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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT03680677
Status
Recruiting
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Conditions

  • Leukemia, Acute
  • MDS

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Sep 21, 2018
Status verified
Jul 2025
Primary completion
Jun 22, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
20 participants (estimated)

Arms

  • Arm: 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
  • Arm: Transplant
    Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy

Primary Outcome Measure

Non-Relapse Mortality (NRM) in Frail, Pre-Frail, and Non-Frail patients [ Time Frame: 1-month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
Abramson Cancer Center of the University of Pennsylvania· Philadelphia, PA

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