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

Study Overview
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Brief Summary
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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.

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

Conditions
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MDS, Leukemia, Acute

Intervention / Treatment
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* Procedure: Bone Marrow or Peripheral Blood Graft (BMT)
* Other: Cancer-directed Therapy or Best Supportive Care
* Diagnostic Test: Frailty Assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer Directed Therapy or Best Supportive Care<br>Cancer-directed therapy with intensive regimens, clinical trial, hypomethylating agent, hypomethylating agent combinations, targeted agents alone, or best supportive care | Other: Cancer-directed Therapy or Best Supportive Care<br>* 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.<br>Diagnostic Test: Frailty Assessment<br>* Frailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors.<br>|
| Transplant<br>Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy | Procedure: Bone Marrow or Peripheral Blood Graft (BMT)<br>* Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol.<br>Diagnostic Test: Frailty Assessment<br>* Frailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1-month | 

Secondary Outcome Measures

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