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

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ClinicalTrials.gov Identifier: NCT03680677
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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
Leukemia, Acute MDS Procedure: Bone Marrow or Peripheral Blood Graft (BMT) Other: Cancer-directed Therapy or Best Supportive Care Diagnostic Test: Frailty Assessment

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Study Type : Observational
Estimated 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 : September 21, 2018
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort 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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. NRM by Intensity of Treatment [ Time Frame: 1-month and 6-month ]
    NRM of frail and pre-frail patients by intensity of treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Two cohorts of patients will be included in this analysis.

Arm A will include patients 60 years of age and older with a new diagnosis of either acute leukemia or MDS who are being evaluated either in the outpatient or inpatient hematologic malignancies department at the University of Pennsylvania.

Arm B will include patients 60 years of age and older with a diagnosis of any hematologic malignancy being treated with cellular therapy including allogeneic blood or marrow transplantation or CAR T-cells.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03680677


Contacts
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Contact: Shannon McCurdy, MD 855-216-0098 penncancertrials@emergingmed.com

Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Shannon McCurdy, MD Abramson Cancer Center

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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03680677     History of Changes
Other Study ID Numbers: UPCC 06718
831340 ( Other Identifier: U Penn IRB )
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Frailty
Pathologic Processes