Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Cancer Directed Therapy or Best Supportive Care 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
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 Test: Frailty Assessment
Frailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors.
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Transplant Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy |
Procedure: Bone Marrow or Peripheral Blood Graft (BMT)
Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol.
Diagnostic Test: Frailty Assessment
Frailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors.
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Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- NRM by Intensity of Treatment [1-month and 6-month]
NRM of frail and pre-frail patients by intensity of treatment
Eligibility Criteria
Criteria
Eligibility Criteria Arm A:
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Age 60 years or older.
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New diagnosis of Acute Leukemia or MDS, or suspected diagnosis.
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Able to consent to the study.
Eligibility Criteria Arm B:
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Age 60 years or older with a hematologic malignancy.
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Plan to undergo an allogeneic blood or marrow transplantation or CAR T-cell therapy.
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Able to consent to the study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
Investigators
- Principal Investigator: Shannon McCurdy, MD, Abramson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UPCC 06718
- 831340