RecruitingObservational

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

NCT ID: NCT03680677Sponsor: Abramson Cancer Center at Penn MedicineLast updated: 2025-07-31

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.

Arms & 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.

Outcome measures

Primary

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

Secondary

NRM by Intensity of Treatment
Time frame: 1-month and 6-month

Eligibility criteria

Sex: AllAge: 60 Years and olderHealthy volunteers: No

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.

Study locations (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting