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| ID | Type | Description | Link |
|---|---|---|---|
| 831340 | Other Identifier | U Penn IRB |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Transplant | Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone Marrow or Peripheral Blood Graft (BMT) | Procedure | Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol. |
|
| 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 |
| 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 |
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Eligibility Criteria Arm A:
Eligibility Criteria Arm B:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shannon McCurdy, MD | Contact | 855-216-0098 | penncancertrials@emergingmed.com |
| Name | Affiliation | Role |
|---|---|---|
| Shannon McCurdy, MD | Abramson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abramson Cancer Center of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Cancer-directed Therapy or Best Supportive Care | Other | 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. |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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