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NCT Number: NCT03680677

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.

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Key information

Conditions

Leukemia, Acute Hematologic Diseases Hemic and Lymphatic Diseases Leukemia MDS Neoplasms Neoplasms by Histologic Type

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bone Marrow or Peripheral Blood Graft (BMT)

Procedure

Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol.

Cancer-directed Therapy or Best Supportive Care

Other

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.

Frailty Assessment

Diagnostic Test

Frailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors.

Primary outcomes

  1. 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

  1. NRM by Intensity of Treatment

    Time frame: 1-month and 6-month

    NRM of frail and pre-frail patients by intensity of treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Shannon McCurdy, MD

CONTACT

[email protected]

855-216-0098

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2018
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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