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Recruiting NCT03680677

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

— Observational Leukemia, Acute MDS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bone Marrow or Peripheral Blood Graft (BMT), Cancer-directed Therapy or Best Supportive Care, Frailty Assessment.
Who it may be relevant to
Registry conditions: Leukemia, Acute, MDS. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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]
Secondary outcome measures (1)
  • NRM by Intensity of Treatment [Time frame: 1-month and 6-month]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Abramson Cancer Center of the University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT03680677 · UPCC 06718 · 831340

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗