of HMA (with its salient features of better tolerability and lesser toxicity) as a new treatment paradigm for older AML patients and enable comparison of outcomes with HMA vs other "conventional" leukemia therapies (intensive chemotherapy, low dose cytarabine or best supportive care). Additionally, with updated SEER-Medicare file carrying Medicare claims through 2013, this study will help analyze several long term outcome measures extending up to eight years for MDS patients treated with lenalidomide. Finally, the effectiveness of HMA in the SEER-Medicare MDS population will be studied by using SEER-Medicare data. This registry includes information on Medicare MDS beneficiaries - a population age cohort that has the highest incidence rates for MDS and a large sample size with absolute MDS cases approaching 40000, making it the largest MDS registry in the world.

The overall sample will include cases of MDS and AML newly diagnosed between 2001 and 2011 with claims from 2000 to 2012. Investigators estimate this will include approximately 50,000 patients.Therefore, the Target Follow Up design looks at patient records over a span of 12 years. Consists of patients with myeloid malignancies diagnosed during 2001-2011 at the age of 66 years or older and alive in September 2004 (i.e. 3 months after FDA approval of azacitidine for MDS), with known month of diagnosis, and not identified from death certificates or autopsy only, who had continuous Medicare Part A and B coverage, and were not enrolled in a health maintenance organization during the period of interest. The overall sample will include cases of MDS and AML newly diagnosed between 2001 and 2011 with claims from 2000 to 2012.

Variables of interest to be collected will include: MDS subtypes, age at diagnosis, sex, race, comorbidities, median household income at the zip code level, treatments (including supportive care) from diagnosis to AML progression, transfusion status, NCI comorbidity index score, response to treatments (using International Working Group criteria), physician characteristics (speciality data),and hospital characteristics (bed size, teaching status, case volume). ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes

• NCT number: NCT02863458
• Study type: Observational [Patient Registry]
• Source: The Cleveland Clinic
• Status: Withdrawn
• Start date: September 1, 2018
• Completion date: September 30, 2020