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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorAbramson Cancer Center at Penn Medicine

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Bone Marrow or Peripheral Blood Graft (BMT)

    Procedure/Surgery

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

  • Cancer-directed Therapy or Best Supportive Care

    Other intervention

    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.

  • Frailty Assessment

    Diagnostic test

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Cancer Directed Therapy or Best Supportive Care2 interventions
Group B: Transplant2 interventions

Trial outcomes

Primary outcomes

1

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 outcomes

1

NRM by Intensity of Treatment

NRM of frail and pre-frail patients by intensity of treatment

Time frame
1-month and 6-month

Other outcomes

Sponsors and contacts

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