Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies

Prospective Analysis of Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03680677

Enrollment

Registered

2018-09-21

Start date

2018-09-21

Completion date

2026-11-30

Last updated

2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Acute, MDS

Brief summary

The purpose of this research study is to determine if frailty assessments can be used to predict how well patients aged 60 years and older will do after chemotherapy, CAR T-cell therapy, or allogeneic stem cell transplant.

Interventions

PROCEDUREBone Marrow or Peripheral Blood Graft (BMT)

Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol.

OTHERCancer-directed Therapy or Best Supportive Care

Cancer-directed therapy with intensive regimens (7+3, Vyxeos, clofarabine, or similar), clinical trial, hypomethylating agent (azacitidine or decitabine), hypomethylating agent combinations (i.e. with venetoclax, sorafenib, enasidenib, ivosidenib, midostaurin, gilteritinib, or other targeted agent), targeted agents alone (i.e. enasidenib, ivosidenib, gilteritinib, midostaurin, etc.), or supportive care.

DIAGNOSTIC_TESTFrailty Assessment

Frailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

Eligibility Criteria Arm A: * Age 60 years or older. * New diagnosis of Acute Leukemia or MDS, or suspected diagnosis. * Able to consent to the study. Eligibility Criteria Arm B: * Age 60 years or older with a hematologic malignancy. * Plan to undergo an allogeneic blood or marrow transplantation or CAR T-cell therapy. * Able to consent to the study.

Design outcomes

Primary

Measure	Time frame	Description
Non-Relapse Mortality (NRM) in Frail, Pre-Frail, and Non-Frail patients	1-month	NRM will be defined as death without evidence of disease progression or relapse.

Secondary

Measure	Time frame	Description
NRM by Intensity of Treatment	1-month and 6-month	NRM of frail and pre-frail patients by intensity of treatment

Countries

United States

Contacts

Primary ContactShannon McCurdy, MD

penncancertrials@emergingmed.com855-216-0098

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026