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

MDS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03680677
• Other study ID #: UPCC 06718
• Secondary ID: 831340
• Status: Recruiting
• Start date: September 21, 2018
• Est. completion date: November 2025

Study information

• Verified date: February 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Shannon McCurdy, MD
• Phone: 855-216-0098
• Email: penncancertrials[@]emergingmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2025
• Est. primary completion date: June 22, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Frailty
• Hematologic Neoplasms
• Leukemia, Acute
• MDS

Intervention

Procedure:
• Bone Marrow or Peripheral Blood Graft (BMT)
Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol.

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.

Locations

Country	Name	City	State
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NRM by Intensity of Treatment	NRM of frail and pre-frail patients by intensity of treatment	1-month and 6-month