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

NCT ID: NCT02783651

Last Updated: 2020-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

212 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-03-31

Brief Summary

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

Detailed Description

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Conditions

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Relapsed/Refractory Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Intervention Type 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

Intervention Type OTHER

No intervention other than routine medical care

Interventions

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Other

No intervention other than routine medical care

Intervention Type OTHER

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Amgen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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Research Site

Tucson, Arizona, United States

Site Status

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Duarte, California, United States

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Los Angeles, California, United States

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Chicago, Illinois, United States

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Ames, Iowa, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Detroit, Michigan, United States

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Hackensack, New Jersey, United States

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Buffalo, New York, United States

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New York, New York, United States

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Winston-Salem, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Austin, Texas, United States

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Seattle, Washington, United States

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Countries

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United States

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20150253

Identifier Type: -

Identifier Source: org_study_id

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