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

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

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.

Study Overview

• Status: Recruiting
• Conditions: MDS; Leukemia, Acute
• Intervention / Treatment: Other: Cancer-directed Therapy or Best Supportive Care; Diagnostic test: Frailty Assessment; Procedure: Bone Marrow or Peripheral Blood Graft (BMT)

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Shannon McCurdy, MD; Phone Number: 855-216-0098; Email: penncancertrials@emergingmed.com

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Abramson Cancer Center of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.
Transplant; Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy	Diagnostic test: Frailty Assessment; Frailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors.; Procedure: Bone Marrow or Peripheral Blood Graft (BMT); Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Investigators: Principal Investigator: Shannon McCurdy, MD, Abramson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2018
• Primary Completion (Estimated): June 22, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms; Frailty
• Other Study ID Numbers: UPCC 06718; 831340 (Other Identifier: U Penn IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No