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Chemotherapy-related Cognitive Impairment and Acute Leukemia

UNC Lineberger Comprehensive Cancer Center logo

UNC Lineberger Comprehensive Cancer Center

Status

Completed

Conditions

Acute Myeloid Leukemia

Treatments

Other: none (observational study)

Study type

Observational

Funder types

Other

Identifiers

NCT04644419
LCCC2045

Details and patient eligibility

About

This is an ancillary study of an intervention study (NCT04570709). The parent study is a single institution, feasibility trial of 20 (10 control and 10 intervention) patients with the primary objective of assessing feasibility, acceptability, and change in pre and post measures of symptoms, function, and quality of life by administering the Palliative and Collaborative Care InTervention (PACT). We will further assess cognitive function in the patients who participate in the control of the parent study.

Full description

The study objective is to observe patient-reported and researcher-assessed cognitive function in adults with acute myeloid leukemia with chemotherapy treatment. We will assess cognitive function using a battery of neuropsychological assessments, patient-reported questionnaire, and semi-structured interviews among participants in control group only. The group assignment will be conducted through parent study (NCT04570709). Participating in this study will not affect participants' group assignment.

Enrollment

25 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

[Patient]

Inclusion Criteria:

  • ≥ 60 years of age
  • diagnosis of AML
  • Receive 1) low-dose cytarabine or hypomethylating agent (HMA) in combination with Venetoclax chemotherapy OR 2) low-dose cytarabine or hypomethylating agent (HMA) in combination with Venetoclax chemotherapy and any investigational drugs
  • have caregiver(s) willing to participate
  • participate in the parent study (PACT study, NCT04570709)

Exclusion Criteria:

  • referred to hospice care

[Caregiver]

Inclusion criteria:

  • identified by patient as a caregiver
  • ≥18 years of age
  • speak and read English

Trial design

25 participants in 1 patient group

Control group of the LCCC1848
Description:
Patients in the control arm will receive standard of care.
Treatment:
Other: none (observational study)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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