An Study of Patients With Ph- Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US

April 24, 2020 updated by: Amgen

An Observational Study of Patients With Philadelphia Chromosome-negative Relapsed or Refractory Acute Lymphoblastic Leukemia in the US

A retrospective chart review study of Philadelphia chromosome-negative R/R ALL patients in the US.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

212

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Research Site
    • California
      • Duarte, California, United States, 91010
        • Research Site
      • Los Angeles, California, United States, 90089
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Research Site
    • Iowa
      • Ames, Iowa, United States, 50010
        • Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Research Site
      • Baltimore, Maryland, United States, 21287
        • Research Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Research Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Research Site
    • New York
      • Buffalo, New York, United States, 14263
        • Research Site
      • New York, New York, United States, 10065
        • Research Site
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Research Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Research Site
      • Cleveland, Ohio, United States, 44106
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
    • Texas
      • Austin, Texas, United States, 78701
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients initiating treatment for Philadelphia chromosome-negative (Ph-) R/R ALL between January 2013 and March 2019 at participating clinical sites in the US

Description

Inclusion Criteria

-Medical records of patients initiating treatment for Ph- R/R ALL at participating clinical centers in the US between January 2013 and March 2019 will be eligible for inclusion.

Exclusion Criteria

  • Medical records of patients with Ph+ ALL will be excluded.
  • If informed consent is required, medical records of patients who do not provide informed consent will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No treatment 1
It is planned to have 20-30 sites participating on the trial for chart review of approximately 200-235 patients initiating treatment for Philadelphia chromosome-negative (Ph-) Relapsed or Refractory (R/R) Acute Lymphoblastic Leukemia (ALL) between January 2013 and March 2019.
Other: Other
No intervention other than routine medical care
No Treatment 2
Initial record abstraction will occur at study site with subsequent reviews occurring at the site every 3 months thereafter until study conclusion on March 2020.
Other: Other
No intervention other than routine medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment patterns in patients with Ph- R/R ALL
Time Frame: 86 months
86 months
Drug utilization in patients with Ph- R/R ALL
Time Frame: 86 months
86 months
Healthcare resource utilization in patients with Ph- R/R ALL
Time Frame: 86 months
86 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Receipt of allogeneic stem cell transplantation following salvage treatment
Time Frame: 86 Months
86 Months
Incidence of selected adverse events including cytokine release syndrome, neurologic events, any events resulting in hospitalizations, and other serious adverse events.
Time Frame: 86 Months
86 Months
Best response to salvage treatment (chemotherapy or blinatumomab) within 8 weeks and within 12 weeks of initiation of salvage treatment.
Time Frame: 12 Weeks
12 Weeks
MRD status within 12 weeks of initiation of salvage treatment
Time Frame: 12 Weeks
12 Weeks
Overall survival from the time of initiation of salvage treatment
Time Frame: 86 Months
86 Months
RFS from time remission achieved with salvage treatment
Time Frame: 86 Months
86 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2016

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

May 11, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 27, 2020

Last Update Submitted That Met QC Criteria

April 24, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

IPD Sharing Time Frame

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD Sharing Access Criteria

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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