Prospective Analysis of Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Non-Relapse Mortality (NRM) in Frail, Pre-Frail, and Non-Frail patients
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Cancer-directed Therapy or Best Supportive Care (Other)
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
Intervention: Frailty Assessment (Diagnostic Test)
Transplant
Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy
Intervention: Bone Marrow or Peripheral Blood Graft (BMT) (Procedure)
Transplant
Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy
Intervention: Frailty Assessment (Diagnostic Test)
Outcomes
Primary Outcomes
Non-Relapse Mortality (NRM) in Frail, Pre-Frail, and Non-Frail patients
Time Frame: 1-month
NRM will be defined as death without evidence of disease progression or relapse.
Secondary Outcomes
- NRM by Intensity of Treatment(1-month and 6-month)