About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 60 years or older.
New diagnosis of Acute Leukemia or MDS, or suspected diagnosis.
Able to consent to the study.
Age 60 years or older with a hematologic malignancy.
Disqualifiers
None
Trial population
Two cohorts of patients will be included in this analysis. Arm A will include patients 60 years of age and older with a new diagnosis of either acute leukemia or MDS who are being evaluated either in the outpatient or inpatient hematologic malignancies department at the University of Pennsylvania. Arm B will include patients 60 years of age and older with a diagnosis of any hematologic malignancy being treated with cellular therapy including allogeneic blood or marrow transplantation or CAR T-cells.
Trial design
Cohort
Prospective
Treatments tested in this trial
Bone Marrow or Peripheral Blood Graft (BMT)
Procedure/SurgeryPatient receives bone marrow or peripheral blood graft (BMT) on or off protocol.
Cancer-directed Therapy or Best Supportive Care
Other interventionCancer-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.
Frailty Assessment
Diagnostic testFrailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
NRM by Intensity of Treatment
NRM of frail and pre-frail patients by intensity of treatment
Sponsors and contacts
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