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Trial record 25 of 25 for:    ASP 2215 OR Gilteritinib

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

Tracking Information
First Submitted Date September 20, 2018
First Posted Date September 21, 2018
Last Update Posted Date May 30, 2019
Actual Study Start Date September 21, 2018
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 20, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03680677 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 20, 2018)
NRM by Intensity of Treatment [ Time Frame: 1-month and 6-month ]
NRM of frail and pre-frail patients by intensity of treatment
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
Official Title Prospective Analysis of Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.

Condition
  • Leukemia, Acute
  • MDS
Intervention
  • 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.
Study Groups/Cohorts
  • 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
    Interventions:
    • Other: Cancer-directed Therapy or Best Supportive Care
    • Diagnostic Test: Frailty Assessment
  • Transplant
    Bone marrow or peripheral blood graft (BMT) or CAR T-cell therapy
    Interventions:
    • Procedure: Bone Marrow or Peripheral Blood Graft (BMT)
    • Diagnostic Test: Frailty Assessment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 20, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2025
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shannon McCurdy, MD 855-216-0098 penncancertrials@emergingmed.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03680677
Other Study ID Numbers UPCC 06718
831340 ( Other Identifier: U Penn IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Abramson Cancer Center of the University of Pennsylvania
Study Sponsor Abramson Cancer Center of the University of Pennsylvania
Collaborators Not Provided
Investigators
Principal Investigator: Shannon McCurdy, MD Abramson Cancer Center
PRS Account Abramson Cancer Center of the University of Pennsylvania
Verification Date May 2019