Feasibility Pilot Exploring Variability in Biomarkers and PROs in AML

Dana-Farber Cancer Institute

Status: Completed

Conditions: Acute Myeloid Leukemia (AML)

Treatments: Other: Blood Sample Collection - Observational Study; Other: Symptom questionnaires - Observational Study

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04908852

21-161

N98F20P00013 (Other Identifier)

Details and patient eligibility

About

This research study is being conducted to help understand how the symptoms during treatment for acute myeloid leukemia (AML) may be affected by metabolism and how best to study this association. Symptoms include experiences like fatigue, sleep disturbance, pain, and depression.

Full description

This is a prospective, longitudinal, observational exploratory study. Ten participants will be enrolled and will complete baseline and week 4 blood sample collections. Symptom questionnaires will be completed at baseline, 1-, 2-, 3- and 4-weeks.

This research study is a Pilot Study, which means it is the first time that researchers are studying the associations between symptoms and metabolism in this way.

The National Institute of Nursing Research is supporting this research study by providing funding for the research study.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The Cantor Center CRC will attend weekly protocol meetings in the DFCI adult leukemia center to identify eligible patients and will confirm eligibility by reviewing the electronic health record and, if needed, contacting the treating physician. Subjects enrolled in clinical trials or other studies requiring extra blood samples and/or completion of questionnaires will be discussed with their oncology care team and/or investigators of the other study teams to ensure avoidance of excess subject burden. Only subjects deemed appropriate for enrollment without adding excess burden will be approached about this study.

• Inclusion Criteria:

  • Adult (18+ years old)
  • New diagnosis of acute myeloid leukemia (AML)
  • Admitted to the DFCI Inpatient Hospital in the BWH for intensive induction chemotherapy (e.g., 7+3 regimen)
  • Eastern Cooperative Oncology Group Scale of Performance Status (ECOG PS) ≤ 3 OR Karnofsky Performance Status (KPS) ≥ 50
  • Ability to comprehend and speak English
  • Ability to provide informed consent

Exclusion criteria

• Cognitive or psychiatric conditions prohibiting study consent or participation
• Multiple primary cancers
• A treating clinician reports that the subject is inappropriate for the study or that the study presents excess subject burden

Trial design

10 participants in 1 patient group

Cohort 1

Description:

This is a prospective, longitudinal, observational exploratory study. Ten subjects will be enrolled and will complete baseline and week 4 blood draws and symptom questionnaires at baseline, 1-, 2-, 3- and 4-weeks.

Treatment:

Other: Blood Sample Collection - Observational Study

Other: Symptom questionnaires - Observational Study