Historical Data Analysis of Hematological Remission and Survival in Adults With R/R Acute Lymphoblastic Leukemia

NCT ID: NCT02003612

Last Updated: 2022-11-07

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

2373 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-01

Study Completion Date

2014-04-28

Brief Summary

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A retrospective analysis of historical data looking at hematological remission and survival in adult relapsed / refractory B-precursor acute lymphoblastic leukemia patients.

Detailed Description

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A retrospective observational study reviewing historical survival data (hematological remission and survival) for adult patients who have either relapsed or refractory B-precursor acute lymphoblastic leukemia. Data are aggregated across multiple countries and study sites in the EU and US

Conditions

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Acute Lymphoblastic Leukemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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All subjects

All subjects

Not applicable - observational study

Intervention Type OTHER

No intervention exists as this is a retrospective observational study

Interventions

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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

* adult patients with relapsed / refractory B-precursor acute lymphoblastic leukemia
* age 15 or older at time of de novo (initial) diagnosis of acute lymphoblastic leukemia
* initial diagnosis of acute lymphoblastic leukemia in the year 1990 or later
* No CNS involvement at relapse
* No isolated extramedullary relapse
Minimum Eligible Age

15 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

Boston, Massachusetts, United States

Site Status

Research Site

Cleveland, Ohio, United States

Site Status

Research Site

Brno, , Czechia

Site Status

Research Site

Paris, , France

Site Status

Research Site

Frankfurt am Main, , Germany

Site Status

Research Site

Bologna, , Italy

Site Status

Research Site

Venezia, , Italy

Site Status

Research Site

Gliwice, , Poland

Site Status

Research Site

Badalona, Catalonia, Spain

Site Status

Research Site

London, , United Kingdom

Site Status

Countries

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United States Czechia France Germany Italy Poland Spain United Kingdom

References

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Barlev A, Lin VW, Katz A, Hu K, Cong Z, Barber B. Estimating Long-Term Survival of Adults with Philadelphia Chromosome-Negative Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia Treated with Blinatumomab Using Historical Data. Adv Ther. 2017 Jan;34(1):148-155. doi: 10.1007/s12325-016-0447-x. Epub 2016 Nov 21.

Reference Type DERIVED
PMID: 27873237 (View on PubMed)

Gokbuget N, Dombret H, Ribera JM, Fielding AK, Advani A, Bassan R, Chia V, Doubek M, Giebel S, Hoelzer D, Ifrah N, Katz A, Kelsh M, Martinelli G, Morgades M, O'Brien S, Rowe JM, Stieglmaier J, Wadleigh M, Kantarjian H. International reference analysis of outcomes in adults with B-precursor Ph-negative relapsed/refractory acute lymphoblastic leukemia. Haematologica. 2016 Dec;101(12):1524-1533. doi: 10.3324/haematol.2016.144311. Epub 2016 Sep 1.

Reference Type DERIVED
PMID: 27587380 (View on PubMed)

Related Links

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http://www.amgentrials.com

AmgenTrials clinical trials website

Other Identifiers

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20120310

Identifier Type: -

Identifier Source: org_study_id

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