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

Recruiting

• Conditions: Leukemia, Acute; MDS
• Interventions: Procedure: Bone Marrow or Peripheral Blood Graft (BMT); Other: Cancer-directed Therapy or Best Supportive Care; Diagnostic Test: Frailty Assessment

• Registration Number: NCT03680677
• Lead Sponsor: Abramson Cancer Center at Penn Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-20
• Study Start: 2018-09-21
• Study First Posted: 2018-09-21
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Primary Completion: 2025-06-22
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transplant	Bone Marrow or Peripheral Blood Graft (BMT)	Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy
Cancer Directed Therapy or Best Supportive Care	Frailty Assessment	Cancer-directed therapy with intensive regimens, clinical trial, hypomethylating agent, hypomethylating agent combinations, targeted agents alone, or best supportive care
Cancer Directed Therapy or Best Supportive Care	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	Frailty Assessment	Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
NRM by Intensity of Treatment	1-month and 6-month	NRM of frail and pre-frail patients by intensity of treatment

Trial Locations

Locations (1)

Abramson Cancer Center of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States