Historical Data Analysis of Complete Remission in Children With R/R Acute Lymphoblastic Leukemia (ALL)

NCT ID: NCT02303522

Last Updated: 2020-05-06

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

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-09

Study Completion Date

2015-01-22

Brief Summary

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An historical data comparator study for children with relapsed/refactory acute lymphoblastic leukemia (ALL).

Detailed Description

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A retrospective observational study reviewing historical complete remission for pediatric patients who had either relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL)

Conditions

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B-cell Precursor Acute Lymphoblastic Leukemia (ALL)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All subjects

All subjects will be included in a unique cohort

Other: not applicable - observational study

Intervention Type OTHER

No intervention exists as this is a retrospective observational study

Interventions

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Other: not applicable - observational study

No intervention exists as this is a retrospective observational study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pediatric (age less than 18 years) patients with relapsed or refractory B-cell precursor ALL, specifically those with
* 2nd or later relapse after chemotherapy (with no prior transplantation),
* Relapse after HSCT, or
* Refractory disease
* Had treatment for relapsed or refractory disease between 2005-2012
* Has data available on ALL treatment, including number of salvage treatments, response status after therapies, and HSCT

Exclusion Criteria

* No CNS involvement at relapse
* No previous treatment with blinatumomab
Maximum Eligible Age

17 Years

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

Vienna, , Austria

Site Status

Research Site

Berlin, , Germany

Site Status

Research Site

Roma, , Italy

Site Status

Countries

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Austria Germany Italy

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20120299

Identifier Type: -

Identifier Source: org_study_id

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