NCT03680677 · Abramson Cancer Center at Penn Medicine
Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2025 · Source of record for eligibility and locations