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

Sponsor
Abramson Cancer Center of the University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT03680677
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bone Marrow or Peripheral Blood Graft (BMT)
  • Other: Cancer-directed Therapy or Best Supportive Care
  • Diagnostic Test: Frailty Assessment

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Analysis of Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
Actual Study Start Date :
Sep 21, 2018
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

Arm Intervention/Treatment
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

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.

Transplant

Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy

Procedure: Bone Marrow or Peripheral Blood Graft (BMT)
Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol.

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

Outcome Measures

Primary Outcome Measures

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

    NRM will be defined as death without evidence of disease progression or relapse.

Secondary Outcome Measures

  1. NRM by Intensity of Treatment [1-month and 6-month]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • Abramson Cancer Center of the University of Pennsylvania

Investigators

  • Principal Investigator: Shannon McCurdy, MD, Abramson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT03680677
Other Study ID Numbers:
  • UPCC 06718
  • 831340
First Posted:
Sep 21, 2018
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 11, 2022